[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"early-alzheimers-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:early-alzheimers-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,70,94,118,146],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100595518","phase-2-a-clinical-study-of-mk-2214-in-people-with-early-alzheimers-disease-mk-2214-004-100595518",false,"NCT07033494","A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)","A Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MK-2214 in Participants With Early Alzheimer's Disease","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD)\n* Has a designated study partner who can fulfill the requirements of this study\n* If on an approved AD therapy for symptomatic AD, the dosing regimen must have been stable for 3 months prior to screening\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a known history of stroke or cerebrovascular disease\n* Has diagnosis of a clinically relevant central nervous system disease other than AD or other condition that negatively impacts cognition or cognitive status chronically\n* Has structural brain disease\n* Has a history of seizures or epilepsy within 5 years before screening\n* Has any other major central nervous system trauma, or infections that affect brain function\n* Has major medical illness or unstable medical condition within 3 months before screening\n* Has a severe, acute, or chronic medical or psychiatric condition or laboratory abnormality\n* Has any immunological disease, which is not adequately controlled, or which requires treatment with biologics and\u002For immunosuppressants during the study\n* Has a bleeding disorder that is not under adequate control\n* Has a history of malignancy occurring within 5 years of screening\n* Has a risk factor for corrected QT interval (QTc) prolongation\n* Has liver disease\n* Is unwilling or unable to undergo computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) scan\n* Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision","ALL","50 Years","85 Years",{"count":20,"type":21},340,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Researchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. MK-2214 is a study treatment designed to slow down AD.\n\nThe goals of the study are to learn:\n\n* If MK-2214 slows the spread of tau in the brain compared to placebo. Tau is a protein that accumulates in AD \\& damages brain cells. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment.\n* About the safety of MK-2214 and if people tolerate it",[27],"Early Alzheimer's Disease","RECRUITING","2026-06-19",{"date":31,"type":32},"2026-06-23","ACTUAL",{"date":34,"type":32},"2025-07-16",{"date":36,"type":21},"2029-04-30",{"name":38,"class":39},"Merck Sharp & Dohme LLC","INDUSTRY",78,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100632336","phase-2-human-mesenchymal-stem-cells--monoclonal-antibodies-in-the-treatment-for-mild-cognitive-impairment-or-early-alzheimers-disease-100632336","NCT07512362","Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.","A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to Patients Treated With Anti-Amyloid Monoclonal Antibodies Who Are Suffering From Mild Cognitive Impairment or Mild Alzheimer's Disease.","Inclusion Criteria:\n\n* Adults 55-90 years at the time of signing consent\n* Patients diagnosed with Mild Cognitive Impairment or mild Dementia due to Alzheimer disease, receiving treatment with an FDA approved monoclonal antibody (Leqembi\u002FLecanemab or Kisunla\u002FDonanemab) for at least 6 months prior to the infusion visit.\n* MMSE score 20-26.\n* Patients must be able to consent.\n* Have a family member or friend (study partner) who has frequent and sufficient contact with the patient and is able to answer questions about the participant's daily activities to complete the ADCS-MCI-ADL. Completing this scale is required to assess the impact of the study intervention on cognitive function and daily living skills in this patient population. Having a study partner is a requirement of this study.\n\nExclusion Criteria:\n\n* Dementia other than AD\n* Patient with severe depression. Patients with controlled depression are allowed to participate.\n* Inability to independently provide informed consent is considered exclusionary per protocol requirements\n* Recent history of substance abuse\n* History of bleeding disorders, HIV, HCV or HBV\n* Recent history (within 3 years) of malignancies, except for treated basal cell, squamous carcinoma or melanoma in situ, prostate in situ, cervical carcinoma in situ.\n* Uncontrolled medical conditions (hypertension, diabetes, unstable angina or MI within 1 year prior to screening)\n* History of bleeding disorder\n* Currently receiving (or received within four weeks of screening) experimental agents for the treatment of Alzheimer's Disease or enrolled in clinical trials in the prior 3 months.\n* Be a transplant recipient or in any other active medical condition than in the opinion of the investigator may compromise the safety or compliance of the patient or preclude successful completion of the study\n* Be premenopausal","55 Years","90 Years",{"count":51,"type":21},10,[24],"The purpose of this study is to test if adding one infusion of (Human Mesenchymal Stem Cells) hMSCs to the treatment with standard of care (SOC) monoclonal antibodies (mAb) will stabilize the rate of cognitive and functional decline associated with mild Alzheimer's Disease.",[55,27,56],"Mild Cognitive Impairment","AD-MCI",[55,58,56,27],"MCI","2026-05-26",{"date":61,"type":32},"2026-05-28",{"date":63,"type":32},"2026-05-15",{"date":65,"type":21},"2028-06-15",{"name":67,"class":68},"Bernard (Barry) Baumel","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":18,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100631080","safety-and-efficacy-of-l-lactis-ckdb001-in-subjects-with-early-alzheimers-disease-100631080","NCT07496021","Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease","A Randomized, Placebo-Controlled, Double-Blind, 24-Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease","Inclusion Criteria:\n\n1. Male and female adults aged ≥55 and ≤85 years at the time of written consent\n2. Subjects with a Korean Mini-Mental State Examination (K-MMSE) score of 20 to 28\n3. Have a global Clinical Dementia Rating (CDR) score of 0.5 to 1 and a CDR Memory Box score of 0.5 or greater\n4. Subjects who test positive for amyloid on Positron Emission Tomography (PET)\n\nExclusion Criteria:\n\n1. Subjects with clinically significant diseases other than Alzheimer's disease that may confound cognitive assessment\n\n   * History of central nervous system (CNS) diseases\n   * Active central nervous system (CNS) infection capable of affecting cognitive function, or a history of infection resulting in neurological sequelae\n   * Structural brain abnormalities identified on screening MRI that could account for cognitive impairment\n   * Abnormal thyroid function identified at screening\n   * Vitamin B12 deficiency identified at screening\n2. History of seizure disorder or epilepsy\n3. History or suspicion of alcohol or substance abuse\u002Fdependence\n4. History of psychiatric disorders, including schizophrenia, bipolar disorder, or clinically significant major depressive disorder, with current active symptoms\n5. History of malignancy diagnosed or recurrent within 5 years prior to screening\n6. History of a major cardiovascular event within 12 months prior to screening\n7. Cardiovascular disease requiring the administration of anticoagulants\n8. Severe or active infectious disease requiring treatment with antibiotics or antivirals within 4 weeks prior to randomization, or expected to require such treatment during the study period\n9. Clinically significant gastrointestinal disorders within 3 months prior to screening, or conditions that may lead to malabsorption\n10. Treatment with any disease-modifying therapy for Alzheimer's disease within 1 year prior to screening\n11. Initiation or dosage\u002Fregimen changes of symptomatic treatments for dementia within 12 weeks prior to screening\n12. Chronic use of medications acting on the CNS or those that may affect cognitive function within 8 weeks prior to screening\n13. Regular use of medications that may alter the gut microbiota within 4 weeks prior to screening",{"count":78,"type":21},60,[80],"NA","Randomized, Placebo-Controlled, Double-Blind, 24-Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease",[83],"Early Alzheimers Disease","2026-03-25",{"date":86,"type":32},"2026-03-30",{"date":88,"type":32},"2026-02-23",{"date":90,"type":21},"2027-05-31",{"name":92,"class":39},"CKD Bio Corporation",2,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":18,"enrollmentInfo":101,"targetDuration":4,"studyType":103,"phases":4,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":69},"100630244","a-study-to-compare-two-different-sleep-tests-in-participants-with-no-symptoms-or-early-symptoms-of-alzheimers-disease-100630244","NCT07485153","A Study to Compare Two Different Sleep Tests in Participants With No Symptoms or Early Symptoms of Alzheimer's Disease","A Study to Assess the Use of the Somfit, an Ambulatory Electroencephalogram-Based Digital Health Technology, Compared With Polysomnography to Evaluate Sleep Architecture in Individuals With Asymptomatic or Early Alzheimer's Disease","Inclusion Criteria:\n\n* Have mild cognitive impairment, subjective memory complaints, or normal cognition.\n* Evidence of the presence of Alzheimer's pathology as measured by amyloid positron emission tomography (PET), cerebrospinal fluid biomarkers (amyloid beta and tau), or blood biomarkers.\n* Montreal Cognitive Assessment (MoCA) score of 24 or greater.\n* Clinical Dementia Rating Scale (CDR) global score of 0 or 0.5.\n* Able to provide signed informed consent.\n* On stable medications (including those for Alzheimer's disease) for 30 days before the first recording night of Study Period 1, and willing to remain on stable therapy during the study.\n* Must have a study partner who knows the participant well and can accompany the participant at visits where informant-rated scales are administered.\n\nExclusion Criteria:\n\n* Severe illness that in the investigator's judgement would adversely affect the participant's participation in the study.\n* Skin illness that may interfere with study assessments.\n* Has a pacemaker or implantable cardioverter defibrillator.\n* Diagnosed with a sleep disorder.\n* Has irregular circadian patterns (works night shifts, etc.).\n* Is pregnant or lactating\u002Fbreastfeeding at time of screening.\n* Use of sleep aid medications (such as melatonin, Ambien, Lunestra) or other medications or substances that could affect sleep (alcohol, cannabinoids, or opioids) on nights of in-clinic and at-home recordings.\n* Currently enrolled in another clinical study involving an investigational product or other type of medical research judged not to be scientifically or medically compatible with this study.\n* People who habitually spend less than 5 hours in bed per night.\n* No alcohol will be allowed at least 24 hours before the use of the EEG and throughout the clinical assessment period.",{"count":102,"type":21},35,"OBSERVATIONAL","The purpose of this study is to compare the results of two different sleep tests in Alzheimer's patients with no symptoms or early symptoms. Participants will undergo two simultaneous sleep tests (polysomnography) in a sleep laboratory for two nights and one sleep test at home for three nights. For each participant, the study will last at least a week and will last up to three months.",[106,27,107],"Alzheimer's Disease","Memory Problems","NOT_YET_RECRUITING","2026-03-17",{"date":111,"type":32},"2026-03-20",{"date":113,"type":21},"2026-03",{"date":115,"type":21},"2026-09",{"name":117,"class":39},"Eli Lilly and Company",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":125,"maxAge":18,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":69},"100612350","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-ttyp01-tablets-in-early-symptomatic-alzheimers-disease-100612350","NCT07252440","A Study to Evaluate the Efficacy and Safety of TTYP01 Tablets in Early Symptomatic Alzheimer's Disease","A Prospective, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of TTYP01 Tablets in Early Symptomatic Alzheimer's Disease","Inclusion Criteria\n\nParticipants must meet all the following criteria to be eligible for this study:\n\n1. Age between 60 and 85 years (inclusive, based on the date of signing the informed consent), applicable to all genders.\n2. Must meet the 2024 Alzheimer's Association (AA) Workgroup revised criteria for diagnosing MCI due to AD or mild AD dementia.\n3. CDR score: At screening and baseline, the CDR global score must be 0.5 or 1.0, and the CDR memory score must be 0.5 or higher.\n4. MMSE score: At screening, the MMSE score must be 22 or higher.\n5. Body mass index (BMI): At screening, BMI must be greater than 17 and less than 35 (inclusive).\n6. History of memory decline: A history of at least 6 months of gradual and progressive memory decline prior to signing ICF must be reported and confirmed by an informant.\n7. Blood p-tau 217: positive (For participants with evidence suggesting Aβ-PET positivity, absence blood p-tau 217 determination is not considered a protocol deviation.).\n8. Aβ- PET scan: Visual read of Aβ-PET scan must be positive.\n9. Study partner: Must have a designated study partner who can support the participants and spend at least 8 h per week with them during the study. The partner must provide a separate written informed consent and be willing and able to provide follow-up information about the participant. They should regularly spend enough time with the participants to reliably meet study requirements. The study partner does not need to live with the participant but should be easily reachable during the study. If the partner is unable to continue supporting due to health or other reasons, it is allowed to replace with another eligible partner. The replacement partner must provide a separate written informed consent and be willing and able to provide follow-up information about the participant.\n10. Concomitant medication: Participants who are receiving cholinesterase inhibitors and\u002For memantine for AD can be enrolled into the study, but must be on a stable dose for at least 12 weeks prior to baseline. For all other (i.e., non-AD-related) allowed concomitant medications, participants must receive a stable dose (not for topical, as needed \\[PRN\\], or discontinued medications) for at least 4 weeks prior to baseline unless otherwise stated.\n11. Contraception:\n\n    a.Male participants i.Male participants, regardless of childbearing potential, if their non-pregnant female partner is a female of childbearing potential, must agree to maintain abstinence (if this is their preferred and usual lifestyle) or to use a barrier method and another highly effective (failure rate less than 1%) method of contraception (see Section 17.5 for details) until 90 days after the last dose of IP.\n\n    ii.Male participants with pregnant partners should use condoms during intercourse for the duration of the study and until the end of the estimated relevant potential exposure for women of childbearing potential (WOCBP; expected to be 90 days after the last dose of IP).\n\n    iii.Male participants should refrain from sperm donation for the duration of the study and until 90 days following the last dose of IP.\n\n    b.Female participants i.WOCBP must use, or be willing to use, two forms of effective contraception (a barrier method and one other highly effective method of contraception, as detailed in Section 17.5) during participation in the trial and for 90 days after the last dose of the IP.\n\n    ii.WOCBP potential is defined as those who are:\n\n    ① Following menarche\n\n    ② From the time of menarche until becoming postmenopausal unless permanently sterile (see below) A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n    * In the absence of 12 months of amenorrhea, confirmation with more than one follicle-stimulating hormone (FSH) measurement is required.\n    * Individuals receiving hormone replacement therapy (HRT) whose menopausal status is in doubt will be required to use a non-estrogenic, highly effective contraceptive method if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.\n\n    Permanent sterilization methods and gender-affirming procedures (for the purpose of this study) include:\n    * Documented hysterectomy\n    * Documented bilateral salpingectomy\n    * Documented bilateral oophorectomy\n    * For individuals with permanent infertility due to an alternate medical cause other than the above, (e.g., Mullerian agenesis, androgen insensitivity, gonadal dysgenesis), investigator discretion should be applied to determining study entry.\n\n    iii.All WOCBP must be negative at Visit 1 based on a serum pregnancy test.\n12. Informed consent: Must obtain a voluntary signed ICF, approved by an Ethics Committee, from the participants or their legal representative before any study procedure.\n13. Language proficiency: Must be fluent in the language used at the study site.\n14. Protocol compliance: Must be willing and able to comply with all aspects of the protocol.\n\nExclusion Criteria\n\nParticipants who meet any of the following exclusion criteria will not be eligible for the study:\n\n1. History of intracranial infection or traumatic brain injury.\n2. Severe coronary heart disease, cardiac insufficiency (New York Heart Association Class Ⅲ and Class IV), atrial fibrillation, and other heart diseases within six months prior to signing ICF.\n3. Malignancy:\n\n   * History of cancer within the last 3 years, with the exception of non-metastatic basal and\u002For squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with a low risk of recurrence or spread.\n   * Intracranial space occupying lesions or brain tumors will be excluded unless, based on the opinion of the investigators and medical monitors, the medical condition will not interfere with cognitive assessments and safety.\n4. Severe hematologic disorders, such as myelodysplastic syndrome, aplastic anemia, lymphoma, leukemia, etc.\n5. Peptic ulcer or obstruction or other diseases that affect the absorption of oral medication.\n6. Any neurological disorder that may cause cognitive impairment beyond the impact of AD.\n7. Any psychiatric diagnosis or neuropsychiatric symptom (such as hallucinations, major depression, or delusions) that may interfere with the participant's study procedure.\n8. A history of transient ischemic attack (TIA), stroke, or seizure in the 12 months prior to signing ICF.\n9. The Hachinski Ischemic Index Scale (HIS) at screening \\> 4 points.\n10. ECG at screening or at baseline showing prolonged QTcF \\[Fridericia correction formula, see Section 17.4\\] (QTcF \\> 480 ms in women; QTcF \\> 470 ms in men) or other clinically significant abnormalities of the ECG that are considered by the investigator to be unsuitable for participation in a clinical study (e.g., heart rate \\\u003C 50 beats\u002Fmin, sinus node lesions, Morse II or third-degree atrioventricular block, etc.).\n11. The Geriatric Depression Scale (GDS) score at screening ≥ 8 points.\n12. Contraindications to MRI scans, including pacemakers\u002Fdefibrillators, ferromagnetic metal implants (in addition to those approved for safe use in MRI scanners, such as cranial and cardiac devices).\n13. Contraindications with PET scanning, allergies to tracers.\n14. Brain MRI at screening reveals evidence of other clinically significant lesions, suggesting a possible diagnosis of dementia other than AD.\n15. Brain MRI at screening reveals the presence of a single hemorrhage with a maximum diameter \\> 10 mm and investigator assesses the participant is unsuitable for this study; Evidence of angioedema.\n16. Participants with inadequately controlled bleeding disorder (including platelet count \\\u003C 100,000\u002FµL or international normalized ratio \\[INR\\] \\> 1.5).\n17. Thyroid stimulating hormone levels above or below the normal range. Participants with results of other thyroid function tests that fall outside the normal range will be excluded only if they are considered clinically significant by the investigator.\n18. Laboratory test results for serum vitamin B12 levels below the normal range, as well as participants who are receiving vitamin B12 supplement therapy.\n19. Positive serological finding for human immunodeficiency virus (HIV), active syphilis, Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody.\n20. Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG present at screening or baseline that the investigator determines the situations that affected the safety of the participants or other interferences with the study.\n21. Have a known or suspected history of drug or alcohol abuse.\n22. Serious or unstable disease, or any other medical condition (e.g., heart, respiratory, gastrointestinal, liver, kidney, endocrine and nervous system disease, including poorly controlled hypertension, with a systolic blood pressure of ≥160mmHg or a diastolic blood pressure of ≥100 mmHg; Poorly controlled diabetes, etc.) that the investigator believes may affect the participant's safety or interfere with study evaluation.\n23. Previous use of prohibited drugs, including disease-modifying drugs (Such as approved lecanemab, donemab, etc. or other disease-modifying investigational medicinal products), anti-oxidative stress drugs (other formulations of edaravone).\n24. Have scheduled surgical procedures requiring general anesthesia during the study period. For a scheduled procedure that requires only local anesthesia and performed as a day procedure without the need for post-operative hospitalization, participant does not need to be excluded if the investigator determines that the procedure does not interfere with study procedures or participant safety.\n25. Severe vision, hearing, reading, comprehension, or physical dysfunction that prevents the participant from accurately performing neuropsychological tests.\n26. Have been diagnosed with serious active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc., or alanine transaminase (ALT) \\> 2 × upper limit of normal (ULN) or aspartate aminotransferase (AST) \\> 2 × ULN, or total bilirubin (TBIL) \\> 1.5 × ULN.\n27. Have been diagnosed with severe active kidney disease, renal insufficiency; or serum creatinine \\> 1.5 × ULN or creatinine clearance \\\u003C 50 mL\u002Fmin at screening and baseline (Calculated based on the Cockcroft-Gault formula, see Section 17.6 for details).\n28. Have severe systemic disease and life expectancy is \\\u003C 2 years.\n29. Answer \"yes\" to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before screening, at screening, or at the baseline visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before screening.\n30. Allergic to edaravone, sodium bisulfite, or soluplus excipients (Note: Asthma patients are sensitive to sulfites and may have allergic reactions. For patients with a history of asthma, the investigator will carefully assess whether to enroll them.).\n31. History of major surgery within 4 weeks prior to enrollment.\n32. Have participated in, or are currently participating in, another clinical study within the 30 days prior to randomization (Participants who have previously participated in clinical studies of disease-modifying drugs targeting Aβ and\u002For tau pathology will follow exclusion criteria 23).\n33. Participants who have received cholinesterase inhibitors, memantine within 12 weeks prior to randomization and stopped treatment due to safety concerns or other reasons and refuse to or unable to receive it again.\n34. Female participants who are pregnant, breastfeeding, planning to become pregnant recently, or unwilling to use contraceptive measures.\n35. Have other conditions that investigator believes the participant is unsuitable for this study.","60 Years",{"count":127,"type":21},180,[24],"This is a multicenter, randomized, double-blind, placebo-controlled parallel Phase II core period study to evaluate the efficacy and safety of TTYP01 Tablets in early symptomatic AD (Mild cognitive impairment \\[MCI\\] due to AD, or mild AD dementia).\n\nA total of 180 participants will be randomized into 3 parallel groups: 2 TTYP01 dose groups and 1 placebo group.",[131,27],"AD",[131,106,133,134,135,136],"TTYP01","Placebo-Controlled","Double-Blind","Early Alzheimer's disease","2025-11-19",{"date":139,"type":32},"2025-11-26",{"date":141,"type":21},"2025-12-05",{"date":143,"type":21},"2028-11-23",{"name":145,"class":39},"Shanghai Auzone Biological Technology Co., Ltd.",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":159,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":69},"100559516","effect-of-transcranial-alternating-current-stimulationtacs-for-early-alzheimers-disease-100559516","NCT06565143","Effect of Transcranial Alternating Current Stimulation(tACS) for Early Alzheimer's Disease","Inclusion Criteria:\n\n1. Subject diagnosed with early Alzheimer's disease or related diseases according to NIA-AA criteria.\n2. Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia.\n3. CDR score ≤ 2.\n4. Subject under treatment by IAChE for at least 3 months.\n5. psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months.\n\nExclusion Criteria:\n\n1. CDR \\> 2\n2. Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).\n3. History of head injury,stroke,or other neurologic disease.\n4. Organic brain defects on T1 or T2 images.\n5. History of seizures or unexplained loss of consciousness.\n6. Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.\n7. Family history of medication refractory epilepsy.\n8. History of substance abuse within the last 6 months.",{"count":153,"type":21},40,[80],"To investigate the clinical effect neural mechanism of transcranial alternating current stimulation in early Alzheimer's disease",[157,158,27],"Transcranial Alternating Current Stimulation","Electroencephalography",[157,158,160,27,161,162],"Neuropsychology","Alzheimer's Disease Assessment Scale-Cognitive Subscale","Working Memory","2024-08-19",{"date":165,"type":32},"2024-08-21",{"date":167,"type":32},"2024-03-01",{"date":169,"type":21},"2026-07-01",{"name":171,"class":68},"Anhui Medical University"]