[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-encephalitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-encephalitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,51,84,108,129,215,243,270,295,325,354,375,401,429,451,469,496,523,542],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100641464","cohort-study-on-neuroimmune-diseases-in-the-reproductive-age-100641464",false,"NCT07653984","Cohort Study on Neuroimmune Diseases in the Reproductive Age","RANID","Inclusion Criteria:\n\n* Patient Group: A total of fifty participants are expected to be enrolled.\n\n  1. Women aged 20-55 years with childbearing potential.\n  2. Voluntary informed consent.\n  3. Availability of complete personal information.\n  4. A confirmed diagnosis of neuromyelitis optica spectrum disorder (NMOSD), multiple sclerosis (MS), autoimmune encephalitis, myasthenia gravis, Guillain-Barré syndrome, or myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).\n\nHealthy Control Group: A total of fifty healthy women are expected to be included.\n\n1. Age- and sex-matched women of childbearing age with plans for pregnancy\n2. Voluntary informed consent.\n3. Availability of complete personal information.\n\nExclusion Criteria:\n\n* Patient Group:\n\n  1. Patients with an undetermined or unconfirmed diagnosis.\n  2. Incomplete personal information that cannot be obtained through follow-up.\n  3. Participants who voluntarily withdrew from the study and revoked informed consent.\n\nHealthy Control Group:\n\n1. Individuals diagnosed with neuroimmune-related disorders.\n2. Incomplete personal information that cannot be obtained through follow-up.\n3. Participants who voluntarily withdrew from the study and revoked informed consent.",true,"FEMALE","20 Years","55 Years",{"count":21,"type":22},100,"ESTIMATED","OBSERVATIONAL","Neuroimmune diseases are more prevalent among women of reproductive age. Studies have shown that neuroimmune diseases may impact fertility. Therefore, effective management of neuroimmune diseases during pregnancy is particularly important. This study included a follow-up period of up to five years in patients with pregnancy-associated neuroimmune disorders. Data collected included relapse frequency, symptomatology, imaging findings, treatment regimens, peripheral blood profiles, EDSS scores, and MRI results. In addition, maternal drug concentrations, postpartum relapse rates, and neonatal development were monitored after delivery. Following the successful completion of the five-year follow-up, the research team plans to continue the prospective epidemiological study with ten-year follow-up phases. The aim of this study is to generate detailed clinical data on pregnancy-associated autoimmune diseases and to equip clinicians with evidence-based strategies for optimizing disease management during the reproductive age.",[26,27,28,29,30,31],"Neuromyelitis Optica Spectrum Disorders (NMOSD)","Multiple Sclerosis","Autoimmune Encephalitis","Myasthenia Gravis","Guillain-Barré Syndrome (GBS)","Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)",[33,27,34,35,30,31,36,37],"Neuromyelitis optica spectrum disorders (NMOSD)","Autoimmune encephalitis","myasthenia gravis","reproductive age","cohort study","RECRUITING","2026-06-13",{"date":41,"type":42},"2026-06-17","ACTUAL",{"date":44,"type":42},"2024-04-21",{"date":46,"type":22},"2030-04",{"name":48,"class":49},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":50},"100600118","phase-2-a-study-in-participants-with-anti-nmdar-encephalitis-and-anti-nmdar-autoantibody-associated-psychiatric-disease-100600118","NCT07093333","A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Autoantibody-Associated Psychiatric Disease","A Phase 2a, Open-label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of ART5803 in Participants With Anti-NMDAR Encephalitis and AntiNMDAR Autoantibody-Associated Psychiatric Disease","7.3.1 Inclusion Criteria Individuals in Cohort A (participants with chronic ANRE) must meet all of the study inclusion criteria in Section 7.3.1.1. Individuals enrolled in Cohort B or Cohort C (participants with subacute or acute ANRE) must meet all of the study inclusion criteria in Section 7.3.1.2. Individuals in Cohort D (participants with anti-NMDAR autoantibody associated psychiatric disease) must meet all of the study inclusion criteria in Section 7.3.1.3.\n\nEligibility for participation in this study will be determined solely based on the participant meeting all protocol-defined inclusion and exclusion criteria. The legally authorized representative (LAR), where applicable, may provide informed consent on behalf of a participant who lacks the capacity to provide consent in accordance with local regulations; however, the LAR does not independently satisfy eligibility criteria. A participant who does not meet all required inclusion and exclusion criteria will not be enrolled in the study, regardless of the availability or status of an LAR.\n\n7.3.1.1 Cohort A Inclusion Criteria The criteria below must be applied to all participants screened for Cohort A (participants with chronic ANRE) of the study.\n\nIndividuals eligible to participate in Cohort A must meet all the following criteria:\n\n1. The participant is a male or female who is of legal age to provide informed consent per local regulations, and ≤65 years of age at the time of informed consent. For the purposes of this study, the minimum age is 19 years in South Korea and 18 years in Australia.\n2. The participant, or their legally authorized representative (LAR), must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures. For participants who are unable to sign the consent form themselves, informed consent must be obtained from their LAR in accordance with local regulations and ethical guidelines.\n3. The participant, or their LAR, must ensure willingness and ability to comply with all study procedures to the extent possible, as determined by the Investigator.\n4. The participant has a diagnosis of ANRE according to the Graus et al criteria (Graus et al, 2016), with symptom onset \\>9 months to ≤36 months (or ≤120 months with Sponsor approval) prior to Week 0, Day 0.\n5. The participant has a positive cell-based assay result for CSF anti-NMDAR IgG autoantibody within 9 months of Week 0, Day 0. Participants without a positive CSF anti-NMDAR IgG autoantibody result within 9 months of Week 0, Day 0 may undergo a LP at Screening prior to the first study drug administration to confirm the presence of anti-NMDAR IgG autoantibodies in CSF (see Section 7.6.4.6.1).\n\n   Note: If the participant has a documented history of positive anti-NMDAR IgG autoantibodies in CSF \\>9 months of Week 0, Day 0, they may be considered for inclusion in the study with confirmed positive anti-NMDAR IgG autoantibodies in serum at Screening at the discretion of the Investigator in collaboration with the Sponsor (see Section 7.6.4.6.1).\n6. Participants treated with IVIG must have completed treatment at least 7 days prior to Week 0, Day 0.\n7. Participants previously treated with immunotherapy must be receiving a stable dose (per Investigator discretion) for ≥1 month before Week 0, Day 0.\n8. Participants who are taking psychiatric medications (anti-depressants and antipsychotics) must remain on stable background psychiatric medications for at least 4 weeks prior to Week 0, Day 0 and for at least the first 6 weeks after Week 0, Day 0.\n9. Adequate disease burden as defined as any one of the following (a to c) at Screening and Week 0, Day 0:\n\n   a. Two of the following: i. WAIS-IV immediate recall score \\\u003C7 ii. TMT-A \\>40 seconds iii. RAVLT score \\\u003C7 b. BDI-II total score ≥20. c. EQ 5D-5L score \"moderate\" or higher on at least 3 of the 5 items. Exceptions may be granted on a case-by-case basis in consultation with the Sponsor.\n10. No active malignancy (see Section 7.6.3.3) or residual teratoma. Prior teratoma must be fully resected ≥1 week before Week 0, Day 0 with no evidence of recurrence per work-up (imaging and tumor markers).\n\n    Note: Discovery of a contralateral teratoma after study initiation will not be considered a protocol deviation. The event must be reported, managed per standard of care, and reviewed with the Sponsor Medical Monitor.\n\n    Participants must have undergone appropriate cancer screening prior to study enrollment. The specific series of investigations used for each participant will occur according to the judgment of the treating Investigator (for example, MRI or CT of the chest, abdomen, and pelvis, and pelvic ultrasound for female participants) to exclude the presence or recurrence of an underlying neoplasm, such as ovarian teratoma or other malignancy. Documentation of imaging results must be available in the source documents.\n11. Sexually active female participants of childbearing potential and male participants with female partner(s) of childbearing potential must be willing to use a highly effective method of contraception during the study (from the time of providing consent) until at least 90 days after the last study drug administration, or longer if required by local regulations.\n\n    In South Korea, contraception must be continued for 6 months after the last study drug administration in accordance with MFDS requirements.\n\n    Examples of highly effective methods of contraception are provided in Appendix 1. The contraceptive methods used for male and female participants must be documented in the source documents.\n12. Female participants of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who are surgically sterile (surgical bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) confirmed by medical history or are post-menopausal (i.e., no menstrual bleeding for more than 2 years without an alternative medical cause and confirmation with more than 1 follicle stimulating hormone \\[FSH\\] measurement of at least \\>40 IU\u002FL \\[or higher per local institutional guidelines\\]).Women of non-childbearing potential are not required to use any contraceptive method (see Appendix 1).\n13. Male participants must agree not to donate sperm, and female participants must agree not to donate eggs from the first study drug administration and until at least 90 days after the last dose of the study drug, or longer if required by local regulations.\n\n    In South Korea, male participants must refrain from donating sperm for 6 months after the last study drug administration in accordance with MFDS requirements.\n14. Compliance with these restrictions must be documented at Screening and confirmed throughout the study.\n\n7.3.1.2 Cohort B and Cohort C Inclusion Criteria The criteria below must be applied to all participants screened for Cohort B (participants with subacute ANRE) or Cohort C (participants with acute ANRE) of the study.\n\nIndividuals eligible to participate in Cohort B or C must meet all of the following criteria:\n\n1. The participant is a male or female who is of legal age to provide informed consent per local regulations, and ≤65 years of age at the time of informed consent. For the purposes of this study, the minimum age is 19 years in South Korea and 18 years in Australia.\n2. The participant, or their LAR, must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures. For participants who are unable to sign the consent form themselves, informed consent must be obtained from their LAR in accordance with local regulations and ethical guidelines.\n3. The participant, or their LAR, must ensure willingness and ability to comply with all study procedures to the extent possible, as determined by the Investigator.\n4. The participant has a diagnosis of ANRE according to the Graus et al criteria (Graus et al, 2016), with symptom onset ≥4 months and ≤9 months (Cohort B) or ≥0 months and \\\u003C4 months (Cohort C) prior to Week 0, Day 0.\n5. Participants with ANRE symptoms as assessed by the mRS with a score of ≥3 during Screening and Week 0, Day 0.\n6. The participant has a positive cell-based assay result for CSF anti-NMDAR IgG autoantibody within 9 months for Cohort B and 4 months for Cohort C prior to Week 0, Day 0. Participants without a positive CSF anti-NMDAR IgG autoantibody result within 9 months for Cohort B and 4 months for Cohort C of Week 0, Day 0 may undergo a LP at Screening prior to the first study drug administration to confirm the presence of anti-NMDAR IgG autoantibodies in CSF (see Section 7.6.4.6.1).\n\n   Note: If the participant documented history of positive anti-NMDAR IgG autoantibodies in CSF \\>9 months for Cohort B and \\>4 months for Cohort C, they may be considered for inclusion in the study with confirmed positive anti-NMDAR IgG autoantibodies in serum at Screening at the discretion of the Investigator in collaboration with the Sponsor (see Section 7.6.4.6.1).\n7. Participants treated with IVIG must have completed treatment at least 7 days prior to Week 0, Day 0.\n8. Immunotherapy:\n\n   1. Cohort B: Participants previously treated with immunotherapy must be receiving a stable dose (per Investigator discretion) for ≥1 month before Week 0, Day 0.\n   2. Cohort C: Participants may receive ART5803 regardless of previous or ongoing immunotherapy treatment status (per the Investigator's discretion).\n9. Participants who are taking psychiatric medications (anti-depressants and anti psychotics) must remain on stable background psychiatric medications for at least 4 weeks prior to Week 0, Day 0 and for at least the first 6 weeks after Week 0, Day 0.\n10. Participants treated with plasmapheresis must have completed treatment at least 1 day prior to Week 0, Day 0.\n11. Participants receiving steroids must be on a stable dose or a predefined taper regimen for at least 2 weeks prior to Week 0, Day 0.\n12. No active malignancy (see Section 7.6.3.3) or residual teratoma. Prior teratoma must be fully resected ≥1 week before Week 0, Day 0 with no evidence of recurrence per work-up (imaging and tumor markers).\n\n    Note: Discovery of a contralateral teratoma after study initiation will not be considered a protocol deviation. The event must be reported, managed per standard of care, and reviewed with the Sponsor Medical Monitor.\n13. Participants must have undergone appropriate cancer screening prior to study enrollment. The specific series of investigations used for each participant will occur according to the judgment of the treating Investigator (for example, MRI or CT of the chest, abdomen, and pelvis, and pelvic ultrasound for female participants) to exclude the presence or recurrence of an underlying neoplasm, such as ovarian teratoma or other malignancy. Documentation of imaging results must be available in the source documents.\n14. Sexually active female participants of childbearing potential and male participants with female partner(s) of childbearing potential must be willing to use a highly effective method of contraception during the study (from the time of providing consent) until at least 90 days after the last study drug administration, or longer if required by local regulations.\n\n    In South Korea, contraception must be continued for 6 months after the last study drug administration in accordance with MFDS requirements.\n\n    Examples of highly effective methods of contraception are provided in Appendix 1. The contraceptive methods used for male and female participants must be documented in the source documents.\n15. Female participants of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who are surgically sterile (surgical bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) confirmed by medical history or are post-menopausal (i.e., no menstrual bleeding for more than 2 years without an alternative medical cause and confirmation with more than 1 FSH measurement of at least \\>40 IU\u002FL \\[or higher per local institutional guidelines\\]).Women of non-childbearing potential are not required to use any contraceptive method (see Appendix 1).\n16. Male participants must agree not to donate sperm and female participants must agree not to donate eggs, from the first study drug administration and until at least 90 days after the last dose of the study drug, or longer if required by local regulations.\n\n    In South Korea, male participants must refrain from donating sperm for 6 months after the last study drug administration in accordance with MFDS requirements.\n17. Compliance with these restrictions must be documented at Screening and confirmed throughout the study.\n\n7.3.1.3 Cohort D Inclusion Criteria The criteria below must be applied to all participants screened for Cohort D (participants with anti-NMDAR autoantibody-associated psychiatric disease) of the study.\n\nIndividuals eligible to participate in Cohort D must meet all of the following criteria:\n\n1. The participant is a male or female who is of legal age to provide informed consent per local regulations, and ≤65 years of age at the time of informed consent. For the purposes of this study, the minimum age is 19 years in South Korea and 18 years in Australia.\n2. The participant, or their LAR, must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures. For participants who are unable to sign the consent form themselves, informed consent must be obtained from their LAR in accordance with local regulations and ethical guidelines.\n3. The participant, or their LAR, must ensure willingness and ability to comply with all study procedures to the extent possible, as determined by the Investigator.\n4. The participant has persistent psychotic symptoms for at least 2 months prior to Screening and Week 0, Day 0 as evaluated by the Investigator.\n5. The participant has marked deterioration of functioning in one or more areas, such as occupational, social, or personal care or hygiene.\n6. The participant has the documented presence of:\n\n   1. Anti-NMDAR autoantibodies in CSF within 6 months of Week 0, Day 0; or\n   2. Positive CSF anti-NMDAR autoantibody within 12 months of Week 0, Day 0 and positive serum anti-NMDAR autoantibody during Screening (see Section 7.6.4.6.1).\n7. Participants treated with IVIG must have completed treatment at least 7 days prior to Week 0, Day 0.\n8. Participants previously treated with immunotherapy must be receiving a stable dose (per Investigator discretion) for ≥1 month before Week 0, Day 0.\n9. Participants who are taking psychiatric medications (anti-depressants and anti psychotics) must remain on stable background psychiatric medications for at least 4 weeks prior to Week 0, Day 0 and for at least the first 6 weeks after Week 0, Day 0.\n10. Adequate disease burden as defined as both of the following:\n\n    a. Participant must have a Positive and Negative Syndrome Scale (PANSS) total score ≥70 and a PANSS item score ≥4 (moderate) on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, suspiciousness, and unusual thought content at Screening and Week 0, Day 0.\n\n    Exceptions may be granted on a case-by-case basis in consultation with the Sponsor.\n11. Sexually active female participants of childbearing potential and male participants with female partner(s) of childbearing potential must be willing to use a highly effective method of contraception during the study (from the time of providing consent) until at least 90 days after the last study drug administration, or longer if required by local regulations.\n\n    In South Korea, contraception must be continued for 6 months after the last study drug administration in accordance with MFDS requirements.\n\n    Examples of highly effective methods of contraception are provided in Appendix 1. The contraceptive methods used for male and female participants must be documented in the source documents.\n12. Female participants of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who are surgically sterile (surgical bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) confirmed by medical history or are post-menopausal (i.e., no menstrual bleeding for more than 2 years without an alternative medical cause and confirmation with more than 1 FSH measurement of at least \\>40 IU\u002FL \\[or higher per local institutional guidelines\\]).Women of non-childbearing potential are not required to use any contraceptive method (see Appendix 1).\n13. Male participants must agree not to donate sperm and female participants must agree not to donate eggs, from the first study drug administration and until at least 90 days after the last dose of the study drug, or longer if required by local regulations.\n\n    In South Korea, male participants must refrain from donating sperm for 6 months after the last study drug administration in accordance with MFDS requirements.\n14. Compliance with these restrictions must be documented at Screening and confirmed throughout the study.\n\n7.3.2 Exclusion Criteria Individuals (Cohorts A, B, C, or D) will not be eligible to participate in the study if they meet any of the exclusion criteria.\n\n1. The participant is pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study.\n2. The participant has used an investigational product (IP) or investigational medical device within 30 days or 5 half-lives of the other IP (whichever is longer) prior to Screening or is required to use any investigational agent prior to completion of all scheduled study assessments.\n3. The participant has used an NMDAR modulator other than the study drug (e.g., ketamine, memantine, dextromethorphan, amantadine, ifenprodil, phencyclidine, acamprosate, D-cycloserine) from within 5 half-lives of the NMDAR modulator prior to Week 0, Day 0.\n4. The participant has previous exposure to ART5803 or other antibody that targets NMDAR.\n5. Participant has any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the IP, interpretation of participant safety or study results, or would make participation in the study an unacceptable risk.\n6. Participant with coexisting CNS demyelinating disorders (e.g., multiple sclerosis), known positivity to other autoantibodies associated with autoimmune encephalitis, or any significant history of a psychiatric or neurologic disorder other than ANRE should undergo consultation with the Sponsor Medical Monitor on a case-by-case basis for eligibility determination. MOG antibody positivity may be permitted on a case-by-case basis if the condition is clinically inactive and not expected to confound study assessments.\n7. The participant has a confirmed positive test for hepatitis B serology (hepatitis B surface antigen and core antigen) and\u002For hepatitis C polymerase chain reaction at Screening.\n8. The participant has a known history of allergy or reaction to any component of the investigational agent (ART5803), or history of anaphylaxis following any biologic therapy.\n9. The participant has a history (within 12 months prior to Screening for Cohorts A, B, or C) or current (for Cohort D) alcohol abuse or drug addiction, defined as moderate or severe substance use disorder per Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition, or any pattern of alcohol or substance use that, in the Investigator's judgment and after discussion with the","ALL","18 Years","65 Years",{"count":62,"type":22},30,"INTERVENTIONAL",[65],"PHASE2","This study will evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics (PK) of ART5803 in adult participants with a confirmed diagnosis of anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis (ANRE) or anti-NMDAR autoantibody-associated psychiatric disease",[68,69,28],"Anti-N-methyl-D-aspartate Receptor (NMDAR) Encephalitis (ANRE)","Anti-N-methyl-D-aspartate Receptor (NMDAR) Antibody-associated Psychiatric Disease",[71,72,73],"Anti-N-methyl-D-aspartate receptor (NMDAR)","Encephalitis","Anti-N-methyl-D-aspartate receptor (NMDAR) Encephalitis","2026-05-07",{"date":76,"type":42},"2026-05-12",{"date":78,"type":22},"2026-05-15",{"date":80,"type":22},"2028-05-30",{"name":82,"class":83},"Arialys Australia Pty Ltd","INDUSTRY",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":58,"minAge":4,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100517625","fdg-pet-in-the-diagnosis-of-autoimmune-encephalitis-100517625","NCT06019975","FDG-PET in the Diagnosis of Autoimmune Encephalitis","PEA","Inclusion Criteria:\n\n* Diagnosis of autoimmune encephalitis according to clinical criteria\n* Brain magnetic resonance imaging performed between clinical presentation and treatment\n* Cerebrospinal fluid analysis performed between clinical presentation and treatment\n* Brain FDG-PET performed between clinical presentation and treatment\n* Autoantibodies testing performed between clinical presentation and treatment\n\nExclusion Criteria:\n\n* Refusal to give consent for the study",{"count":92,"type":22},90,"The goal of this retrospective observational study is to compare brain fluorodeoxyglucose-positron emission tomography (FDG-PET) of patients with autoimmune encephalitis, normal controls and patients with Alzheimer's disease (AD). The main question it aims to answer is:\n\n•is there a specific pattern of brain metabolism in patients with autoimmune encephalitis Participants data and images will be retrospectively collected from hospital records, and FDG-PET images will be analyzed by means of statistical parametric mapping (SPM). Controls will be selected from validated public databases.",[28],[28,96,97],"FDG-PET","SPM","2026-03-23",{"date":100,"type":42},"2026-03-24",{"date":102,"type":42},"2023-03-01",{"date":104,"type":22},"2027-04-30",{"name":106,"class":49},"University of Milano Bicocca",6,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":50},"100629618","study-of-pathogenic-mechanisms-and-identification-of-novel-autoantibodies-in-autoimmune-encephalitis-100629618","NCT07477015","Study of Pathogenic Mechanisms and Identification of Novel Autoantibodies in Autoimmune Encephalitis","Study of Pathogenic Mechanisms and Identification of Novel Autoantibodies in Autoimmune Encephalitis Through the Integration of Conventional Methodologies and Advanced Single-cell Technologies","AE_Abs","Inclusion Criteria:\n\n* Patients \\> 18 years of age\n* Patients able to provide informed consent\n* For the patient group: patients diagnosed with autoimmune encephalitis associated with anti-NMDAR, GABABR, AMPAR, LGI-1, DNER antibodies, seronegative autoimmune encephalitis, or Susac syndrome, without other concomitant autoimmune diseases\n* For the control group: patients without a diagnosis of autoimmune encephalitis associated with anti-NMDAR, GABABR, AMPAR, LGI-1, DNER antibodies, seronegative autoimmune encephalitis, or Susac syndrome\n* For the control group: patients with other neurological disorders in whom the presence of antibodies against neuronal antigens has been excluded\n\nExclusion Criteria:\n\n* Patients ≤ 18 years of age\n* Deceased patients",{"count":117,"type":22},20,"Autoimmune encephalitis is a debilitating neurological disorder that usually appears as a rapidly progressive form of brain dysfunction, typically developing in less than six weeks, caused by inflammation in the brain. These conditions show a wide range of clinical and immunological presentations and are generally divided into two main types.\n\nThe first type includes what are called paraneoplastic syndromes. In these cases, the immune system produces antibodies in response to a tumor that mistakenly target parts of the nervous system. The antibodies are not directly harmful themselves, but they are a sign that the immune system has launched a T-cell-driven attack on brain tissue because it recognizes a protein that's found both in the tumor and in the nervous system. These forms usually follow a single, non-repeating course and tend to respond poorly to treatment, which mostly focuses on removing or treating the underlying tumor and using immunotherapy to reduce the immune response.\n\nThe second type includes what we more properly call autoimmune encephalitis, where the immune system produces antibodies that directly attack proteins on the surface of neurons or on synaptic receptors in the brain. Unlike in paraneoplastic syndromes, these antibodies are directly responsible for the disease, and they don't usually indicate the presence of a tumor. Most people with this type of autoimmune encephalitis-around 70% to 80%-respond well to treatment with immunotherapy and can make a good or even full recovery. However, in about 20% of cases, the disease can come back or lead to long hospital stays, with a slower or only partial recovery.\n\nThere is also a third group of autoimmune encephalitides where the antibodies target synaptic proteins. These may or may not be linked to cancer, and the proteins they target are usually found inside the cells rather than on their surface.\n\nA fourth group includes what are called seronegative autoimmune encephalitides. These are cases that meet the clinical criteria for autoimmune encephalitis, but no specific antibodies have been identified so far. Among the autoimmune neurological disorders without known antibodies is Susac syndrome, a rare condition that affects the brain, the retina, and the inner ear. It's especially interesting because its features suggest the involvement of antibodies, even though no disease-causing antibodies have yet been found.\n\nThe diagnosis of autoimmune encephalitis is based on clinical signs and symptoms, the detection of specific antibodies in blood or spinal fluid, and, in paraneoplastic cases, identifying the underlying tumor. To detect autoantibodies, doctors use various lab techniques, including immunoblotting and different types of immunofluorescence tests-some based on cultured cells, others on brain tissue from rodents.\n\nDespite important progress in recent years, many cases of autoimmune encephalitis remain undiagnosed. One reason is that the disease can begin with vague or incomplete symptoms, making it difficult to recognize. Another issue is that current testing methods might not be sensitive enough to detect all possible antibodies. This means that the group of patients diagnosed with seronegative autoimmune encephalitis might actually include people who have antibodies we just haven't discovered yet.\n\nIn many cases, especially in the seronegative forms, the exact cause of the disease is still not fully understood.\n\nThe main goal of this study is to better understand how autoimmune encephalitis develops, especially in cases involving antibodies that target proteins on the surface of brain cells-such as NMDAR, GABABR, AMPAR, LGI1, and DNER-as well as in seronegative autoimmune encephalitis and in Susac syndrome. A second goal is to try to discover new autoantibodies that could explain the disease in patients who currently test negative.",[28],"2026-03-12",{"date":122,"type":42},"2026-03-17",{"date":124,"type":42},"2025-07-31",{"date":126,"type":22},"2028-12-31",{"name":128,"class":49},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":16,"sex":58,"minAge":136,"maxAge":4,"enrollmentInfo":137,"targetDuration":139,"studyType":23,"phases":4,"briefSummary":140,"conditions":141,"keywords":184,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":50},"100424417","unhide-project-a-digital-health-platform-to-collect-lifestyle-data-for-brain-inflammation-research-100424417","NCT04806620","Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research","Unhide® Project Also Known as The Unhide® Solve Together Unified Platform","Participants may be either self-diagnosed, or diagnosed by a physician with the following conditions:\n\n* Infection-associated chronic conditions such as Long COVID, chronic Lyme, myalgic encephalomyelitis (ME\u002FCFS), and post-acute neuropsychiatric syndrome (PANS\u002FPANDAS).\n* Neuroimmune, developmental, autonomic, and neurological conditions like migraines, dysautonomia, POTS, multiple sclerosis, and autism spectrum disorder.\n* Autoimmune diseases such as Lupus, Sjogren's Disease, rheumatoid arthritis, myasthenia gravis, ankylosing spondylitis, and related autoimmune conditions.\n\nInflammatory gastrointestinal conditions such as Crohn's Disease, Celiac Disease, and ulcerative colitis.\n\n* Behavioral and mood disorders such as anxiety, depression, bipolar disorder, PTSD, eating disorders, OCD, and other related conditions.\n* \"Healthy\" people (without brain inflammation), including unaffected individuals, unaffected individuals in the same household, and unaffected individuals who are married to relatives and family members.\n* Have consistent internet access and a cell phone, tablet, or PC since this is an online or app-based platform that requires entering data and completing surveys.\n* Currently live in the United States\n* Be able to participate in English (stay tuned for updates about the Spanish language version)\n* Be willing to share symptom and health data through the platform","2 Years",{"count":138,"type":22},10000,"10 Years","The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. \"Healthy\" individuals without brain inflammation are also eligible to participate.\n\nThe digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.",[142,143,144,145,146,147,28,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,27,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183],"Post-Acute COVID-19 Syndrome","ME\u002FCFS","Rheumatic Arthritis","Juvenile Rheumatoid Arthritis (JRA)","Psoriatic Arthritis (PsA)","Ankylosing Spondylitis (AS)","Celiac Disease","Celiac Disease in Children","Chronic Lyme Disease","Post-treatment Lyme Disease Syndrome","Crohn's Disease","Dysautonomia","Anorexia Nervosa","Bulimia Nervosa","ARFID","Avoidant \u002F Restrictive Food Intake Disorder","Ehlers Danlos Syndrome","Endometriosis","Fibromyalgia (FM)","Long COVID","Lupus","Migraines","Mast Cell Activation Syndrome","Myalgic Encephalomyelitis (ME)","Myasthenia Gravis, Generalized","Myasthenia Gravis in Children","Narcolepsy","Obsessive Compulsive Disorder (OCD)","PANDAS","Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)","POTS - Postural Orthostatic Tachycardia Syndrome","General Anxiety Disorder, Social Anxiety Disorder","PTSD - Post Traumatic Stress Disorder","Psoriasis","Traumatic Brain Injury","Tourette's Syndrome","Inflammatory Bowel Disease (IBD)","Autoimmune Diseases","Neurological Diseases or Conditions","Psychiatric Disorder","Sjogren's Syndrome","Ulcerative Colitis and Crohn's Disease",[161,185,186,187,188,189,190,191,192,34,143,193,194,195,196,197,163,198,199,200,201,202,203,204,205],"Myalgic Encephalomyelitis","Chronic Fatigue Syndrome","Longitudinal Natural History Study","Observational","Neuroinflammatory Disease","Brain inflammation","Neuroinflammatory disorders","PANS\u002FPANDAS","Dysautonomia \u002F POTS","Multiple sclerosis","Autoimmune disease","Inflammatory bowel disease (Crohn's, ulcerative colitis)","Celiac disease","Mood disorders (anxiety, depression, bipolar, PTSD, OCD)","Mobile health app","Patient registry","Wearable devices","Fatigue","Post-exertional malaise","Brain Fog","Mental health","2026-01-20",{"date":208,"type":42},"2026-01-22",{"date":210,"type":42},"2023-07-05",{"date":212,"type":22},"2030-12-31",{"name":214,"class":49},"Brain Inflammation Collaborative",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":222,"enrollmentInfo":223,"targetDuration":139,"studyType":23,"phases":4,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":50},"100618559","tongji-nads-cohort-100618559","NCT07333196","Tongji NADs Cohort","Tongji NADs Cohort: A Real-world Observation of Neurological Autoimmune Disorders","Inclusion Criteria:\n\n* Participants must meet the following eligibility criteria at the time of screening to participate in this study.\n\n1.1. The subject is able to understand the purpose and risks of the study, provide informed consent and authorize the use of confidential health information in accordance with national and local privacy regulations.\n\n1.2. Open to both men and women, aged 18-80 years (inclusive) at the time of informed consent.\n\n1.3. Must be diagnosed with one of the following conditions:\n\n1.3.1. This study adhered to the 2017 McDonald criteria for diagnosing multiple sclerosis:\n\n1. ≥2 clinical episodes with ≥2 objective clinical evidences of lesions.\n2. ≥2 clinical episodes with one clear historical evidence of the lesion involving specific anatomical site.\n3. ≥2 clinical episodes with objective clinical evidence of one lesion, and spatial multiplicity confirmed by clinical episodes in different CNS sites or MRI findings.\n4. A single episode with ≥2 objective clinical evidences, confirmed by additional clinical episodes or MRI showing temporal multiple lesions or OCB positivity.\n5. A single episode with one objective clinical manifestation, confirmed by clinical seizures or MRI scans across multiple CNS regions to demonstrate spatial multiplicity, and further supported by additional clinical episodes or MRI findings to confirm temporal multiplicity or OCB positivity.\n6. Indication for the progressive multifocal sclerosis (PPMS) phase: Disease progression at 1 year (confirmed retrospectively or prospectively), with two of the following three criteria: \\[1\\] Spatially multifocal evidence of brain lesions: ≥1 T2-weighted lesion in characteristic MS regions (periventricular, corticoprotuberant, or subarachnoid) \\[2\\] Spatially multifocal evidence of spinal lesions: ≥2 T2-weighted lesions in the spinal cord \\[3\\] OCB positivity.\n\n1.3.2. This study adhered to the 2015 IPND diagnostic criteria for adult neuromyelitis optica spectrum disorders:\n\n1. NMOSD diagnosis with AQP4-IgG positivity: meeting ≥1 core clinical feature, confirmed by reliable AQP4-IgG detection (CBA method recommended), and excluding other diagnoses.\n2. Diagnostic criteria for NMOSD with AQP4-lgG negative or undetermined status: In at least one clinical episode, the presence of ≥2 core clinical features meeting all of the following criteria: ①≥1 core clinical feature is ON, acute LETM, or bulbar syndrome; ②≥2 distinct core clinical features; ③MRI supplementary criteria are satisfied. AQP4-lgG should be reliably detected as negative or undetected, and other diagnoses must be excluded.\n\nNote: Core clinical features include six cardinal signs: optic neuritis (ON), acute myelitis (LETM), and the final area syndrome (unexplained paroxysmal hiccups, nausea, and vomiting); other brainstem syndromes; symptomatic narcolepsy\u002Fhypothalamic syndrome with characteristic hypothalamic MRI lesions; and brain syndrome with characteristic cerebral MRI lesions.\n\nMRI diagnostic criteria: Acute optic neuritis (ON) requires MRI demonstrating one of the following: ① Normal brain MRI or non-specific white matter lesions; ② Long T-weighted signal or T-weighted enhancement exceeding 1\u002F2 of optic nerve length, or optic chiasm involvement; ③ Acute myelitis (LETM) requires three or more consecutive vertebral segments with spinal cord lesions, or spinal cord atrophy exceeding three consecutive vertebral segments in patients with myelitis history; ④ Final region syndrome: lesions in the dorsal medulla or final region. Acute brainstem syndrome: periventricular lesions in the brainstem.\n\n1.3.3. This study adhered to the MOGAD diagnostic criteria established by the International Parkinson's Disease and Movement Disorders (IPMD) in 2023:\n\n1. A diagnosis of MOGAD can be confirmed when: (a) fixed or live-cell CBA detects strong positivity of MOG-IgG in serum with ≥1 core clinical manifestation, and (b) other diagnoses (e.g., MS, NMOSD) are excluded;\n2. If the CBA shows weak positivity of MOG-IgG in serum, or MOG-IgG positivity without titer, or negative serum MOG-IgG with strong positivity in cerebrospinal fluid (CSF), the diagnosis requires: 1) ≥1 core clinical manifestation, 2) ≥1 supporting clinical or imaging feature, 3) negative serum AQP4-IgG, and 4) exclusion of other diagnoses (e.g., MS, NMOSD).\n\nNote: The core clinical features include six main signs: optic neuritis, myelitis, acute disseminated encephalomyelitis, monofocal or multifocal cerebral dysfunction, brainstem or cerebellar functional deficits, and cerebral cortex inflammation with epilepsy.\n\nTypical MRI imaging features: ① Optic Neuropathy (ON): Bilateral optic nerve involvement with long-segment optic nerve damage (\\>50% optic nerve length), optic nerve sheath enhancement, and papilledema. ② Myelitis: Long-segment transverse myelitis with central spinal cord damage or \"H\" sign, and conus medullaris damage. ③ Cerebral, brainstem, or cerebral cortex symptoms: Multifocal ill-defined T2 hyperintense lesions in supratentorial and infratentorial white matter, deep gray matter involvement, ill-defined T2 hyperintense lesions in pons, cerebellar midfoot, or medulla oblongata, and cortical lesions with or without focal enhancement and local dural enhancement.\n\nThe strong positive result of serum and cerebrospinal fluid MOG-IgG was defined as the value of the live CBA was more than 2 times the detection limit or the fixed CBA titer was ≥1:100. The weak positive result was defined as the value of the live CBA was in the lower range or the fixed CBA titer was ≥1:10 but less than 1:100.\n\n1.3.4. This study followed the expert consensus on the diagnosis and treatment of autoimmune encephalitis in China (2022 edition)\n\n1. Possible AE: meeting the following three diagnostic criteria A, B, and D; confirmed AE: meeting the four diagnostic criteria A, B, C, and D.\n2. Diagnostic criteria:\n\nA. Clinical presentation: Acute or subacute onset (\\\u003C3 months) with ≥1 of the following neurological or psychiatric symptoms or clinical syndromes: limbic system symptoms, encephalitis syndrome, lymphocytic inflammation in cerebrospinal fluid cytology, and positive specific oligoclonal bands.\n\nB. Neuroimaging or electrophysiological abnormalities: T2 or FLAIR abnormal signals in the limbic system (unilateral or bilateral), or T2\u002FFLAIR abnormalities in other regions (excluding nonspecific white matter changes and stroke); or PET findings of high metabolism in the limbic system, or multiple high metabolic areas in the cortex and\u002For basal ganglia; or EEG abnormalities such as focal epilepsy or epileptiform discharges (in the temporal lobe or outside it), or diffuse or multifocal slow-wave rhythms.\n\nC. Diagnostic test: Positive for anti-neuronal antibodies. D. Reasonably rule out other possible causes.\n\n1.3.5. This study adhered to the diagnostic criteria for AIDP, CIDP, and autoimmune Ranvier node disease:\n\n1. AIDP: Essential features include: ① Progressive weakness in the upper and\u002For lower limbs, ranging from mild bilateral lower limb weakness to complete paralysis of all limbs (including trunk, medullary muscles, and facial muscles) and oculomotor muscle paralysis; ② Weakened or absent deep tendon reflexes in the affected limbs; ③ Symptom progression ≤4 weeks. Supporting features include: ① Symptom progression from days to 4 weeks; ② Relatively symmetrical bilateral symptoms; ③ Trunk or limb pain; ④ Cranial nerve symptoms or signs; ⑤ Autonomic dysfunction; ⑥ Respiratory insufficiency; ⑦ Mild or absent sensory dysfunction; ⑧ History of prodromal systemic infection in approximately 70% of cases; ⑨ No fever at symptom onset; ⑩ Elevated cerebrospinal fluid protein with normal or mildly elevated white blood cell count (\\\u003C5 mm³); ⑪ Electrophysiological examination showing abnormalities consistent with Guillain-Barré syndrome (GBS); ⑫ Recovery begins 2-4 weeks after symptom stabilization.\n2. CIDP: CIDP develops in 2%-5% of patients initially diagnosed with AIDP, with the following clinical features: ① Progressive or recurrent disease progression lasting over 8 weeks; ② Only approximately 30% of patients experience prodromal events; ③ Additional supporting features include: ≥3 acute relapses or exacerbations occurring ≥8 weeks after symptom onset, milder symptoms, preserved independent walking ability throughout the disease course, and absence of cranial nerve involvement or frequent respiratory system involvement.\n3. Autoimmune Ranvier node disease:\n\n   * Clinical manifestations: a. Acute, subacute or chronic course, with persistent progression after 8 weeks of onset; b. Clinical features consistent with polyneuropathy; c. May be accompanied by significant ataxia, tremor or neuropathic pain; d. May be associated with nephrotic syndrome.\n   * Electrophysiological findings: a. Motor nerve conduction tests reveal prolonged distal motor latency, slowed conduction velocity, abnormal waveform dispersion, and conduction block, with decreased F-wave conduction velocity, consistent with myelination abnormalities; b. Both motor and sensory nerve conduction show markedly reduced amplitude. Electromyography (EMG) at needle electrodes demonstrates abnormal spontaneous potentials and decreased recruitment, indicating early axonal damage.\n   * Antibody detection: serum anti-Langfei junction antibody was positive, especially serum anti-NF155, anti-CNTN1, anti-Casp1 and anti-NF140\u002F186 antibody.\n   * Cerebrospinal fluid (CSF) analysis: Protein-cell dissociation is observed, with CSF protein levels typically showing significant elevation.\n\n1.3.6. This study adheres to the diagnostic criteria of the 2024 China Expert Consensus on the Diagnosis and Treatment of Refractory Systemic Myasthenia Gravis\n\n1. Basic conditions\n\n   ① Meet the diagnostic criteria in the China Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 edition).\n\n   ② The patient's Myasthenia Gravis Activities of Daily Living (MG-ADL) score was ≥6, and the ocular muscle score was less than 50% of the total score.\n2. Diagnostic criteria:\n\n   * After adequate duration of treatment with at least two conventional immunotherapeutic agents (including both corticosteroids and non-corticosteroid immunosuppressants), the post-intervention status (PIS) remains unchanged or worsens.\n   * After adequate doses and duration of at least two conventional immunotherapeutic drugs, the PIS showed improvement, but the MG-ADL score remained ≥6 points for at least six months.\n   * After adequate duration of treatment with at least two conventional immunotherapeutic agents, the PIS was remitted or improved, but during the regular tapering of immunotherapy, disease symptoms worsened ≥2 times per year (MG-ADL score ≥6).\n   * Patients who, after a crisis, received multiple immunotherapies including intravenous immunoglobulin (IVIG), plasma exchange, and high-dose intravenous methylprednisolone (IVMP), along with active infection control, still remained unable to wean off mechanical ventilation for more than 14 days due to MG-induced respiratory muscle weakness.\n\nDiagnostic criteria: meeting all the above basic conditions plus 1 of the 4 diagnostic conditions.\n\n1.3.7. This study adheres to the 2017 diagnostic criteria for idiopathic inflammatory myopathy (IIM) established by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR), following the EULAR\u002FACR classification system. Patients with a probability score ≥55% in the table below are considered suspected IIM cases. Suspected IIM patients can be diagnosed with dermatomyositis in adults if they meet the following criteria: ① Age ≥18 years at first onset of IIM-related symptoms; ② Presence of Heliotrope sign, Gottron papules, or Gottron sign; ③ Objective proximal symmetrical arm weakness (confirmed by manual muscle strength testing or other strength assessment methods), typically progressive, or objective proximal symmetrical leg weakness, typically progressive, or more pronounced neck flexor weakness than neck extensor weakness, or more pronounced proximal leg weakness than distal leg weakness. If patients meet criteria ① and ② but not ③, they may be diagnosed with non-myopathic dermatomyositis. Compared to previous standards, this criterion demonstrates higher sensitivity and specificity. In this standard, patients with typical clinical manifestations (such as characteristic rashes) do not require further tests (e.g., muscle biopsy), while some patients without typical rashes may be missed.\n\nExclusion Criteria:\n\n* This is an observational study with no specific exclusion criteria.\n* The investigators identified other unexplained factors that may have disqualified participants from enrollment.","80 Years",{"count":224,"type":22},1550,"Neurological Autoimmune Diseases (NADs) are disorders caused by abnormal immune system attacks on neural tissues, affecting multiple systems including the central nervous system, peripheral nervous system, and neuromuscular junctions. This study examines clinically significant NADs such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), myelin oligodendrocyte glycoprotein G antibody-related diseases (MOGAD), autoimmune encephalitis (AE), immune-mediated peripheral neuropathy (PN), myasthenia gravis (MG), and idiopathic inflammatory myopathy (IIM). While sharing the core pathogenesis of autoimmune response, these diseases exhibit significant heterogeneity in epidemiological patterns, clinical manifestations, therapeutic approaches, and disease progression. This heterogeneity stems from multiple factors: (1) Differences in immune targets: MS primarily involves T-cell-mediated myelin attack, NMOSD is mainly driven by astrocyte damage caused by anti-AQP4 antibodies, MOGAD results from myelin surface loss mediated by antibodies against myelin oligodendrocyte glycoprotein immunoglobulin G, while AE involves synaptic dysfunction due to antibodies against neuronal surface proteins (e.g., anti-NMDA-R antibodies); (2) Genetic-environmental interactions: MS is more prevalent in European and American populations, whereas NMOSD is more aggressive in Asian populations; (3) Variability in treatment response: Some diseases respond well to immunomodulatory therapy, but most still face challenges such as high relapse rates, progressive disability accumulation, and irreversible neurological damage.\n\nWhile randomized controlled trials (RCTs) provide high-quality core evidence for drug registration, their strict inclusion\u002Fexclusion criteria, relatively homogeneous patient populations, and short-term observation designs often fail to fully capture the complex disease progression and treatment response patterns in real-world clinical settings. Additionally, long-term RCTs are frequently constrained by economic factors and sustainability challenges. Therefore, conducting comprehensive real-world observational studies (RWS) on NADs-integrating multi-disease cohorts, long-term follow-up data, and diverse clinical practices-holds significant scientific and clinical value for optimizing treatment strategies and improving long-term patient outcomes.",[27,227,28,228,229,230,231,29,232],"NMO Spectrum Disorder","Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease","Autoimmune Nodopathy","Acute Inflammatory Demyelinating Polyradiculoneuropathy","Chronic Inflammatory Demyelinating Polyradiculoneuropathy","Idiopathic Inflammatory Myopathies","NOT_YET_RECRUITING","2026-01-17",{"date":236,"type":42},"2026-01-21",{"date":238,"type":22},"2026-03-01",{"date":240,"type":22},"2037-03-01",{"name":242,"class":49},"Tongji Hospital",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":63,"phases":253,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":4},"100619223","phase-1-a-study-of-c-car168-in-the-treatment-of-central-nervous-system-autoimmune-diseases-refractory-to-standard-therapy-100619223","NCT07341828","A Study of C-CAR168 in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy","An Exploratory Clinical Study of Anti-CD20\u002FB-cell Maturation Antigen(BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy","Inclusion Criteria:\n\n* 18 to 70 years old at the time of signing the Informed Consent Form (ICF).\n* Diagnosed as Multiple Sclerosis (MS)\u002FNeuromyelitis Optica Spectrum Disorders (NMOSD)\u002FAutoimmune Encephalitis(AiE)\u002FStiff Person Spectrum Disorder(SPSD) according to recognized diagnostic criteria for at least 6 months.\n* Prior treatment failure with standard therapy.\n* Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.\n\nExclusion Criteria:\n\n* Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive.\n* Uncontrolled active infection.\n* Live vaccine injection within 4 weeks prior to signing the ICF.\n* Major organ transplantation history or bone marrow\u002Fhematopoietic stem cell transplantation history.\n* Severe cardiovascular diseases within the past 6 months prior to screening.\n* A history of ≥ Grade 2 bleeding within 4 weeks prior to screening, or requiring long-term anticoagulants treatment.\n* Inadequate washing time for previous treatment.\n* Previously treated with CAR-T cell products or genetically modified T cell therapies.\n* Pregnant or lactating women.\n* Severe central nervous system diseases or pathological changes.\n* Malignancy history within 5 years prior to signing the ICF.\n* Any contraindication to lumbar puncture.","70 Years",{"count":252,"type":22},15,[254],"PHASE1","This is an investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with central nervous system autoimmune diseases refractory to standard therapy",[257,26,28,258],"Multiple Sclerosis (MS)","Stiff Person Syndrome",[260],"CD20\u002FBCMA-directed CAR-T cells","2026-01-13",{"date":263,"type":42},"2026-01-15",{"date":265,"type":22},"2026-02",{"date":267,"type":22},"2029-02",{"name":269,"class":49},"Huashan Hospital",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":63,"phases":279,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":50},"100588266","early-phase-1-universal-chimeric-antigen-receptor-t-cell-ucar-t-cell-therapy-targeting-cd19b-cell-maturation-antigen-cd19bcma-in-patients-with-rr-neurological-autoimmune-diseases-100588266","NCT06939166","Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19\u002FB Cell Maturation Antigen （CD19\u002FBCMA） in Patients With r\u002Fr Neurological Autoimmune Diseases","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapsed \u002F Refractory Neurological Autoimmune Diseases","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.\n* Subjects with relapsed or refractory neurological autoimmune diseases, Including neuromyelitis optica spectrum disorders(NMOSD), myasthenia gravis(MG), multiple sclerosis(MS)，Autoimmune encephalitis(AE) and chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP).\n* Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.\n* Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Subjects with a history of severe drug allergies or allergic tendencies.\n* History of malignancy within five years.\n* Subjects with insufficient cardiac function.\n* Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \\>the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.\n* Pregnant women or women planning to conceive.",{"count":278,"type":22},12,[280],"EARLY_PHASE1","This is an open label, single-site, dose-escalation study in up to 12 participants with relapsed or refractory Neurological Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with universal CD19\u002FBCMA CAR T-cells.",[283,29,27,231,28],"Neuromyelitis Optica Spectrum Disorders",[285],"Universal Allogeneic CAR T-cells","2025-12-11",{"date":288,"type":42},"2025-12-15",{"date":290,"type":42},"2025-06-17",{"date":292,"type":22},"2027-10",{"name":294,"class":49},"Tianjin Huanhu Hospital",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":63,"phases":305,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":324},"100361984","phase-2-trial-to-evaluate-efficacy-and-safety-of-bortezomib-in-patients-with-severe-autoimmune-encephalitis-100361984","NCT03993262","Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis","A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis","Generate-Boost","Inclusion Criteria:\n\n* Clinically diagnosed severe autoimmune encephalitis (defined as mRS ≥ 3) with autoantibodies to neuronal surface proteins in cerebrospinal fluid and \u002F or serum\n* Pretreatment with rituximab\n* Age ≥18 years\n* signed informed consent\n* Women of childbearing potential (up to 2 years after menopause): negative pregnancy test\n\nExclusion Criteria:\n\n* pregnancy\u002Fbreast-feeding\n* acute infiltrative pulmonary and pericardial disease\n* malignant tumor under current chemotherapy\n* Simultaneous participation in another intervention study\n* Previous participation in this study\n* Known hypersensitivity to an ingredient of the investigational product\n* Continued therapy with glucocorticoids \u002F rituximab during the study duration (last dose must be administered before the first dose of the investigational product)",{"count":304,"type":22},50,[65],"Autoimmune Encephalitis is a disorder of the central nervous system caused by bodily substances, called antibodies. Antibodies normally help the body to prevent infections. However, in this disorder, the antibodies turn against the body itself and especially against cells in the brain and disturb the normal brain function. They are therefore called autoantibodies.\n\nThere is no specific therapy for patients with autoimmune encephalitis so far. At the moment, the symptoms are treated with approved medications such as cortisone and immunotherapies also used in oncology. These therapies are unspecified and aim to reduce the number of autoantibodies and to contain the autoimmune process. In this trial we aim to test a new therapy option: in this therapy the body cells producing autoantibodies will be specifically targeted by a substance called bortezomib.\n\nThe trial addresses patients with severe autoimmune encephalitis. The aim of the trial is to evaluate the efficacy and safety of bortezomib in patients with severe autoimmune encephalitis.",[28],[309,310,311,312,313,314],"autoimmune disease","autoimmune encephalitis","bortezomib","NMDAR","LGI1","encephalitis","2025-08-27",{"date":317,"type":42},"2025-09-04",{"date":319,"type":42},"2020-05-13",{"date":321,"type":22},"2026-12-31",{"name":323,"class":49},"Jena University Hospital",17,{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":63,"phases":335,"briefSummary":337,"conditions":338,"keywords":339,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":50},"100522182","impact-of-confirmed-autoimmune-encephalitis-on-brain-glucose-metabolism-100522182","NCT06079294","Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism","Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism : a Prospective FDG PET Study","ENCEPHATAIP","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Newly diagnosed autoimmune encephalitis based on at least 1 of the 3 following criteria :\n\n  1. \" Definite limbic autoimmune encephalitis \" according to 2016 Graus et al. criteria\n  2. \" Possible autoimmune encephalitis \" according to 2016 Graus et al. criteria AND typical autoantibody detected in serum or CSF\n  3. \" Probable or certain paraneoplastic neurological syndrome \" according to Graus et al. 2021 criteria (excluding peripheral neurological syndromes)\n* Less than 6 months since first neurological symptoms imputable to autoimmune encephalitis\n* Affiliated or entitled to a social security system (except AME)\n* Obtaining free, written and informed consent (patient or legal representative or the close relative)\n\nExclusion criteria\n\n* History of brain tumor, head trauma, infarction or cerebral hematoma likely to result in altered cerebral carbohydrate metabolism on PET\n* Patients who hae been on immunotherapy (corticosteroid bolus, IVIg, plasma exchange, endoxan, rituximab or other immunotherapy) fr more than 10 days\n* Pregnant or breast-feeding woman\n* Ventilated intubated patient\n* Absolute contraindication to MRI (Pacemaker, cochlear implant, etc.)\n* Presence of cognitive disorders incompatible with goog cooperation with the PET scan\n* Algic or agitated patient unable to remain immobile in supine position for 30 minutes\n* Deprived of liberty or under a protective measure (guardianship or curatorship)\n* Patient taking part in other interventional research involving radiopharmaceutical injections",{"count":334,"type":22},56,[336],"NA","Prospective cohort study evaluating FDG PET in 56 patients with confirmed autoimmune encephalitis - based on 2016 Graus criteria, and 2021 paraneoplastic neurological syndromes criteria - at the acute phase, before immunomodulating treatment, or within 10 days of treatment initiation.",[28],[28,340,341,342,313,343,344],"PET","FDG","NMDAr","CASPR2","GAD","2025-08-21",{"date":347,"type":42},"2025-08-22",{"date":349,"type":42},"2024-05-31",{"date":351,"type":22},"2026-05-31",{"name":353,"class":49},"Assistance Publique - Hôpitaux de Paris",{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":361,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":50},"100529384","a-prospective-study-to-evaluate-clinical-outcomes-in-anti-lgi1-encephalitis-100529384","NCT06173076","A Prospective Study to Evaluate Clinical Outcomes in Anti-LGI1 Encephalitis","A Prospective Study to Evaluate Clinical Outcomes in Patients With Anti-leucine-rich Glioma-inactivated 1 Encephalitis","Inclusion Criteria:\n\n1. Meet the 2016 consensus diagnostic criteria for anti-LGI1 encephalitis.\n2. Newly diagnosed, and during the acute stage before study enrollment.\n3. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. with the diagnosis of epilepsy, stroke, cerebral trauma, and\u002For other nervous system disease prior to the onset of encephalitis.\n2. with coexisting antibodies, such as anti-contactin-associated protein 2 (CASPR2) antibody.\n3. Lost to follow-up.","100 Years",{"count":363,"type":22},60,"Anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis has been increasingly identified as the second most common type of autoimmune encephalitis after anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis. It presents with acute or subacute onset of epileptic seizures, anterograde amnesia, behavior disturbances, sleep disorders and hyponatremia. In most patients with anti-LGI1 encephalitis, immunotherapy is successful in treating the encephalitis. However, relapses, chronic epilepsy, cognitive declines and psychiatric problems have been reported in some cases.\n\nSo far, prospective studies to evaluate its clinical outcomes still remain limited. In this project, the investigators will use clinical features and advanced paraclinical examinations to prospectively investigate the clinical outcomes and the associated factors in patients with anti-LGI1 encephalitis.",[28,366],"Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis","2025-08-20",{"date":315,"type":42},{"date":370,"type":42},"2022-05-18",{"date":372,"type":22},"2032-12-31",{"name":374,"class":49},"Shen Chun-Hong",{"id":376,"slug":377,"hasResults":11,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":383,"targetDuration":4,"studyType":63,"phases":385,"briefSummary":386,"conditions":387,"keywords":388,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":4},"100603066","phase-1-huc-msc-exo-therapy-for-autoimmune-encephalitis-100603066","NCT07131683","hUC-MSC-Exo Therapy for Autoimmune Encephalitis","Human Umbilical Cord Mesenchymal Stem Cell-derived ExoSomes for Autoimmune Encephalitis: a Phase I\u002FIIa Clinical Trial (MESAE)","MESAE","Inclusion Criteria:\n\n1. Aged 18-65 years, both male and female are eligible;\n2. Diagnosis of autoimmune encephalitis within 3 months of onset (meeting the 2016 Graus and Dalmau diagnostic criteria), with positive serum\u002Fcerebrospinal fluid anti-NMDAR antibodies or anti-LGI1 antibodies;\n3. Modified Rankin Scale (mRS) score ≥ 2 at enrollment;\n4. The subject or legally authorized representative is able to sign the informed consent form;\n5. Subjects of childbearing potential must agree to practice strict contraception during the study period.\n\nExclusion Criteria:\n\n1. Pre-morbid modified Rankin Scale (mRS) score ≥ 2;\n2. Known allergy to any component of the investigational product or history of severe allergic reactions;\n3. Presence of neurological or psychiatric disorders (e.g., cerebrovascular disease, Parkinson's disease, severe depression) deemed by the investigator to potentially impair trial participation or study assessments;\n4. Current or history of any clinically significant systemic diseases judged by the investigator as unsuitable for inclusion, including but not limited to:\n\n   * Severe cardiovascular diseases (e.g., congestive heart failure, severe arrhythmia, myocardial infarction)\n   * Hepatic diseases (e.g., cirrhosis)\n   * Renal diseases (e.g., requiring hemodialysis or peritoneal dialysis)\n   * Hematological diseases (e.g., hemophilia with bleeding tendency)\n   * Endocrine disorders (e.g., poorly controlled diabetes with blood glucose \\>16.8 mmol\u002FL or \\\u003C2.8 mmol\u002FL, or with severe complications)\n   * Immune system disorders (active or uncontrolled systemic autoimmune diseases, primary\u002Fsecondary immunodeficiency)\n   * Malignancies;\n5. Anatomical nasal abnormalities, nasal mucosal damage, severe rhinitis, or other nasal conditions affecting drug administration;\n6. Requiring nasogastric tube placement;\n7. Organ function meeting any of the following criteria:\n\n   1. Absolute neutrophil count (ANC) \\\u003C1.5×10⁹\u002FL, platelets (PLT) \\\u003C100×10⁹\u002FL, hemoglobin (Hb) \\\u003C90 g\u002FL\n   2. Aspartate aminotransferase (AST) \\>2.5×ULN and\u002For alanine aminotransferase (ALT) \\>2.5×ULN, total bilirubin (TBIL) \\>1.5×ULN\n   3. Creatinine \\>1.5×ULN\n   4. Without anticoagulant\u002Fantiplatelet therapy: International normalized ratio (INR) \\>1.7 or activated partial thromboplastin time (APTT) \\>1.25×ULN With anticoagulant\u002Fantiplatelet therapy: INR \\>3.0 or APTT \\>1.5×ULN;\n8. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable HBV-DNA; or positive for hepatitis C antibody (HCVAb), Treponema pallidum antibody (TPAb\u002FRPR), or human immunodeficiency virus antibody (HIV);\n9. Pregnant or lactating patients;\n10. Contraindications for MRI (e.g., metal implants such as pacemakers, claustrophobia);\n11. Participation in any clinical trial involving investigational drugs within 3 months prior to dosing (or within 5 half-lives of last dose, whichever is longer);\n12. Major trauma or surgery within 3 months prior to dosing, or planned surgery during the trial (excluding laparoscopy or minor procedures \\>4 weeks before baseline; excluding thymoma\u002Fteratoma surgery);\n13. History of drug abuse or alcoholism within 1 year prior to dosing;\n14. Previous treatment with stem cells or derivatives;\n15. Any other condition that may increase patient risk or interfere with result interpretation, as determined by the investigator.",{"count":384,"type":22},38,[254,65],"This is a phase I\u002FIIa study to investigate the safety and preliminary efficacy of intranasal admnistration of human umbilical mesenchymal stem cell-derived exosome (hUC-MSC-Exo) for patients with autoimmune encephalitis.",[28],[389,390,310,391,392],"mesenchymal stem cell","exosome","safety","efficacy","2025-08-19",{"date":367,"type":42},{"date":396,"type":22},"2025-11-01",{"date":398,"type":22},"2027-08-31",{"name":400,"class":49},"Xuanwu Hospital, Beijing",{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":58,"minAge":409,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":63,"phases":412,"briefSummary":413,"conditions":414,"keywords":415,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":428},"100391102","phase-2-the-extinguish-trial-of-inebilizumab-in-nmdar-encephalitis-100391102","NCT04372615","The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis","A Phase-2b, Double-Blind, Randomized Controlled Trial to Evaluate the Activity and Safety of Inebilizumab in Anti-Nmda Receptor Encephalitis and Assess Markers of Disease","ExTINGUISH","Inclusion Criteria\n\n1. Diagnosis of NMDAR encephalitis, defined by both a and b:\n\n   1. A subacute onset of change in mental status consistent with autoimmune encephalitis,\n   2. A positive cell-based assay for anti-NMDA receptor IgG antibody in the CSF confirmed in study-specified laboratories.\n2. Participants, ≥ 12 years of age at the time of informed consent. Participants under 18 years of age must weigh ≥40 kilograms.\n3. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act \\[HIPAA\\] in the United States of America \\[USA\\], European Union \\[EU\\] Data Privacy Directive in the EU) obtained from the participant\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n4. Non-sterilized participants who are sexually active with a partner capable of becoming pregnant must use a condom with spermicide from Day 1 through to the end of the study and must agree to continue using such precautions for at least 6 months after the final dose of IP. A recommendation will be made that the partners (capable of becoming pregnant) of study participants (capable of getting their partner pregnant) should use a highly effective method of contraception other than a physical method.\n\n   Participants of childbearing potential who are sexually active with a non-sterilized partner capable of getting their partner pregnant must agree to use a highly effective method of contraception beginning at screening or upon discharge from hospitalization\u002Finpatient rehabilitation (for participants who were incapacitated at the time of screening), and to continue precautions for 12 months after the final dose of IP.\n   1. Participants of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are not postmenopausal (per ICH M3 (R2) 11.2: defined as 12 months with no menses without an alternative medical cause).\n   2. A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Periodic abstinence, the rhythm method, and the withdrawal method do not qualify as \"highly effective\" or acceptable methods of contraception for study purposes. Acceptable methods of contraception are listed in the table below:\n\n      Physical Methods Hormonal Methods e\n\n      • Intrauterine device (IUD)\n\n      • Intrauterine hormone-releasing system, also known as drug-eluting IUD a\n\n      • Bilateral tubal occlusion\n\n      • Vasectomized partner b\n\n      • Sexual abstinence c • Combined (estrogen and progestogen-containing hormonal contraception)\n      * Oral (combined pill)\n      * Injectable\n      * Transdermal (patch)\n      * Progestogen-only hormonal contraception associated with inhibition of ovulation d\n      * Implantable\n      * Intravaginal a This is also considered to be a hormonal method. b With appropriate post-vasectomy documentation of surgical success (absence of sperm in ejaculate).\n\n      c Sexual abstinence is considered to be a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of the study and if it is the preferred and usual lifestyle of the participant.\n\n      d Progestogen-only hormonal contraception, where inhibition of ovulation is not the primary mode of action (minipill) is not accepted as a highly effective method.\n\n      e These methods are only considered highly effective and therefore acceptable when used in conjunction with a barrier method (i.e., diaphragm with spermicide, sponge with spermicide, cervical cap with spermicide, condoms, spermicide alone.)\n5. Willing to forgo other immunomodulatory therapies (investigational or otherwise) for NMDAR encephalitis during the study.\n6. Participant must have received at least 3 days of methylprednisolone 1000 mg IV or equivalent corticosteroid within 90 days prior to randomization (Day 1). In addition, participants must have received EITHER of the following treatments within 90 days before randomization.\n\n   1. IVIg, at a dose range between 1.2 and 2 g\u002Fkg\n   2. Plasma exchange or plasmapheresis, (defined as 5 to 6 exchanges).\n\n   NOTE: These treatments may be provided during the screening period but must be completed prior to randomization. Participants who receive methylprednisolone and BOTH IVIg and plasma exchange are not excluded from participating in the trial, however, this treatment course with both IVIg and plasma exchange is not encouraged, and enrollment and randomization should not be delayed in order to complete additional first line treatments.\n7. Modified Rankin Score of ≥3 at the screening visit, indicating at least moderate disability. The baseline mRS must be confirmed by Site Investigators at screening and confirmed \u002F adjudicated before randomization.\n8. Ability and willingness to attend study visits and complete the study. \\*All inclusion criteria must be met during the screening period, prior to randomization, except where noted.\n\nExclusion Criteria\n\nAny of the following excludes an individual from participation in the study:\n\n1. Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the IP, interpretation of participant safety or study results, or would make participation in the study an unacceptable risk. This specifically includes recent history (last 5 years) of herpes simplex virus encephalitis or known central nervous system demyelinating disease (e.g., multiple sclerosis).\n2. Presence of an active or chronic infection that is serious in the opinion of the Investigator.\n3. History of solid organ or cell-based transplantation.\n\n\u003C!-- -->\n\n1. Concurrent\u002Fprevious enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is longer, prior to randomization.\n2. Lactating or pregnant individuals, or individuals who intend to become pregnant anytime from study enrollment to 12 months following last dose of investigational agent.\n3. Known history of allergy or reaction to any component of the investigational agent formulation or history of anaphylaxis following any biologic therapy.\n4. Receipt of the following at any time prior to randomization:\n\n   a. Alemtuzumab b. Total lymphoid irradiation c. Bone marrow transplant d. T-cell vaccination therapy\n5. Receipt of any biologic B cell-depleting therapy (e.g., rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) in the 6 months prior to screening. Receipt of such a B cell-depleting agent in the period 6-12 months prior to screening is exclusionary unless B cell counts have returned to ≥ age-based LLN by central laboratory. For EU participants, B cell counts at screening will be determined by the laboratories of the participating sites. Receipt of non-depleting B cell-directed therapy (e.g., belimumab), abatacept, or other biologic immunomodulatory agent within 6 months prior screening.\n6. Treatment at therapeutic doses\u002Fdurations with any of the following within 3 months prior to randomization\n\n   a. Natalizumab (Tysabri®) b. Cyclosporine c. Methotrexate d. Mitoxantrone e. Cyclophosphamide\\* f. Azathioprine g. Mycophenolate mofetil\n\n   \\*Cyclophosphamide is only permitted as rescue therapy to be administered as outlined in Section 5.4.1 no earlier than the week 6 visit.\n7. Severe drug allergic history or anaphylaxis to two or more food products or medicines (including known sensitivity to acetaminophen\u002Fparacetamol, diphenhydramine (cetirizine in EU) or equivalent antihistamine, and methylprednisolone or equivalent glucocorticoid).\n8. Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection or splenectomy that predisposes the participant to infection.\n9. Active malignancy or history of malignancy that was active within the last 10 years, apart from ovarian or extra-ovarian teratoma (also known as a dermoid cyst) or germ cell tumor, or squamous cell carcinoma of the skin or basal cell carcinoma of the skin, that in the opinion of the Medical Safety Monitor (MSM) would preclude enrollment due to safety concerns. Squamous cell and basal cell carcinomas should be treated with documented success of curative therapy \\> 3 months prior to randomization.\n10. At screening (repeat testing may be conducted to confirm results within the same screening period, prior to randomization), any of the following:\n\n    a. Total white blood count \\\u003C2,500 cells\u002Fmm3 (or \\\u003C 2.5 × 109\u002FL) b. Total immunoglobulin \\\u003C 600 mg\u002FdL (or 6 µmol\u002FL; 400 mg\u002FdL for participants \\\u003C18 years)\\* c. Absolute neutrophil count \\\u003C 1200 cells\u002FμL (or \\\u003C 1.2 × 109\u002FL) d. CD4 T lymphocyte count \\\u003C 300 cells\u002FµL (or \\\u003C 0.3 × 109\u002FL)\n\n    \\*Baseline levels of IgG prior to first line treatments (methylprednisolone, plasmapheresis\u002Fplasma exchange) should be used to determine eligibility.\n11. Active hepatitis B or C established with positive hepatitis B serology (hepatitis B surface antigen and core antigen) and\u002For positive hepatitis C PCR testing and confirmed by the MSM\n12. Any live or attenuated vaccine within 4 weeks prior to Day 1 (administration of killed vaccines is acceptable).\n13. Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of enrollment.\n14. History of alcohol or drug abuse that, in the opinion of the Investigator, might affect participant safety or compliance with visits or interfere with safety or other study assessments.\n15. Recurrence of previously treated NMDAR encephalitis within the last 5 years, or suspicion of symptomatic untreated NMDAR encephalitis of greater than 3 months duration at the time of screening.\n16. Evidence of active tuberculosis\\* (TB) or being at high risk for TB based on:\n\n    a. History of active TB or untreated\u002Fincompletely treated latent TB. Participants with a history of active or latent TB who have documentation of completion of treatment according to local guidelines may be enrolled.\n\n    b. History of recent (≤ 12 weeks of screening) close contact with someone with active TB (close contact is defined as ≥ 4 hours\u002Fweek OR living in the same household OR in a house where a person with active TB is a frequent visitor).\n\n    c. Signs or symptoms that could represent active TB by medical history or physical examination.\n\n    d. Positive, indeterminate, or invalid interferon-gamma release assay test result at screening, unless previously treated for TB. Participants with an indeterminate test result can repeat the test once, but if the repeat test is also indeterminate, the participant is excluded.\n\n    e. Chest radiograph, chest computed tomography or MRI scan that suggests a possible diagnosis of TB or suggests that a work-up for TB should be considered; all participants must have had lung imaging with an acceptable reading within 6 months prior to consent, or during screening.\n17. Active, clinically significant (CS) infection at the time of randomization (IP administration may be delayed until recovery, if within 14-day screening window, otherwise participant may be rescreened).\n\nExclusion criteria are applied at time of screening and are applicable throughout the study.\n\n* Participants will undergo QuantiFERON®-TB Gold testing or equivalent TB testing during screening as standard of care. A positive result will not exclude patients from participation; thus, enrollment should not be delayed awaiting this result. If positive, an appropriate course of anti-TB treatment will need to be documented. If results are in indeterminate, participants may still be eligible for randomization if history is not suggestive of active \u002F latent TB and a chest x-ray shows no evidence of active or latent TB.\n\n1.1 Additional Eligibility Considerations\n\nThe following criteria are not necessarily exclusionary but require review from the MSM to determine if a participant should be excluded due to safety concerns:\n\n1. At screening (out of range lab values may be reviewed with the MSM to determine whether a potential participant should be excluded for safety reasons; repeat testing may be conducted to confirm results within the same screening period, prior to randomization), any of the following:\n\n   1. Aspartate transaminase (AST) \\> 2.5 × age-based upper limit of normal (ULN)\n   2. Alanine transaminase (ALT) \\> 2.5 × age-based ULN\n   3. Total bilirubin \\> 1.5 × age-based ULN (unless due to Gilbert's syndrome)\n   4. Platelet count \\\u003C 75,000\u002FμL (or \\\u003C 75 × 109\u002FL)\n   5. Hemoglobin \\\u003C 8 g\u002FdL (or \\\u003C 80 g\u002FL or 5 mmol\u002FL)\n2. History of untreated hepatitis C infection. Participants who are considered cured following antiviral therapy with an HCV load below the limit of detection may be enrolled pending confirmation from the MSM that there are no safety concerns for inclusion.\n3. Patients with coexistent autoantibodies should not immediately be excluded but should be reviewed with the MSM to determine eligibility.","12 Years",{"count":411,"type":22},116,[65],"Determine the difference in the modified Rankin score at 16 weeks in participants with anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis treated with \"first-line\" immunomodulatory therapies provided as standard-of-care, and either inebilizumab (investigational agent) or placebo.",[28,72],[416,417,28,418],"Inebilizumab","NMDAR encephalitis","Rare Disease","2025-06-30",{"date":421,"type":42},"2025-07-01",{"date":423,"type":42},"2022-03-30",{"date":425,"type":22},"2028-09-30",{"name":427,"class":49},"University of Utah",39,{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":16,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":63,"phases":438,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":50},"100560968","efficacy-and-safety-of-calculus-bovis-sativus-cbs-for-adult-encephalitis-cbsinencephalitis-100560968","NCT06584045","Efficacy and Safety of Calculus Bovis Sativus (CBS) for Adult Encephalitis (CBSinEncephalitis)","An Open Label Clinical Trial to Evaluate the Efficacy and Safety of Calculus Bovis Sativus (CBS) for Adult Encephalitis","Inclusion Criteria:\n\n* Subjects must meet the following eligibility criteria at screening to participate in this study.\n\n1.1 Inclusion criteria for subjects with autoimmune encephalitis (hereinafter referred to as AE) of all subtypes 1.1.1 Subjects are able to understand the purpose and risks of the study, provide informed consent, and authorize the use of confidential health information in accordance with national and local privacy regulations.\n\n1.1.2. Tumors or malignancies can be reasonably excluded before the baseline visit (randomization), and screening guidelines for thymoma, teratoma, and malignant tumors should be followed.\n\n1.1.3. Both men and women are welcome, and the age at the time of providing informed consent is 18-80 years old (inclusive).\n\n1.1.4. Meet the diagnosis of AE (according to the Chinese Autoimmune Encephalitis Diagnosis and Treatment Expert Consensus 2022 Edition): A. Clinical manifestations: acute or subacute onset (\\\u003C3 months), with one or more of the following neurological and psychiatric symptoms or clinical syndromes.\n\n* a. Limbic system symptoms: recent memory loss, epileptic seizures, mental and behavioral abnormalities, one or more of the three symptoms.\n* b. Encephalitis syndrome: clinical manifestations of diffuse or multifocal brain damage.\n* c. Clinical manifestations of involvement of the basal ganglia and\u002For diencephalon\u002Fhypothalamus.\n* d. Mental disorder, and the psychiatric specialist believes that it does not meet the non-organic disease.\n\nB. Auxiliary examination: one or more of the following auxiliary examination findings, or combined with related tumors.\n\n* a. Abnormal cerebrospinal fluid: cerebrospinal fluid leukocytosis (\\>5×106\u002FL), or cerebrospinal fluid cytology shows lymphocytic inflammation, or specific oligoclonal bands are positive.\n* b. Neuroimaging or electrophysiological abnormalities: MRI limbic system T2 or FLAIR abnormal signals, unilateral or bilateral, or other areas of T2 or FLAIR abnormal signals (excluding nonspecific white matter changes and stroke); or PET imaging limbic system hypermetabolism changes, or multiple cortical and\u002For basal ganglia hypermetabolism. Figure 1 shows the typical neuroimaging manifestations of AE patients. Abnormal electroencephalogram, manifested as focal epilepsy or epileptiform discharge (located in the temporal lobe or outside the temporal lobe), or diffuse or multifocal slow wave rhythm. In adult patients with anti-NMDAR encephalitis, abnormal delta brush waves (extreme delta brush) often correspond to prolonged hospitalization and poor prognosis.\n* c. Specific types of tumors associated with AE, such as limbic encephalitis combined with small cell lung cancer, anti-NMDAR encephalitis combined with ovarian teratoma.\n\nC. Confirmatory experiments: positive anti-neuronal antibodies. Including NMDA-R, LGI-1, CASPR2, IgLON5, GABAA\u002FBR, GlyR, AMPAR and axonal protein-3α and intracellular substance antibodies anti-Hu, anti-Ma2, anti-CRMP5, anti-Yo, anti-double carrier protein, anti-GAD, etc.\n\nD. Reasonably exclude other causes (refer to the differential diagnosis section of the consensus).\n\nDiagnostic criteria: including possible AEs and confirmed AEs:\n\n1. Possible AEs: meet the three diagnostic criteria of A, B and D.\n2. Confirmed AEs: meet the four diagnostic criteria of A, B, C and D. 1.1.5. AE symptoms occurred ≤9 months before randomization 1.1.6. Subjects meet new AEs\n\n   \\- New onset: defined as subjects with NMDA-R or LGI-1 AEs and meeting the following criteria:\n   * The mRS score measured at baseline is stable (at least 24 hours) and is ≥2 points.\n   * Received the first acute first-line treatment within 6 weeks before randomization (baseline visit).\n\n   1.1.7. All females of childbearing potential and all males must use contraception during the study and for at least 30 days after the last dose of study treatment. In addition, subjects should not donate sperm or eggs during the study and for at least 30 days after the last dose of study treatment.\n\n   1.1.8. Stable neurological examination within 30 days before baseline (Visit 1).\n\n   1.2 Additional inclusion criteria for the NMDA-R AE cohort\n\n   In addition to the criteria outlined in Section 1.1, only subjects who met all of the following criteria were eligible for inclusion in the NMDA-R AE cohort:\n   * Age ≥ 18 years at the time of informed consent\n   * Informed consent, as appropriate based on patient age, specific site, and national criteria\n   * Suspected or definite NMDAR AE diagnosis as follows:\n\n   1.2.1. Suspected NMDAR encephalitis was diagnosed when all three of the following criteria were met: 1.2.1.1 Rapid onset (less than 3 months) of at least four of the following six cardinal symptoms:\n   * Abnormal (psychiatric) behavior or cognitive dysfunction\n   * Speech dysfunction (rushing speech, hypospeech, mutism)\n   * Seizures\n   * Ataxia, dyskinesia, or rigid\u002Fabnormal posture\n   * Decreased level of consciousness\n   * Autonomic dysfunction or central hypoventilation 1.2.1.2. At least one of the following laboratory results:\n   * Abnormal EEG (focal or diffuse slow or disorganized activity, epileptic activity, or extreme delta brushes)\n   * CSF with pleocytosis or oligoclonal bands 1.2.1.3. Reasonable exclusion of other etiologies and other clear encephalitis syndromes: for example, Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis, Hashimoto encephalopathy, primary angiitis of the central nervous system (CNS), Rasmussen encephalitis.\n\n   Note: If the above three groups of symptoms in criterion 1.2.1.1 are present and accompanied by systemic teratoma, suspected NMDAR encephalitis can also be diagnosed.\n\n   1.2.2 Definite NMDAR encephalitis can be diagnosed when the following three criteria are met at the same time: 1.2.2.1. The presence of one or more of the six main symptoms described in criterion 1.2.1.1 for suspected NMDAR encephalitis.\n\n   1.2.2.2. History of anti-NMDAR (GluN1) IgG antibodies detected in CSF using a cell-based assay.\n\n   1.2.3. Reasonable exclusion of other etiologies and other well-defined encephalitis syndromes: e.g., Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis, Hashimoto encephalopathy, primary angiitis of the central nervous system (CNS), Rasmussen encephalitis.\n\n   1.3 Other inclusion criteria for the LGI-1 AE cohort\n\n   In addition to the criteria outlined in Section 1.1, only subjects who meet all of the following criteria are eligible for inclusion in the LGI1 AE cohort:\n\n   1.3.1 Age ≥ 18 years at the time of signing the informed consent For subjects who are unable to provide informed consent due to the severity of their illness, the informed consent may be signed by their legally authorized representative at the time of obtaining the subject's consent, according to local requirements.\n\n   1.3.2 Diagnosis of LGI-1 AE\n\n   The diagnosis of LGI-1 encephalitis can be made when both of the following criteria are met:\n\n   1.3.2.1 Documented history of anti-LGI-1 IgG antibodies (in serum or CSF) using a cell-based assay.\n\n   1.3.2.2 Subacute onset (less than 4 months of development) of working memory deficits, seizures (including faciobrachial dystonic seizures), or psychiatric symptoms suggestive of limbic system involvement.\n\n   1.3.2.3 Diagnosis of LGI1 AE is reasonable when other etiologies and other well-defined encephalitis syndromes are excluded: e.g., Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis, Hashimoto encephalopathy, primary CNS vasculitis, Rasmussen encephalitis.\n\n   1.4 Other inclusion criteria for the AA AE cohort\n\n   In addition to the criteria outlined in Section 1.1, only subjects who meet all of the following criteria are eligible for inclusion in the AA AE cohort:\n   * Aged ≥ 18 years at the time of signing the informed consent form For subjects who are unable to provide informed consent due to the severity of their illness, the informed consent form may be signed by their legally authorized representative when the subject agrees, according to local requirements.\n   * Diagnosis of AA AE Meet the diagnosis of AE in 1.1, negative for anti-NMDA antibodies and anti-LGI-1 antibodies, and positive for at least one of the other anti-neuronal antibodies.\n\n   1.5 Inclusion criteria for viral encephalitis (hereinafter referred to as VE) cohort\n\n   The following four conditions must be met simultaneously for diagnosis of VE:\n   * Primary condition: altered mental status, including decreased level of consciousness, drowsiness, or abnormal mental behavior lasting ≥24 h; or new onset of epileptic seizure\n   * Secondary condition: fever ≥38 °C (before or within 72 h after onset), or new focal manifestations of the nervous system, or cerebrospinal fluid leukocytes ≥5×10\\^6\u002FL, or cerebrospinal fluid cytology showing lymphocytic inflammation, or imaging showing brain parenchymal lesions consistent with encephalitis, or abnormal electroencephalogram consistent with encephalitis\n   * Confirmatory laboratory test: positive cerebrospinal fluid viral nucleic acid (polymerase chain reaction or metagenomic next-generation sequencing), or positive cerebrospinal fluid and\u002For serum antiviral antibody IgM\n   * Reasonable exclusion of other causes\n\n   1.6 Healthy cohort:\n   * Age ≥ 18 years old when signing the informed consent form\n   * Healthy adult subjects without underlying diseases\n\n     * Exclusion Criteria:\n\n       * Any clinically significant cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, and renal disease or other major medical history that the investigator determines would preclude participation in the clinical trial.\n       * Any untreated teratoma or thymoma at the baseline visit (randomization)\n       * Other causes of symptoms, including central nervous system infection, septic encephalopathy, metabolic encephalopathy, epileptic disorders, mitochondrial disease, Klein-Levin syndrome, Creutzfeldt-Jakob disease, rheumatic disease, Reyes syndrome, or inborn errors of metabolism.\n       * History of herpes simplex encephalitis within the previous 24 weeks. 1.5. Any surgical procedure within 4 weeks prior to baseline, except laparoscopic surgery or minor surgery (defined as surgery requiring only local anesthesia or conscious sedation, i.e., surgery that does not require general, neuraxial, or regional anesthesia and can be performed on an outpatient basis; e.g., toenail surgery, mole surgery, wisdom tooth extraction), excluding thymoma or teratoma removal.\n       * Planned surgery during the study (except minor surgery).\n       * History of severe allergic or anaphylactic reactions, or any allergic reaction that the investigator believes may be exacerbated by any component of study treatment.\n       * Current or history of malignant disease, including solid tumors and hematologic malignancies (except for basal cell carcinoma and squamous cell carcinoma that have been completely resected and considered cured for at least 12 months prior to Day -1). Subjects with cancer remission for more than 5 years prior to baseline (Visit 1) may be included after discussion with the sponsor\u002Fsponsor approval.\n       * A history of gastrointestinal surgery (except appendectomy or cholecystectomy performed more than 6 months before screening), irritable bowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis), or other clinically significant active gastrointestinal diseases in the opinion of the investigator.\n       * A history of clinically significant recurrent or active gastrointestinal symptoms (e.g., nausea, diarrhea, dyspepsia, constipation) within 90 days before screening, including the need to start symptomatic treatment (e.g., start medication for gastroesophageal reflux disease) or a change in symptomatic treatment within 90 days before screening (e.g., dose increase).\n       * A history of diverticulitis or concurrent severe gastrointestinal (GI) abnormalities (e.g., symptomatic diverticular disease) because the investigator believes that this may lead to an increased risk of complications such as GI perforation.\n       * A history of blood donation (1 unit or more), plasma donation, or platelet donation within 90 days before screening.\n       * Active suicidal ideation within 6 months before screening, or a history of suicide attempt within 3 years before screening.\n       * Based on the investigator's judgment, there are serious diseases or abnormalities in the clinical laboratory test results that prevent the patient from completing the study or participating in the study safely.\n       * Pregnant or lactating, or planning to become pregnant during the study or within 3 months after the last dose of the study drug; women of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before the start of the study.\n       * The subject's mental or physical condition will hinder the evaluation of efficacy and safety.\n       * Systolic blood pressure \\>150 mmHg or \\\u003C90 mmHg after sitting still for 5 minutes or before dosing at screening. If out of range, it can be measured again at screening and before dosing. If the repeated measurement value is still out of range, the subject shall not receive the drug.\n       * Subjects with second or third degree atrioventricular block or sick sinus syndrome, poorly controlled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction, or significant ECG abnormalities, including corrected QT interval \\>450 msec (male) or 470 msec (female), where corrected QT interval is determined based on the Fridericia correction method, within 3 months prior to the screening visit.\n       * Planned elective procedures or surgeries at any time after signing the Informed Consent Form by follow-up visit.\n       * Any condition that affects the absorption of study treatment (e.g., gastrectomy).\n       * History of hypersensitivity to heparin or history of heparin-induced thrombocytopenia.\n       * Subjects with abnormalities in medical history, physical examination, ECG, or diagnostic laboratory tests that the investigator considers to be clinically relevant.\n       * History of human immunodeficiency virus (HIV) or positive test results at screening.\n       * Current infection with hepatitis C (defined as positive hepatitis C virus (HCV) antibodies and detectable HCV RNA). Subjects with positive HCV antibodies and HCV RNA below the limit of detection are eligible to participate in the study.\n       * Current infection with hepatitis B (defined as positive HBsAg and\u002For positive total anti-HBc).\n       * Chronic, recurrent, or severe infection (e.g., pneumonia, sepsis) within 90 days prior to baseline (visit 1).\n       * History of tuberculosis (TB) diagnosis or positive latent TB test result.\n       * Symptoms of bacterial, fungal, or viral infection (including upper respiratory tract infection) within 28 days prior to baseline (visit 1). Subjects with localized fungal infection (e.g., candidiasis, tinea) are eligible for rescreening after successful treatment of the infection.\n       * Infection requiring hospitalization or IV anti-infective medication within 4 weeks prior to baseline visit.\n       * Any live or live attenuated vaccine within 28 days prior to baseline (visit 1) or planned during the study.\n       * Contraindications to all of the following salvage therapies: rituximab, intravenous immunoglobulin, high-dose corticosteroids, or IV cyclophosphamide.\n       * History of or receipt of the following treatments: Total lymphoid irradiation, cladribine, T-cell or T Cell recipient vaccination, total body irradiation, or total lymphoid irradiation at any time. Stem cell transplantation at any time.\n       * Abnormal laboratory values determined by the investigator to be clinically significant at Screening or Baseline (Visit 1).\n       * Any of the following blood test abnormalities at Screening: a. White blood cell count \\\u003C 3.0 × 10\\^3\u002FµL. b. Absolute neutrophil count \\\u003C 2.0 × 10\\^3\u002FµL. c. Absolute lymphocyte count \\\u003C 0.5 × 10\\^3\u002FµL. d. Platelet count \\\u003C × 10 × 10\\^4\u002FµL. e. glutamic-pyruvic transaminase, glutamic oxaloacetic transaminase, or γ-glutamyl transpeptidase ≥ 3 x upper limit of normal (ULN) or bilirubin \\> 2 x ULN. f. glomerular filtration rate ≤ 60 mL\u002Fmin\u002F1.73 m2. g. Lymphocyte count \\\u003C lower limit of normal\n       * Any of the following urine test abnormalities at Screening: a. β-2-microglobulin\\>0.3 μg\u002FmL. b. Albumin\u002Fcreatinine ratio\\>22.6 mg\u002Fmmol.\n       * Previous participation in this study.\n       * Blood donation (1 unit or more) within 90 days before screening, plasma donation within 1 week before screening, and platelet donation within 6 weeks before screening.\n       * History of alcohol or drug abuse in the past year (determined by the investigator).\n       * Pregnant or lactating subjects, as well as subjects planning to become pregnant or start breastfeeding at any time during the study and within 30 days after completion of study treatment.\n       * Participating in a clinical trial or having participated in a clinical trial within 90 days before screening.\n       * History of clinically significant suicidal thoughts or behaviors in the past 12 months as assessed by Columbia-Suicide Severity Rating Scale at screening.\n       * Unwilling or unable to comply with protocol requirements.\n       * The patient has obvious hearing or vision impairment, language barriers, claustrophobia, etc., which makes the patient unable to cooperate with the neuropsychological scale assessment and MRI examination.\n       * The researcher or sponsor believes that there are other unknown reasons that make the subject unsuitable for inclusion.",{"count":437,"type":22},250,[336],"Based on the records of traditional Chinese medicine, CBS has the functions of purifying the heart, eliminating phlegm, stimulating bile secretion, and soothing the nerves. It has the ability to alleviate fever, coma, delirium, epilepsy, convulsions in youngsters, dental caries, throat swelling, mouth ulcers, carbuncle, and furuncle.\n\nEncephalitis is a neurological condition characterized by widespread or multiple inflammation of brain tissue. The causes of encephalitis are many and can stem from infectious organisms or be induced by autoimmune reactions, the latter being referred to as autoimmune encephalitis (AE). The yearly occurrence rate of encephalitis is 12.6 per 100,000 individuals. Among these cases, approximately 40-50% are caused by infectious factors, whereas 20-30% are attributed to autoimmune encephalitis (AE). The development of viral encephalitis involves the direct invasion of brain tissue by the virus and the immune response of the body to viral antigens. The virus multiplies extensively, leading to the degeneration of neurons, necrosis, the proliferation of glial cells, and the infiltration of inflammatory cells. These severe tissue reactions can result in the formation of demyelinating lesions and damage to blood vessels and the areas surrounding them. Additionally, vascular lesions affect the circulation in the brain and worsen the damage to brain tissue. The development of AE involves several factors, including molecular mimicry, the activation of latent antigen epitopes, the spread of antigen epitopes, and the disruption of the innate immune system caused by persistent pathogen infection.\n\nThe mechanisms that are clearer can be summarized as follows: (1) Decrease in the number of receptors on the surface due to cross-linking and internalization: Anti-NMDAR antibodies have the ability to attach to NMDAR on the postsynaptic membrane, resulting in a reduction of NMDAR surface density through cross-linking and internalization. This reduction leads to a decrease in NMDAR-mediated current, which in turn causes learning and memory defects. (2) Protein-protein interaction disruption: Anti-LGI1 antibodies can disrupt the binding between LGI1 and ADAM23 on the presynaptic membrane and ADAM22 on the postsynaptic membrane. This disruption leads to a decrease in the density of anti-α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPAR).\n\nAccording to the aforementioned background processes, along with the most recent research, there was a decrease in the abundance of gut flora in patients with AE. Transplanting the fecal bacteria of individuals with anti-NMDAR encephalitis into mice's intestines resulted in cognitive impairment in the animals. This indicates that the brain-gut axis may have a significant role in the development of anti-NMDAR encephalitis. From a clinical perspective, patients consume CBS orally in order to achieve its therapeutic benefits. The primary constituents, bilirubin and bile acid, have been documented to possess regulatory effects on the gut microbiota. Thus, we hypothesize that CBS is probable to have neuroprotective and anti-inflammatory impacts on the brain through alterations in the intestinal microbiota and regulation of the brain-gut connection. CBS is expected to decrease the occurrence of symptomatic seizures and enhance the patient's level of consciousness and cognitive abilities.",[72,441,442,28],"Encephalitis, Viral","Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody","2025-04-06",{"date":445,"type":42},"2025-04-08",{"date":447,"type":42},"2024-09-30",{"date":449,"type":22},"2029-12",{"name":242,"class":49},{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":58,"minAge":4,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":468,"locationsCount":50},"100574500","a-multicentric-cohort-of-autoimmune-encephalitis-100574500","NCT06760091","A Multicentric Cohort of Autoimmune Encephalitis","Multicentric Registry Study of Autoimmune Encephalitis","Inclusion Criteria:\n\n* 1\\. Gender and age are not limited; 2. Newly diagnosed autoimmune encephalitis according to at least one of the following three criteria:\n\n  1. According to the criteria of Graus et al in 2016, diagnosed as \"definite autoimmune limbic encephalitis\"\n  2. According to the criteria of Graus et al in 2016, diagnosed as \"possible autoimmune encephalitis\" and typical autoantibodies are detected in serum or cerebrospinal fluid\n  3. According to the criteria of Graus et al in 2021, diagnosed as \"possible or definite paraneoplastic neurological syndrome\" (excluding peripheral nervous system syndrome) 3. The patient or legal representative voluntarily signed the paper informed consent form.\n\nAdditional inclusion criteria for patients in the epilepsy subgroup: patients diagnosed with epilepsy secondary to autoimmune encephalitis.\n\nExclusion Criteria:\n\n* No additional exclusion criteria",{"count":459,"type":22},200,"This study aims to establish an autoimmune encephalitis cohort and observe the prognosis of patients with different subtypes and subgroups (e.g. epilepsy subgroup and teratoma subgroup ). Clinical characteristics, biological samples, and imaging data will be collected to discover blood and imaging biomarkers for providing support for the treatment, early warning, and outcome prediction.",[28],"2024-12-30",{"date":464,"type":42},"2025-01-06",{"date":466,"type":22},"2025-02-01",{"date":126,"type":22},{"name":400,"class":49},{"id":470,"slug":471,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":16,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":478,"conditions":479,"keywords":485,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":50},"100554663","biomarkers-in-autoimmune-disease-of-nervous-system-100554663","NCT06502015","Biomarkers in Autoimmune Disease of Nervous System","Biomarkers of Neurological Autoimmune Diseases","Inclusion Criteria:\n\n* Clinical diagnosis with autoinflammatory diseases of the nervous system, including: Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy(IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), ect al.\n* sex and age-matched healthy individuals\n\nExclusion Criteria:\n\n* Known history of primary immunodeficiency (innate or acquired).\n* Patients with severe central nervous system, pulmonary, or other systemic infections.\n* Patients with secondary central nervous system demyelinating lesions, such as those caused by vasculitis, systemic lupus erythematosus, and Sjögren's syndrome.\n* Patients with vascular (including hemorrhagic and ischemic), hereditary metabolic, neoplastic, or toxic diseases.\n* Pregnant or lactating women.",{"count":477,"type":22},50000,"Neurological autoimmune diseases are a group of disorders characterized by the abnormal immune response attacking the nervous system, including the brain, spinal cord and peripheral nerves. These diseases exhibit high heterogeneity, diverse clinical presentations, and are challenging to diagnose and manage due to a lack of effective treatments. In this study, the investigators will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy (IIM), and multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). Through this study, the investigators aim to discover biomarkers with high sensitivity, specificity, and stability, which can support early diagnosis, disease monitoring, and personalized treatment for neurological autoimmune diseases, thereby improving the quality of life and prognosis for patients.",[480,481,27,482,483,28,484,29,231,232,179],"Autoimmune Diseases of the Nervous System","Neuromyelitis Optica Spectrum Disorder","Guillain-Barre Syndrome","Acute Disseminated Encephalomyelitis","Stiff-Person Syndrome",[486,480,487],"Biomarker","Immune cell","2024-11-17",{"date":490,"type":42},"2024-11-20",{"date":492,"type":42},"2024-07-31",{"date":494,"type":22},"2027-07",{"name":242,"class":49},{"id":497,"slug":498,"hasResults":11,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":504,"enrollmentInfo":505,"targetDuration":4,"studyType":63,"phases":507,"briefSummary":508,"conditions":509,"keywords":511,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":50},"100405605","early-phase-1-safety-and-efficacy-of-ct103a-cells-for-relapsedrefractory-antibody-associated-inflammatory-diseases-of-the-nervous-system-100405605","NCT04561557","Safety and Efficacy of CT103A Cells for Relapsed\u002FRefractory Antibody-associated Inflammatory Diseases of the Nervous System","An Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed\u002FRefractory Antibody-associated Inflammatory Diseases of the Nervous System","CARTinNS","Inclusion Criteria:\n\n1. Male or female subjects aged 18-75 years (including 18 and 75 years);\n2. Subjects with Relapsing\u002Frefractory Antibody-mediated inflammatory diseases of the nervous system without effective treatment, including:\n\n   1. Subjects must be diagnosed as AQP4-IgG-positive NMOSD defined by 2015 criteria of IPND NMOSD and meet the following requirements: i. At least one kind of immunosuppressant has been used for more than one year with poorly-controlled symptoms; ii. Clinical evidence of at least two relapses in the last 12 months or three relapses in the last 24 months and one relapse in the preceding 12 months before screening.\n   2. Subjects with MG with positive abnormal antibody, MG-ADL total score ≥ 6 points, MGFA classification II-IV defined by 2020 MGFA diagnostic criteria and meet the following requirement: i. At least one kind of immunosuppressant for standardized treatment for more than 1 year, and have one of the following poor control conditions: 1) continuous inability to affect daily life; 2) Exacerbation of MG symptoms and\u002For crisis attacks still occur despite standard treatment; 3) Inability to tolerate immunosuppressive therapy ii. Requires plasma exchange or maintenance therapy with IV gamma globulin\n   3. Subjects with CIDP with positive abnormal antibodies, INCAT disability scale with total score of 2-9 defined by 2021 EAN\u002FPNS diagnostic criteria and meet the following requirement: i. Standardized use of at least one first-line therapy for more than 3 months (cortisol hormone therapy, gamma globulin or plasma exchange therapy) with poorly-controlled symptoms. ii. Inability to tolerate cortisol hormones, gamma globulin, and plasmapheresis because of side effects or other conditions\n   4. Subjects were diagnosed with IIM defined by 2017 European League against Rheumatism\u002FAmerican Rheumatology (EULAR\u002FACR) conference Class criteria; At least one kind of cardiac enzymes (CK, AST, ALT, ALD, LDH) ≥1.5×ULN during the screening period, or Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) ≥6, or at least one other sign of active disease within the last 6 months: MRI, EMG, or muscle biopsy; positive serological tests for myositis-specific antibodies (MSA) or myositis-associated autoantibodies (MAA), or antinuclear antibody (ANA). and meet one of the following requirements:\n\n   i. After at least 1 month of corticosteroid therapy and standardized use of at least one immunosuppressant\u002Fmodulator (eg, azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, Cyclophosphamide, leflunomide, intravenous gamma globulin, etc.) for more than 3 months with poorly-controlled symptoms.\n\n   ii. ii. Inability to tolerate the above traditional regimens due to side effects or other conditions;\n\n   e. Subjects were diagnosed with PMS (including PPMS and SPMS) or RMS according to the 2017 revision of the McDonald diagnostic criteria；EDSS score between 2 to 7 points inclusive, at screening. Subjects with RMS should meet one of the following requirements after standard therapy: i. at least two relapses in the last two years before screening. ii. at least one relapse in the last one year before screening. iii. positive Gd-enhancing MRI in the last one year before screening.\n\n   f. Subjects were diagnosed with POEMS syndrome according to the 2021 revised IMWG diagnostic criteria and meet all of the following requirements: i. bone marrow involvement; ii. no response to traditional regimens treatment including corticosteroid, chemotherapy, protease inhibitor or inability to tolerate the above traditional regimens; iii. Have measurable lesions (refer to the 2021 revised IMWG standard) iv. VEGF \\> 2 ULN; v. ECOG score ≥1; vi. ONLS score ≥1.\n\n   g. Subjects were diagnosed with autoimmune encephalitis according to the 2016 International Diagnostic Criteria for Autoimmune Encephalitis and meet all of the following requirements: i. at least one pathogenic antibody positive; ii. previously standardized use of corticosteroid, at least one immunosuppressant\u002Fmodulator, including CD20 monoclonal antibody with poorly-controlled symptoms or intolerance; iii. onset of autoimmune encephalitis within 3 months prior to screening; iv. mRS Score ≥2 or CASE score ≥4.\n\n   h. Subjects were diagnosed with MOGAD according to the 2023 International MOGAD Diagnostic criteria and meet all of the following requirements: i. a documented positive serum MOG Ab test using a cell-based assay (CBA); ii mRS Score ≥2; iii previously standardized use of corticosteroid, at least one immunosuppressant\u002Fmodulator, including CD20 monoclonal antibody with poorly-controlled symptoms or intolerance.\n3. All acute toxic reactions resolved to baseline or ≤ grade 1 assessed using NCI-CTCAE v5.0 except the ones adjudicated by the investigator to pose no risks on subjects.\n4. Enrolled subjects must have satisfactory organ function and laboratory findings as defined by the following:i. Blood tests: absolute neutrophil count ≥ 2×109\u002FL (or normal lower limit set by the central lab of the institution), platelets ≥ 100 × 109\u002FL, and hemoglobin ≥ 100 g\u002FL; ii. Liver function: total serum bilirubin, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤ 1.5x the institutional normal upper limit (ULN); iii. Kidney function: CrCl ≥ 60 ml\u002Fmin\u002F1.73m2 (according to the following Cockcroft-Gault formula); iv. Electrolytes: blood potassium ≥ 3.0 mmol\u002FL; blood calcium ≥ 2.0 mmol\u002FL, blood magnesium ≥ 0.5 mmol\u002FL; v. Coagulation function: fibrinogen ≥ 1.0 g\u002FL; APTT ≤ ULN + 10s; PT ≤ ULN + 3s.\n5. Blood oxygen saturation \\> 91% in resting state.\n6. Echocardiography suggests LVEF≥ 50%.\n7. Expected life expectancy ≥ 12 weeks as assessed by the investigator.\n8. After signing the informed consent form, subjects and their partners must be willing to use effective and reliable method of contraception, devices or medicines, within one year after CT103A cells infusion (excluding contraception safety periods).\n9. Subjects must provide written informed consent before the study begin.\n\nExclusion Criteria:\n\n1. Patients do not have adequate mononuclear cells without mobilization for CAR-T cell manufacturing.\n2. History of autoimmune hemolytic disease.\n3. History of solid organ transplantation.\n4. Patients were treated with alemtuzumab within 6 months prior to apheresis. Patients were treated with fludarabine or cladribine within 3 months prior to apheresis.\n5. Patients with Papovaviruses infection.\n6. Patients have been diagnosed with malignancies in the last 2 years prior to screening except for non-melanoma skin cancer, stage I cancers with complete resection and low risk of relapse, localized prostate cancer post-treatments, biopsy-confirmed in situ cervical cancer, or squamous epithelial lesion by PAP smear.\n7. Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.\n8. MG crisis was not effectively controlled within 2 weeks before enrollment.\n9. Known history of primary immunodeficiency (innate or acquired).\n10. Patients with severe impaired cardiac function, including but not limited to the following: unstable angina, myocardial infarction (within 6 months before enrollment), congestive heart failure (≥Grade III by NYHA), severe ventricular arrhythmia.\n11. Cerebrovascular accidents, including transient ischemic attack or stroke history, occurred within 6 months before enrollment.\n12. Major operation or surgical treatment caused by any reason within 4 weeks before enrollment.\n13. Any serious and\u002For uncontrolled comorbidities which may interfere with the evaluation during the study in the opinion of the investigator\n14. Previous treatments: History of thymectomy within 12 months prior to CT103A infusion;\n15. History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.\n16. Prone to allergies or history of serious allergy.\n17. Pregnant or lactating women.\n18. Patients with other conditions adjudicated by the investigator as unsuitable for enrollment.\n\nCriteria for lymphodepletion and CAR-T cells infusion:\n\nBefore lymphocyte depletion and CAR-T cells infusion, patients are evaluated and those meeting the following criteria cannot be included:\n\n1. Blood tests: neutrophil count \\\u003C 2 × 109\u002FL, platelet count \\\u003C 50 × 10\\^9\u002FL;\n2. Oxygen inhalation is required to maintain blood oxygen saturation ≥ 91%;\n3. Patients have the following conditions, including but not limited to: new arrhythmia cannot be controlled by drugs; hypotension requiring pressor drugs; bacterial, fungal or viral infection requiring intravenous antibiotic treatment; creatinine clearance rate \\\u003C 50 ml\u002Fmin ;\n4. Patients require maintenance support treatment within one week to meet the criteria for lymphodepletion or CAR T cell infusion.\n5. Cell infusion is delayed \\> 7 days after lymphodepletion for any reason;\n6. Patients with other conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.","75 Years",{"count":506,"type":22},36,[280],"Antibody-mediated inflammatory diseases of the nervous system (also known as autoimmune diseases of the nervous system) are autoimmune diseases in which autoimmune cells and immune molecules attack the nervous system as the main pathogenic mechanism. In the immune response, pathogenic antibodies acting on autoantigens of the nervous system are collectively referred to as autoantibodies of the nervous system, and antibody-mediated inflammatory diseases of the nervous system can occur in the central nervous system, peripheral nervous system, and neuromuscular junctions, and muscles. In this study, we will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathyand (IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) and POEMS Syndrome. B-cell maturation antigen (BCMA) is expressed on the surface of plasma cells, thus making it an ideal target for targeted therapies. Chimeric antigen receptor (CAR) T cells against BCMA offers another potential therapeutic option to eliminate plasma cells in patients with neurological autoimmune diseases driven by abnormal antibody who still suffer recurrent attacks from conventional treatments. In the current study, the safety and efficacy of a novel CAR-T cell therapy using CT103A cells, are evaluated in patients with relapsed\u002Frefractory antibody-mediated idiopathic inflammatory diseases.",[179,480,481,29,231,232,27,28,31,510],"POEMS Syndrome",[512,513,514,480],"Adoptive T Cell Therapy","Chimeric antigen receptor","B-cell maturation antigen (BCMA)","2024-10-27",{"date":517,"type":42},"2024-10-30",{"date":519,"type":42},"2020-09-22",{"date":521,"type":22},"2027-05-31",{"name":242,"class":49},{"id":524,"slug":525,"hasResults":11,"nctId":526,"briefTitle":527,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":11,"sex":58,"minAge":529,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":4},"100551180","clinical-features-and-prognostic-markers-in-adult-patients-with-ae-requiring-icu-treatment-100551180","NCT06456736","Clinical Features and Prognostic Markers in Adult Patients With AE Requiring ICU Treatment","Inclusion Criteria:\n\n* Diagnosed as either ''definite'' or ''probable'' AE based on Chinese guidelines for diagnosis and treatment of AE (version 2022)\n* Age ≥ 15 years\n* Admission to an adult ICU during the course of the disease\n\nExclusion Criteria:\n\n* Missing data on primary outcome\n* ICU length of stay of 24 hours or less.","15 Years",{"count":459,"type":22},"Autoimmune encephalitis (AE) is a potentially life-threatening inflammation of the central nervous system (CNS) and constitutes 20%-30% of encephalitis cases in adults AE often leads to subacute, severe, and debilitating encephalitis necessitating long-term management in a neurologic intensive care unit (ICU). This study aims to explore the predictive factors for poor clinical outcomes by analyzing the clinical characteristics and prognosis of adult patients with critical AE requiring ICU admission. Prospective observational single center study in neurologic ICU, the second Xiangya hospital, Central South University. All patients admitted to the ICU for probable or confirmed AE (2022 Chinese guidelines for diagnosis and treatment of AE) will be included. Factors associated with a poor prognosis will be identified by multivariate analysis using a logistic regression.",[28],"2024-06-12",{"date":535,"type":42},"2024-06-13",{"date":537,"type":22},"2024-06",{"date":539,"type":22},"2024-08",{"name":541,"class":49},"Central South University",{"id":543,"slug":544,"hasResults":11,"nctId":545,"briefTitle":546,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":551,"conditions":552,"keywords":554,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":50},"100498619","characterization-of-immune-response-in-autoimmune-encephalitis-and-paraneoplastic-neurological-syndromes-100498619","NCT05772611","Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes","Car-Te-Cell","Inclusion Criteria:\n\n* Patient with neurological disorder\n* Patient with antibodies or not in sera or CSF\n\nExclusion Criteria:\n\n\\- No available clinical data",{"count":550,"type":22},180,"Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare neuroimmune syndromes with a wide range of clinical presentation but without pathognomonic clinical sign facilitating the diagnosis. A lot of differential diagnoses are possible such as neurodegenerative diseases or viral infections. Although rare the diagnosis of AE or PNS is essential because despite severe neurological symptoms, patients can be cured by appropriate immunotherapy. Autoantibodies highly specific of AE and PNS has been described in the serum and cerebrospinal fluid of the patients and can be used as biomarkers of the disease. Their presence can predict an autoimmune origin and in many cases a good prognosis after immunotherapy. However, if some autoantibodies are now well-characterized and industrial kits have been developed to detect them, in numerous cases of highly suspect AE or PNS no specific autoantibodies are identified leading frequently to an inappropriate treatment. Furthermore, as the mechanisms of AE and PNS is still unknown, treatments are not optimal and in some cases inefficient. There is no prognosis biomarker able to predict the patient's sensitivity to immunotherapy and there are only few clues to know how the immune system can provoke the neuropsychiatric symptoms observed in the patients.",[28,553],"Paraneoplastic Neurological Syndrome",[310,555,556],"paraneoplastic neurological syndromes","genetic","2023-03-06",{"date":559,"type":42},"2023-03-16",{"date":561,"type":42},"2022-02-01",{"date":563,"type":22},"2029-02-15",{"name":565,"class":49},"Hospices Civils de Lyon"]