[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"St. Joseph's Hospital and Medical Center, Phoenix\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":259},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,43,62,100,124,146,177,207,233],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100560518","assess-all-als-study-100560518",false,"NCT06578195","ASSESS ALL ALS Study","ASSESS ALL ALS - Longitudinal Biomarker Study for Symptomatic ALS and Control Participants","Inclusion Criteria for ALS participants:\n\n1. Age 18 years or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. Diagnosis of ALS by a physician\n5. Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)\n\nInclusion Criteria for control participants:\n\n1. Age 18 years or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. No diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS)\n5. No history of familial ALS\u002FFrontotemporal Dementia (FTD) in a close family member\\*\\* unless the participant has previously tested negative for the known causative ALS genes. Participants with a family history of singleton ALS are permitted to enroll.\n\n   * \\*\\* Defined by the presence of a known ALS causative gene such as C9orf72 in a family member or a family history suggestive of an inherited ALS\u002FFTD syndrome defined by two family members with a history of ALS and\u002For FTD.\n6. Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)\n\nExclusion Criteria for all participants:\n\n1. Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression \\\u003C= 90 days of screening, that would interfere with the study procedure, according to Investigator's judgement.\n2. Clinically significant unstable medical condition (other than ALS) (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment.\n\nExclusion Criteria for participants undergoing optional Lumbar Puncture\n\n1. Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure).\n2. Allergy to Lidocaine or other local anesthetic agents.\n3. Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.\n4. Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.\n5. Current pregnancy based on participant self-report\n6. Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.",true,"ALL","18 Years",{"count":20,"type":21},2000,"ESTIMATED","OBSERVATIONAL","The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is being funded by the National Institutes of Health\u002FNational Institute of Neurological Disorders and Stroke (NIH\u002FNINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases.\n\nASSESS protocol is specific for symptomatic ALS and control participants. This protocol includes both on-site and off-site(remote) participants. The participants will be followed for 24 months (2 years), and will include collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once a month. Participants who are coming into clinic may also provide optional Cerebrospinal Fluid (CSF) samples.",[25],"Amyotrophic Lateral Sclerosis",[27,25,28,29],"ALS","biomarker","observational","RECRUITING","2026-06-15",{"date":33,"type":34},"2026-06-17","ACTUAL",{"date":36,"type":34},"2024-07-25",{"date":38,"type":21},"2029-07-25",{"name":40,"class":41},"St. Joseph's Hospital and Medical Center, Phoenix","OTHER",32,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":60,"leadSponsor":61,"locationsCount":42},"100560800","prevent-all-als-study-100560800","NCT06581861","PREVENT ALL ALS Study","PREVENT ALL ALS - Longitudinal Biomarker Study for Participants Who Are Genetically at Risk for Amyotrophic Lateral Sclerosis (ALS)","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. First-degree relative of a known carrier of any ALS causative gene1 (regardless of whether ALS or FTD has actually been symptomatic in the family) OR First-degree relative of an individual with ALS and\u002For FTD in a family with a \"compelling family history\" of ALS\u002FFTD, regardless of whether genetic testing has occurred in symptomatic family members. A \"compelling family history\" is defined as a pedigree with at least 2 close relatives who had ALS or FTD, with at least one of those family members having had ALS.\n5. Access to a smartphone, computer, or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)\n\nExclusion Criteria:\n\n1. Evidence of neurological signs or symptoms concerning for ALS of FTD, at the discretion of the site investigator which will be communicated to the applicant along with referral for appropriate clinical follow-up.\n2. Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression \\\u003C= 90 days (about 3 months) of screening, which in the opinion of the Investigator would interfere with the study procedures\n3. Clinically significant, unstable medical condition (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment\n\nExclusion Criteria for Participants Undergoing Optional Lumbar Puncture\n\n1. Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure).\n2. Allergy to Lidocaine or other local anesthetic agents.\n3. Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.\n4. Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.\n5. Current pregnancy based on participant self-report\n6. Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.\n\nInclusion Criteria for Genetic Testing Results Sub-study\n\n1. Age 18 years of age or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. Currently enrolled in the PREVENT ALS Study",{"count":51,"type":21},600,"The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is begin funded by the National Institutes of Health\u002FNational Institute of Neurological Disorders and Stroke (NIH\u002FNINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases.\n\nPREVENT protocol is specific for asymptomatic participants who are genetically at risk for ALS. The participants will be followed for up to 36 months (3 years), and will include 4 in-person on-site visits once a year and 6 off-site(remote) visits once in 4 months. The study includes collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once in 4 months. Participants may also provide optional Cerebrospinal Fluid (CSF) samples.The participants may also opt into a sub-study if they are interested in genetic testing for ALS causative genes. The sub-study will involve a minimum of 3 visits over a course of 2-3 months. This will include a screening\u002Fpre-test genetic counseling visit, a return of genetic results and a post-test counseling visit.",[25],[27,25,55,56,57],"Biomarker","Observational","at-risk",{"date":33,"type":34},{"date":36,"type":34},{"date":38,"type":21},{"name":40,"class":41},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":17,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100565215","phase-2-repurposing-siponimod-for-alzheimers-disease-100565215","NCT06639282","Repurposing Siponimod for Alzheimer's Disease","SIPO1-AD: A Phase II Clinical Trial for the Assessment of Safety, Tolerability, and Efficacy of Siponimod in Patients With Mild Alzheimer's Disease","SIPO1-AD","Inclusion Criteria:\n\n1. Male or female at least 50 years of age, but less than 85 (84 at time of screening)\n2. Females must be of non-childbearing potential or have negative pregnancy test at time of screening. Women of non-childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy or bilateral salpingectomy) or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for \\>12 months prior to the planned date of enrollment.\n3. Must have a diagnosis of mild Alzheimer's Dementia determined by medical record review.\n4. Vision and hearing must be sufficient to comply with study procedures.\n5. Be able to take oral medications.\n6. Must be able to attend all study visits indicated in the schedule of visits.\n7. Must have a collateral informant\u002Fstudy partner who has significant direct contact with the patient at least 10 hours per week and who is willing to accompany the patient to specified clinic visits, supervise administration of all study medication, and be available for telephone visits\u002Finterviews.\n8. Documented Mini Mental State Exam (MMSE) score between 20-26 at Screening Visit Day 1.\n9. CT or MRI scan of the brain within 12 months of Screening Visit Day 1 showing no evidence of significant focal lesions or other pathology which could contribute to dementia. If neither a CT or a MRI scan is available from the past 12 months, a scan fulfilling the requirements must be obtained before randomization.\n10. Hachinski ischemic score must be \\\u003C 4.\n11. Geriatric depression scale must be \\\u003C 10.\n12. Prior to dosing all randomized study subjects must show proof they have received immunization to varicella (VZV IgG).\n13. Each patient must be assessed for capacity to consent by the principal or sub-investigators in order to provide informed consent. If the patient is deemed unable to provide informed consent, they must have a legally authorized representative (LAR), and the LAR must review and sign the informed consent form. If the patient does not have a LAR, the patient must appear able to provide informed consent and must review and sign the informed consent form. If the patient is deemed unable to provide informed consent and does not have a LAR, they cannot participate in the study. In addition, the patient's study partner\u002Finformant (as defined in the study inclusion criteria) must sign the informed consent form. If the LAR and the patient's study partner\u002Finformant are the same individual, he\u002Fshe should sign under both.\n14. No active suicidality identified on Columbia-Suicide Severity Rating Scale (C-SSRS).\n15. Patients with stable prostate cancer may be included at the discretion of the Medical Monitor.\n16. Patients who are on monoclonal antibody medication for the treatment of Alzheimer's (ex. lecanemab, donanemab) for \\> 6 months or have discontinued monoclonal antibody medication for the treatment of Alzheimer's for \\> 6 months may be included if all other criteria has been met.\n\nExclusion Criteria:\n\n1. Taking one of the following medications: Medications for treatment of cancer or other drugs that weaken the immune system (ex. Natalizumab and Rituximab), Amiodarone, Bishydroxycoumarin, Chloramphenicol, Cimetidine, Fluconazole, Fluvastatin, Miconazole, Phenylbutazone, Sulphinpyrazone, Sulphadiazine, Sulphamethizole, Sulfamethoxazole, Sulphaphenazole, Trimethoprim, and Zafirlukast.\n2. Current active infection in participants including, but not limited to, herpes zoster, herpes infection, bronchitis, sinusitis, upper respiratory infection and fungal skin infection. Siponimod may increase the risk in participants with active infections.\n3. If participant received mRNA COVID-19 vaccination, must have received last dose at least 3 months prior to first dose of study drug\u002Fplacebo.\n4. Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including (but not limited to) epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness.\n5. Meets DSM IV criteria for any major psychiatric disorder including psychosis, major depression and bipolar disorder.\n6. Known history of or self-reported active alcohol and\u002F or substance abuse within the past three years.\n7. Isolated living circumstances which would prohibit a study partner from providing sufficient and credible information about the participant.\n8. Poorly controlled hypertension\n9. Known Atrioventricular heart block, known heart block type I-III.\n10. History of myocardial infarction or signs or symptoms of unstable coronary artery disease within the last year (including revascularization procedure\u002Fangioplasty).\n11. Severe pulmonary disease (including chronic obstructive pulmonary disease) requiring more than 2 hospitalizations within the past year.\n12. Untreated obstructive sleep apnea.\n13. Any thyroid disease (unless euthyroid on treatment for at least 6 months prior to screening).\n14. Active neoplastic disease (except for skin tumors other than melanoma) within five years.\n15. Absolute lymphocytopenia of \\\u003C1,000\u002Fmm3, or a history of lymphocytopenia within the past two years.\n16. Absolute neutropenia of \\\u003C1,000\u002Fmm3, or a history of neutropenia within the past two years.\n17. History of\u002F or current thromboembolism (including deep venous thrombosis).\n18. Any clinically significant hepatic or renal disease (including presence of Hepatitis B or C surface antigen or an elevated transaminase levels of greater than 2x the upper limit of normal (ULN) or creatinine greater than 1.5 x upper limit of normal (ULN)).\n19. Clinically significant hematologic or coagulation disorder including any unexplained anemia, or a platelet count less than 100,000\u002FµL at screening.\n20. Use of any investigational drug within 30 days or within five half-lives of the investigational agent, whichever is longer.\n21. Unwilling or unable to undergo CT or MRI imaging.\n22. In the opinion of the investigator, participation would not be in the best interest of the subject.\n23. Subjects with CYP2C9\\*3\u002F\\*3 genotyping","50 Years","85 Years",{"count":73,"type":21},105,"INTERVENTIONAL",[76],"PHASE2","Collaboration with multiple sclerosis (MS) specialty colleagues led us to formulate the central hypothesis that Siponimod could lower the rate of brain atrophy in Alzheimer's disease (AD) subjects. To test our central hypothesis, we will carry out an 18-month Phase II, double-blind, randomized, twoarmed, placebo controlled, proof-of-concept clinical study in early AD subjects (i.e. mild AD) who will be receiving an escalating dose of Siponimod or placebo in the ratio 2:1 for 12 months, followed by a 6-month washout period. The primary outcome measures are safety and tolerability of Siponimod in mild AD subjects. The secondary outcome measures are the rates of brain atrophy derived from volumetric MRI (vMRI) as a proxy for neurodegeneration conducted at baseline, 6, 12, and 18 months. The tertiary outcome measures are the changes in cognition and the levels of AD-associated (e.g., Aβ and tau) and inflammatory biomarkers in CSF after Siponimod exposure. In an exploratory effort, we will also measure plasma inflammatory markers during the entire duration of the study to investigate whether one or more of these markers can be used as dynamic surrogate markers of treatment response. Using our unique experience with the repurposing of immunomodulatory drugs for AD (and NCT #04032626), in the present project we are using elements of clinical trial design that we believe were successful and made some adjustments to fit the pharmacologic and toxic properties of Siponimod.",[79,80,81,82],"Alzheimer Disease","Mild Alzheimer Disease","MCI With Increased Risk for Alzheimer Disease","Cognitive Impairment, Mild",[84,85,86,87,88,89,90],"Alzheimer's disease","Siponimod","Cognitive Impairment","Cognition","Brain Imaging","Biomarkers","Immunomodulation","2026-03-02",{"date":93,"type":34},"2026-03-04",{"date":95,"type":34},"2025-08-26",{"date":97,"type":21},"2029-10",{"name":40,"class":41},1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":74,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100521668","early-phase-1-a-phase-01-study-of-bdtx-1535-in-recurrent-high-grade-glioma-rhgg-and-newly-diagnosed-glioblastoma-ngbm-participants-with-egfr-alterations-or-fusions-100521668","NCT06072586","A Phase 0\u002F1 Study of BDTX-1535 in Recurrent High-Grade Glioma (rHGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions","A Phase 0\u002F1 Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK-triggered Expansion Cohort","Inclusion Criteria:\n\n* Arms A \\& B: Recurrent high grade glioma (2021 WHO Grades 3 and 4), defined as participants who have progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy.\n* Arm C, D, \\& E: Newly diagnosed glioblastoma (2021 WHO Grade 4), who have not received any tumor directed intervention other than biopsy or resection.\n* Candidate for clinical resection of rHGG (Arms A \\& B) or nGBM (Arms C \\& D).\n* Adequate archival or biopsy tissue available for testing of EGFR alterations. The tissue must have evidence of EGFR alterations including variants, fusion, and mutations with or without amplifications. rHGG participants with EGFR fusion will be solely enrolled into Arm B.\n* Participants must have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm.\n* Provision of signed and dated, written informed consent (personally or by the legally authorized representative, if applicable) prior to any study specific procedures, sampling and analyses.\n* Age ≥ 18 at time of consent\n* Have a performance status (PS) of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.\n* Ability to swallow oral medications.\n* Participant has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):\n\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Platelets ≥ 100,000\u002FmcL (at time of surgery)\n  * Hemoglobin ≥ 8.5 g\u002FdL (Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.)\n  * Total bilirubin ≤ 1.5 X ULN (Participants with Gilbert's syndrome with a total bilirubin ≤ 3.0 times ULN and direct bilirubin within normal limits are permitted.)\n  * AST (SGOT) ≤ 3 X institutional ULN\n  * ALT (SGPT) ≤ 3 X institutional ULN\n  * Serum creatinine ≤ 1.5 X ULN or estimated creatinine clearance ≥ 60 mL\u002Fmin (calculated using Institutional standard method)\n* Participants on corticosteroids at baseline must be on stable or decreasing doses for at least 5 days prior to Day 1.\n* Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause.\n* For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation until the end of treatment administration and for 16 weeks after the last dose of study drug.\n* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner until the end of treatment administration and for 16 weeks after the last dose of study drug.\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Known allergic reactions to components of the BDTX-1535.\n* Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis, as determined by the investigator.\n* Known active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics or fever \\>38.5°C at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening of viral infection is not required for enrollment.\n* Significant cardiovascular disease, including NYHA Class III or IV congestive heart failure, myocardial infarction, unstable angina, poorly controlled cardiac arrhythmias, or stroke in the preceding 6 months prior to study Day 1.\n* Symptomatic or radiographic leptomeningeal disease.\n* Participant has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n* Concurrent use of prohibited medications: coadministration of strong CYP2C8 and CYP3A4 inhibitors and inducers with BDTX-1535. These should be discontinued 1 week or 5 half-lives (whichever is greater) prior to study Day 1. Strong inhibitors of P-gp (e.g., Amiodarone, carvedilol, dronedarone, propafenone, quinidine, ranolazine, and verapami) and BCRP (e.g., curcumin, cyclosporin A, and eltrombopag) should be used with caution. Sensitive substrates of P-gp, BCRP, and OATP should also be used with caution.\n* Therapeutic intent treatment with another investigational drug or other intervention within 5 half-lives of the investigational product whichever is longer.\n* With the exception of alopecia, any unresolved toxicities from prior therapy greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5) Grade 1 at the time of starting study treatment and patients with chronic Grade 2 unresolved toxicities may be eligible following discussion with the Principal Investigator.",{"count":108,"type":21},82,[110],"EARLY_PHASE1","This study will administer the investigational drug, BDTX-1535 to eligible patients with recurrent high-grade glioma (HGG) and newly-diagnosed glioblastoma (nGBM). BDTX-1535 was designed to block a growth signal important to some cancers. BDTX-1535 is being tested in this study to see if it can be given safely to people who have tumors that can be dependent on that growth signal because of changes in a protein called EGFR. These gene changes are called amplifications, mutations, fusions or alterations and are found only in the tumors.\n\nThe study design includes a Phase 0 component with PK\u002FPD-trigger for participant enrollment into an Expansion Phase 1 component. The primary objective of the Phase 0 component is to evaluate the PK endpoints of BDTX-1535. The primary objective of the Phase 1 component is to establish the safe dose of BDTX-1535 to be used in participants with a specified treatment regimen, three of which include standard of care radiotherapy for nGBM participants.",[113,114],"High Grade Glioma","Glioblastoma","2025-11-17",{"date":117,"type":34},"2025-11-20",{"date":119,"type":34},"2023-10-18",{"date":121,"type":21},"2027-12",{"name":40,"class":41},2,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":74,"phases":133,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":99},"100541605","phase-4-gentamicin-bladder-instillation-on-cauti-100541605","NCT06332040","Gentamicin Bladder Instillation on CAUTI","A Randomized Controlled Trial to Evaluate the Effectiveness of Gentamicin Bladder Instillation on CAUTI","Inclusion Criteria:\n\n1. age greater than 18\n2. admitted with a trauma, surgical, or neuro-critical care diagnosis\n3. indwelling foley catheter in place\n\nExclusion Criteria:\n\n1. Documented positive UA or Urine Culture within the past 7 days or upon admission\n2. Traumatic bladder injury\n3. Gross hematuria\n4. Chronic indwelling urethral or chronic suprapubic foley catheter\n5. allergy to gentamicin or similar aminoglycosides",{"count":132,"type":21},400,[134],"PHASE4","Urinary tract infections in catheterized patients is an unacceptable complication and has been termed a 'never event' by the Center for Medicare \\& Medicaid Services (CMS); however there is not consensus among clinicians on how to best prevent CAUTIs. We propose a prospective randomized controlled trial to test the efficacy of prophylactic gentamicin bladder irrigation in elimination of CAUTIs.",[137],"Catheter Infection","2025-07-08",{"date":140,"type":34},"2025-07-11",{"date":142,"type":34},"2023-10-09",{"date":144,"type":21},"2026-10-08",{"name":40,"class":41},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":74,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":123},"100549062","time-restricted-eating-in-alzheimers-disease-100549062","NCT06429124","Time Restricted Eating in Alzheimer's Disease","Time-Restricted Eating in Alzheimer's Disease : The T.R.E.A.D Trial","TREAD","Inclusion Criteria:\n\n1. Male or Female outpatients 55-89 years of age.\n2. Meet Mayo Clinic Criteria for MCI.\n3. If taking medications that may affect one or more study outcome measures(such as donepezil and memantine),the participant must be on a stable dose for at least the preceding 3 months.\n4. A body mass index ≥18.5 and \\\u003C40.0 kg\u002Fm2.\n5. Access to the internet through computer or smartphone.\n6. Must have a collateral informant\u002Fstudy partner(e.g. spouse or adult child) who has significant direct contact with the patient and who is willing to accompany the patient to specified clinic visits and be available for telephone visits\u002FInterviews.\n7. An education level \\> 8 years.\n8. A proficiency in speaking and reading English or having a family member who is proficient in reading and speaking English and is willing to serve as a translator.\n9. Vision and hearing must be sufficient to comply with study procedures.\n\nExclusion Criteria:\n\n1. Diabetes mellitus that requires insulin treatment or is not well managed.\n2. An eating disorder.\n3. A contraindication to time-restricted eating.\n4. Daily eating window \\\u003C11 hours\u002Fday on ≥3 days\u002Fweek.\n5. MMSE score ≤9 or patients diagnosed with severe dementia by a clinician.\n6. In the opinion of the investigator, participation would not be in the best interest of the subject.\n7. Taking prescription medications twice a day that need to be taken with food.","55 Years","89 Years",{"count":157,"type":21},30,[159],"NA","This pilot and feasibility study will enable the research team to determine the feasibility of implementing a time-restricted eating regimen among adults with mild cognitive impairment (MCI) and the impact of time-restricted eating on cognitive performance and biomarkers of metabolic health in this population. Study staff will execute the specific aims using a pre-post, non-randomized study design in which all participants receive the intervention. The intervention is a 16\u002F8 time-restricted eating regimen characterized by fasting for 16 hours and eating within an 8-hour window on 5 days per week for 3 months. Assessments will be performed at baseline and after the 3-month time-restricted eating intervention with the following outcome measures.\n\nOutcome measures for feasibility include participant recruitment, retention and metrics of acceptability, safety, and adherence to the intervention. Outcome measures for cognitive performance and metabolic health include neuropsychological tests, blood biomarkers, and surveys of psychological well-being.",[162],"Mild Cognitive Impairment (MCI)",[164,165,166,167,168],"Alzheimer's Disease","Mild Cognitive Impairment","Intermittent Fasting","Nutritional Strategies","Time Restricted Eating","2025-06-03",{"date":171,"type":34},"2025-06-06",{"date":173,"type":34},"2023-03-15",{"date":175,"type":21},"2026-03-14",{"name":40,"class":41},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":16,"sex":17,"minAge":70,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":74,"phases":187,"briefSummary":188,"conditions":189,"keywords":194,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":4},"100529688","phase-2-mclena-2-a-phase-ii-clinical-trial-for-the-assessment-of-lenalidomide-in-patients-with-mild-cognitive-impairment-100529688","NCT06177028","MCLENA-2: A Phase II Clinical Trial for the Assessment of Lenalidomide in Patients With Mild Cognitive Impairment","MCLENA-2: A Phase II Clinical Trial for the Assessment of Biomarker Trajectory in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease Treated With Lenalidomide (Amendment to IND # 142121)","In order to be eligible for this study, subjects must meet the following inclusion criteria:\n\nInclusion Criteria:\n\n1. Male or female outpatients.\n2. At least 50 years of age, but less than 90 (89 at time of screening)\n3. Females must be surgically sterile (bilateral tubal ligation, oophorectomy, or hysterectomy) or postmenopausal for 2 years (no women at risk of pregnancy will be accepted in this study).\n4. Must have been diagnosed with amnestic MCI based on the most recent NIA-AA criteria (Albert et al., 2011), i.e. at both the screening and baseline visits (visits 1 and 2) have a documented Mini Mental State Exam (MMSE) score between 22-28.\n5. CT or MRI scan of the brain obtained during the course of the dementia must be consistent with the diagnosis and show no evidence of significant focal lesions or of pathology which could contribute to dementia. If neither a CT nor an MRI scan is available from the past 12 months, a CT scan fulfilling the requirements must be obtained before randomization.\n6. Vision and hearing must be sufficient to comply with study procedures.\n7. Be able to take oral medications.\n8. Hachinski ischemic score must be ≤ 4.\n9. Geriatric depression scale must be ≤ 10.\n10. Can be on stable doses of a cholinesterase inhibitor and\u002For memantine as long as it is stable for at least 90 days before screening and is expected to remain on a stable dose for the remainder of the study period; or have demonstrated intolerance to or lack of efficacy from these medications.\n11. Must have a collateral informant\u002Fstudy partner who has significant direct contact with the patient at least 10 hours per week and who is willing to accompany the patient to specified clinic visits, supervise administration of all study medication, and be available for telephone visits\u002Finterviews.\n12. If the patient has a legally authorized representative (LAR), the LAR must review and sign the informed consent form. If the patient does not have an LAR, the patient must appear able to provide informed consent and must review and sign the informed consent form. In addition, the patient's informant\u002Fstudy partner (as defined above) must sign an informed consent form. If the LAR and the patient's informant \u002Fstudy partner is the same individual, he\u002Fshe should sign under both designations.\n13. Must reside in the community.\n14. Patients with stable prostate cancer may be included at the discretion of the Medical Monitor.\n15. Positivity for amyloid brain scan: Amyloid PET positive at SUVr of 1.05\n\nExclusion Criteria:\n\nSubjects will be excluded if they have any of the condition listed below:\n\n1. Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including (but not limited to) epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, head injury with loss of consciousness\n2. DSM IV criteria for any major psychiatric disorder including psychosis, major depression and bipolar disorder.\n3. Unwilling or unable to undergo a Lumbar Puncture.\n4. Known history or self-reported alcohol or substance abuse.\n5. Living alone.\n6. Poorly controlled hypertension. 7 .History of myocardial infarction or signs or symptoms of unstable coronary artery disease within the last year (including revascularization procedure\u002Fangioplasty).\n\n8\\. Severe pulmonary disease (including chronic obstructive pulmonary disease) requiring more than 2 hospitalizations within the past year.\n\n9\\. Untreated sleep apnea. 10. Any thyroid disease (unless euthyroid on treatment for at least 6 months prior to screening).\n\n11\\. Active neoplastic disease (except for skin tumors other than melanoma) within five years.\n\n12\\. History of multiple myeloma. 13. Absolute neutropenia of \\\u003C750\u002Fmm3, or a history of neutropenia. 14. History of or current thromboembolism (including deep venous thrombosis). 15. Any clinically significant hepatic or renal disease (including presence of Hepatitis B or C antigen\u002Fantibody or an elevated transaminase levels of greater than two times the upper limit of normal (ULN) or creatinine greater than 1.5 x ULN).\n\n16\\. Clinically significant hematologic or coagulation disorder including any unexplained anemia or a platelet count less than 100,000\u002FμL at screening.\n\n17\\. Use of any investigational drug within 30 days or within five half-lives of the investigational agent, whichever is longer.\n\n18\\. Use any investigational medical device within two weeks before screening or after end of the present study.\n\n19\\. Females who are at risk of pregnancy or are of child bearing age. 20. Unwilling or unable to undergo MRI and PET imaging. 21. Cardiac pacemaker or defibrillator or other implanted device. 22. In the opinion of the investigator, participation would not be in the best interest of the subject","90 Years",{"count":186,"type":21},45,[76],"This is a randomized, double-blind, placebo-controlled, parallel group study. The use of placebo is appropriate to minimize bias related to treatment expectations of the subject, study partner, and site investigator, as well as to changes in the relationship between the subject and study partner that might occur with the initiation of treatment and expectation of improvement in motor symptoms or cognition. Changes in subject\u002Fstudy partner interactions can impact subject mood and might introduce biases that cannot be quantified. The double-blind use of placebo will also prevent bias in the clinical and scientific assessments.",[82,190,191,192,193],"Cognitive Dysfunction","Amyloid Plaque","Neurodegenerative Disease, Hereditary","Inflammation, Brain",[84,195,89,88,196,197,90],"CSF","Brain Amyloid","Memory Loss","NOT_YET_RECRUITING","2025-05-14",{"date":201,"type":34},"2025-05-18",{"date":203,"type":21},"2025-06-01",{"date":205,"type":21},"2027-01-02",{"name":40,"class":41},{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":17,"minAge":70,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":74,"phases":216,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":99},"100572516","working-memory-training-in-patients-with-mild-cognitive-impairment-100572516","NCT06734286","Working Memory Training in Patients with Mild Cognitive Impairment","CogMed Intervention Targeting Working Memory in Patients with Mild Cognitive Impairment","Inclusion Criteria:\n\n1. Male or female outpatients ages ≥ 50 years;\n2. Meet Mayo Clinic Criteria for MCI. (Patients with mild cognitive impairment)\n3. Access to the internet through computer\n4. A proficiency in speaking and reading English or having a family member who is proficient in reading and speaking English and is willing to serve as a translator.\n5. Vision and hearing must be sufficient to comply with study procedures.\n\nExclusion Criteria:\n\n1. Mini Mental State Exam (MMSE) score less than 19 or patients diagnosed with moderate or severe dementia by a clinician.\n2. In the opinion of the investigator, participation would not be in the best interest of the subject.",{"count":215,"type":21},10,[159],"The purpose of this study is to test whether a special memory training program, called CogMed, can help people with early memory problems. The Investigators want to see if this training improves memory and also helps reduce stress.\n\nThe Investigators also want to see if CogMed results in changes to a blood biomarker called p-Tau 217, which possibly indicate Alzheimer's disease (AD).",[162],[220,221,222,223,224,164],"CogMed","Mild cognitive Impairment","CogMed intervention targeting working memory","CogMed Intervention Vs Treatment as Usual","working memory training","2024-12-12",{"date":227,"type":34},"2024-12-16",{"date":229,"type":34},"2024-09-16",{"date":231,"type":21},"2025-09-30",{"name":40,"class":41},{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":74,"phases":244,"briefSummary":245,"conditions":246,"keywords":249,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":99},"100286902","phase-4-prophylactic-oral-antibiotics-on-sinonasal-outcomes-following-endoscopic-transsphenoidal-surgery-for-pituitary-lesions-100286902","NCT03014687","Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions","A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Impact of Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions","POET","Inclusion Criteria:\n\n* Adult patient undergoing endoscopic surgery for resection of pituitary tumors for nonfunctioning adenoma, acromegaly, or prolactinoma\n* Adults \\>18 and \\\u003C85 years of age\n* English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales\n* Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable\n\nExclusion Criteria:\n\n* Anaphylaxis\u002Fintolerance to the study drugs\n* Cirrhosis, hepatitis\n* Any solid organ transplant or bone marrow transplant. And any patient felt to be immunocompromised by the investigators\n* Renal failure on dialysis\n* Any subject who is unwilling or unable to sign informed consent for the study\n* Pregnancy\n* Incarcerated patients\n* Cushing's disease\n* Rathke's Cleft cyst or pituitary cyst\n* History of chronic sinusitis\n* Anticipated use of nasal splints\n* Anticipated use of nasal septal flap\n* Active sinusitis\n* Nasal polyps\n* Previous sinus surgery\n* Concurrent antibiotics for another indication (i.e., urinary tract infection)\n* Immunodeficiency","84 Years",{"count":243,"type":21},116,[134],"To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection (sinusitis), and helps mucosal healing in the nasal passages.",[247,248],"Antibiotics","Pituitary Adenoma",[250],"transsphenoidal surgery","2018-08-13",{"date":253,"type":34},"2018-08-15",{"date":255,"type":34},"2017-07-01",{"date":257,"type":21},"2019-07",{"name":40,"class":41},""]