[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mild-alzheimer-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mild-alzheimer-disease":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100565215","phase-2-repurposing-siponimod-for-alzheimers-disease-100565215",false,"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","ALL","50 Years","85 Years",{"count":21,"type":22},105,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Alzheimer Disease","Mild Alzheimer Disease","MCI With Increased Risk for Alzheimer Disease","Cognitive Impairment, Mild",[33,34,35,36,37,38,39],"Alzheimer's disease","Siponimod","Cognitive Impairment","Cognition","Brain Imaging","Biomarkers","Immunomodulation","RECRUITING","2026-03-02",{"date":43,"type":44},"2026-03-04","ACTUAL",{"date":46,"type":44},"2025-08-26",{"date":48,"type":22},"2029-10",{"name":50,"class":51},"St. Joseph's Hospital and Medical Center, Phoenix","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":52},"100606385","a-study-to-assess-the-feasibility-of-indivi-mobile-application-in-monitoring-cognitive-performance-in-aging-population-100606385","NCT07174869","A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population","A Pilot Study To Assess The Dynamic Difficulty Adjustment In Personalized Testing For Persons With MCI And Matched Healthy Controls","ADAPT-MCI-01","Inclusion Criteria:\n\n* Participant is part of BU-ADRC cohort.\n* Participant is diagnosed with MCI, mild AD, or is classified as HC per BU-ADRC, with available required data for inclusion obtained less than 2 years before the inclusion.\n* Participant is between 50 and 90 years old, included.\n* Participant is able to use a smartphone.\n* Participant has sufficient knowledge of the English language.\n* Participant is able to and has an intention to follow the study procedures.\n* Informed Consent as documented by signature.\n\nExclusion Criteria:\n\n* Participant has any neurological condition that may be contributing to cognitive impairment (above and beyond that caused by the subject's MCI or AD).\n* Participant has psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures.\n* Participant has a history of stroke or seizures within the last 24 months.\n* Participant has a Geriatric Depression Scale (GDS) score ≥8.\n* Participant has a severe visual or hearing impairment that would interfere with capacity to perform cognitive assessments.\n* Known or suspected non-compliance.",true,"90 Years",{"count":64,"type":22},55,"OBSERVATIONAL","The goal of this observational study is to evaluate the functionality and usability of Indivi mobile application-based cognitive activities in people with mild cognitive impairment\u002Fmild Alzheimer's disease (PwMCI\u002FAD) and healthy controls (HC). This application uses a dynamic difficulty adjustment (DDA) system that customizes the level of the cognitive activities to each user.\n\nThe main questions it aims to answer are:\n\n* Does the DDA system reach a stable difficulty level at the same rate for both PwMCI\u002FAD and HC?\n* Is the stable difficulty level reached by the DDA system different for PwMCI\u002FAD compared to HC?\n\nResearchers will also compare cognitive activities results and other aspects of the mobile application's performance to see if the application can validly distinguish between the two groups.\n\nParticipants will use the Indivi mobile application, with its embedded DDA system, for a 6-week period.",[68,29],"Mild Cognitive Impairment (MCI)","2025-09-09",{"date":71,"type":44},"2025-09-16",{"date":73,"type":22},"2025-09",{"date":75,"type":22},"2026-06",{"name":77,"class":78},"Indivi AG","INDUSTRY",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":103,"locationsCount":52},"100567640","itbs-in-mci-and-mild-ad-100567640","NCT06670820","iTBS in MCI and Mild AD","The Effects of Intermittent Theta-burst Stimulation on Cognitive Function in Patients With Mild Cognitive Impairment and Mild Alzheimer's Disease and the Role of Brain-Derived Neurotrophic Factor","Inclusion Criteria:\n\n* Clinical diagnosis of MCI (overall Clinical Dementia Rating of 0.5)\n* Clinical diagnosis of mild Alzheimer's Disease (overall Clinical Dementia Rating of 0.5 or 1)\n\nExclusion Criteria:\n\n* History of stroke\n* History of uncontrol seizure\n* History of significant head trauma followed by persistent neurologic deficit or known structural brain abnormality\n* Mental illness\n* Drug abuse",{"count":87,"type":22},80,[89],"NA","This study aims to examine the effects of iTBS on cognitive function in individuals with MCI or mild AD, with a secondary objective of exploring prefrontal TBS mechanisms for cognitive function and the effect of iTBS on BDNF.",[68,29],[93,94,95,29],"rTMS","iTBS","Mild Cognitive Impairment","NOT_YET_RECRUITING","2024-10-31",{"date":99,"type":44},"2024-11-01",{"date":97,"type":22},{"date":102,"type":22},"2028-12-31",{"name":104,"class":51},"National Defense Medical Center, Taiwan"]