[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alzheimer-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alzheimer-disease":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,375,0,25,[9,42,75,99,121,146,171,196,217,227,249,260,277,300,331,348,374,426,448,467,491,515,543,563,584],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053295","phase-3-a-phase-3-study-to-evaluate-the-safety-and-efficacy-of-karxt--karx-ec-for-the-treatment-of-agitation-associated-with-alzheimers-disease-adagio-1-100053295",false,"NCT07011732","A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease","Inclusion Criteria\n\n\\- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42\u002F40 ratio in CSF, pTau181\u002FAβ42 ratio in CSF or pTau217\u002FAβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.\n\nii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.\n\nB. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:\n\n* Amyloid PET.\n* Aβ42\u002F40 ratio or pTau181\u002FAβ42 ratio in CSF using an HA-authorized diagnostic assay.\n\n  * Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1).\n  * Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:\n\n    i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study.\n  * History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).\n  * AD participants are required to have NPI\u002FNPI-NH Agitation\u002FAggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).\n  * CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).\n\nExclusion Criteria\n\n\\- Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.\n\nii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.\n\niv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and\u002For C-SSR.\n\n\\- Prior\u002FConcomitant Therapy: i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).\n\nA. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.\n\nB. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).\n\nC. Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).\n\n\\- Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","55 Years","90 Years",{"count":21,"type":22},426,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.",[28],"Alzheimer Disease","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2025-07-10",{"date":37,"type":22},"2028-12-08",{"name":39,"class":40},"Bristol-Myers Squibb","INDUSTRY",158,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100053654","phase-2-trial-of-cort108297-to-attenuate-the-effects-of-acute-stress-in-the-allocortex-cort-x-100053654","NCT04601038","Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X)","Phase II Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X)","CORT-X","Individuals must meet criteria for mild cognitive impairment due to Alzheimer's disease according to National Institute on Aging (NIA)\u002FAlzheimer's Association recommendations OR be cognitively normal based on clinical and cognitive assessment in the Enrollment Visit and have at least one of the following risk factors for AD:\n\n* Known to have at least 1 apolipoprotein E (APOE) ε4 allele;\n* Subjective cognitive concerns with a T score \\\u003C 40 on the Multifactorial Memory Questionnaire Satisfaction Scale;\n* A first-degree relative with dementia.\n\nInclusion Criteria for all subjects:\n\n* At least 55 years of age;\n* Body mass index \\>17 and \\\u003C30;\n* Post-menopausal (if female)\n* Non-smoker;\n* Availability of a study partner who has frequent contact with the subject (10+ hours\u002Fweek in person and by telephone), and is able to provide an independent evaluation of functioning;\n* Fluent English speaker;\n* Good general health with no disease expected to interfere with the study;\n* Willing and able to participate for the duration of the study.\n\nExclusion Criteria for all subjects:\n\n* Participation in a therapeutic clinical trial at any time during the study;\n* Abnormal corrected QT interval using Bazett's formula (QTcB; defined as \\> 450 ms for men and \\> 470 ms for women) as determined on ECG;\n* Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities, including lacunes in critical memory structures including the hippocampus and parahippocampal cortex;\n* Bipolar disorder within the past 1 year;\n* History of alcohol or drug dependence;\n* Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol;\n* General surgery within the last 3 months;\n* Sensory impairment (poor vision or hearing) significant enough to interfere with ability to provide valid cognitive test data;\n* Treatment within the last six months with neuroleptics, sedative hypnotics, or glucocorticoids;\n* Treatment within the last six months with medications metabolized by the CYP2C9 or CYP2C19 enzymes, most notably clopidogrel and proton pump inhibitors;\n* Concurrent use of a CYP3A inhibitor, including grapefruit juice, and St. John's Wort;\n* Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the PI.",true,{"count":52,"type":22},52,[54],"PHASE2","CORT-X will examine if mitigation of stress-mediated pathogenesis of Alzheimer's disease (AD) is a feasible target for intervention in individuals at risk for this disease. This single-site (Baltimore, Maryland) phase II clinical trial is a 2-week, randomized, placebo-controlled crossover study of the effects of the selective glucocorticoid receptor antagonist, CORT108297, on cognitive test performance in 26 individuals with mild cognitive impairment (MCI) due to AD and in 26 cognitively normal individuals with an increased risk for AD due to family history, genetics, and\u002For subjective memory complaints. All subjects will participate in a brief stressor (public speaking and mental arithmetic) and provide saliva samples so investigators can measure stress hormone response. Then, following 2 weeks of treatment with placebo or CORT108297, in counterbalanced order, participants will complete cognitive tests assessing memory and executive function. All study participants will receive CORT108297 and placebo over the course of this 10-week trial that requires 6 in-person study visits. The primary aims will compare the effects of CORT108297 to placebo on cognitive test performance in individuals with MCI due to AD and in individuals at risk for AD, and describe the side effects of CORT108297 in study participants. Secondary aims will identify subject characteristics that predict positive response to study drug.",[57,28,58],"Mild Cognitive Impairment","Memory Impairment",[60,61,62,63,64,65],"Stress","Memory loss","Dementia","Alzheimer's disease","Cognitive","Impairment",{"date":32,"type":33},{"date":68,"type":33},"2021-06-28",{"date":70,"type":22},"2028-01-01",{"name":72,"class":73},"Johns Hopkins University","OTHER",1,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":50,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":74},"100053998","phase-2-dora-and-lp-in-alzheimers-disease-biomarkers-100053998","NCT06274528","DORA and LP in Alzheimer's Disease Biomarkers","Effect of a Dual Orexin Receptor Antagonist on CSF Alzheimer's Disease Biomarkers","Inclusion Criteria:\n\n* Male or female.\n* Any race or ethnicity.\n* Participants must be age ≥ 65 years and able to sign informed consent.\n* Global Clinical Dementia Rating (CDR) 0.\n* Willing and able to undergo study procedures.\n\nExclusion Criteria:\n\n* History or reported symptoms suggestive of restless legs syndrome, narcolepsy, or parasomnia.\n* STOP-Bang score \\>6 for participants without PAP.\n* Untreated sleep apnea AHI\\>15\n* Poorly treated sleep apnea due to noncompliance or an AHI ≥ 10.\n\n  \\- PAP compliance is defined as ≥ 4 hours per night \\>70% of the nights.\n* Plasma p-Tau217\u002Fnp-Tau217% \\\u003C2.5\n* Stroke.\n* History of renal impairment\n\n  * Defined as older adult patients with markers of kidney damage or eGFR \\\u003C 45.0 ml\u002Fmin\u002F1.73m2.\n  * Normal Limits ≥ 45.0 mL\u002Fmin\u002F1.73m2\n* History of hepatic impairment\n\n  * AST and\u002For ALT ≥ 2X upper limit of normal (ULN).\n  * Normal Limits: AST 11-47 IU\u002FL and ALT 6-53 IU\u002FL\n* HIV\u002FAIDS.\n* History of substance abuse or alcohol abuse in the preceding 6 months.\n* Regular alcohol consumption 3 or more days a week over the last 6 months. Regular alcohol consumption is defined as having more than 2 alcoholic beverages within 3 hours of bedtime. Participants that agree to reduce alcohol consumption during the study may not be excluded.\n* History of presence of any clinically significant medical condition, behavioral or psychiatric disorder, or surgical history based on medical record or participant report that could affect the safety of the participant or interfere with study assessments or in the judgement of the Principal-Investigator (PI) if participant is not a good candidate.\n* Has any medical condition that, in the PI's or study team investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection\u002Fanalysis of the data. Potential medical conditions that will be exclusionary at the PI's or study team investigator's discretion:\n\n  * Cardiovascular disease requiring medication except for controlled hypertension.\n  * Pulmonary disease.\n  * Type I diabetes.\n  * Neurologic or psychiatric disorder requiring medication.\n  * Untreated depression\n  * Tobacco use.\n  * Use of sedating medications.\n  * Use of medications that interact with lemborexant (if cannot be discontinued).\n  * Abnormal safety labs.\n* History of current suicidal ideations.\n* Inability to speak and understand English.\n* Currently pregnant or breast-feeding.\n* In the opinion of the PI, the participant should be excluded due to an abnormal physical examination.\n* Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment.\n* Must not participate in another drug or device study prior to the end of this study participation.\n\nOptional assessment exclusion criteria:\n\n• Contraindication to lumbar puncture (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery).","65 Years",{"count":84,"type":22},201,[54],"The purpose of this study is to see if the sleep aid, lemborexant, can decrease the amount of amyloid-beta and tau in the blood. Amyloid-beta and tau are proteins involved in the disease process leading to Alzheimer's disease.",[28],[89,90,91],"Sleep","Older Adults","DORA",{"date":32,"type":33},{"date":94,"type":33},"2024-03-11",{"date":96,"type":22},"2030-03-31",{"name":98,"class":73},"University of Minnesota",{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":50,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":74},"100053331","phase-2-sleep-trial-to-prevent-alzheimers-disease-100053331","NCT04629547","Sleep Trial to Prevent Alzheimer's Disease","SToP-AD","Inclusion Criteria:\n\n* Male or female.\n* Any race or ethnicity.\n* Participants must be age ≥65 years and able to sign informed consent.\n* Global Clinical Dementia Rating (CDR) 0.\n* Willing and able to undergo study procedures.\n\nExclusion Criteria:\n\n* History of reported symptoms suggestive of restless legs syndrome, narcolepsy or other central disorder of hypersomnolence, or parasomnia\n* STOP-Bang score \\>6 for participants without PAP\n* Untreated OSA with AHI ≥15 on home sleep test\n* Treated sleep apnea with PAP non-compliance\n\n  * PAP compliance is defined as \\>= 4 hours per night \\>70% of the nights\n* Plasma A-beta and tau test with a plasma p-tau 217% ≤ 1.19\n* Stroke.\n* Chronic kidney disease defined as patients with markers of kidney damage or eGFR of \\\u003C 45 ml\u002Fmin\u002F1.73m2.\n* Hepatic impairment defined as AST and\u002For ALT \\> 2x upper limit of normal (normal limits AST: 11-47 IU\u002FL, ALT: 6-53 IU\u002FL).\n* HIV\u002FAIDS.\n* History of substance abuse or alcohol abuse in the proceeding 6 months.\n* Regular alcohol consumption 3 or more days a week over the last 6 months. Regular alcohol consumption is defined as having more than 2 alcoholic beverages within 3 hours of bedtime. Participants that agree to reduce alcohol consumption during the study may not be excluded.\n* History of presence of any clinically significant medical condition, behavioral or psychiatric disorder, or surgical history based on medical record or participant report that could affect the safety of the participant or interfere with study assessments or in the judgement of the Principal-Investigator (PI) if participant is not a good candidate.\n* Has any medical condition that, in the PI's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection\u002Fanalysis of the data. Potential medical conditions that will be exclusionary at the PI's discretion:\n\n  * Cardiovascular disease requiring medication except for controlled hypertension.\n  * Pulmonary disease.\n  * Type I diabetes.\n  * Neurologic or psychiatric disorder requiring medication.\n  * Tobacco use.\n  * Use of sedating medications.\n  * Use of medications that interact with suvorexant (if cannot be discontinued)\n  * Abnormal safety labs\n* History of current suicidal ideations.\n* Currently pregnant or breast-feeding.\n* In the opinion of the PI, the participant should be excluded due to an abnormal physical examination.\n* Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment.\n* Must not participate in another drug or device study prior to the end of this study participation.\n\nExclusion criteria for optional lumbar punctures\n\n-• Contraindication to lumbar puncture (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery).",{"count":107,"type":22},120,[54],"The purpose of this study is to determine if treatment with the sleep aid suvorexant can decrease the rate of amyloid-β (Aβ) accumulation in the brain.",[89,28],[112,113,114],"poor sleep","Amyloid-Beta","Insomnia",{"date":32,"type":33},{"date":117,"type":33},"2022-05-25",{"date":119,"type":22},"2028-05",{"name":98,"class":73},{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":50,"sex":17,"minAge":128,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":23,"phases":131,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":74},"100624754","phase-2-the-gut---pro-study-100624754","NCT07413744","The Gut - PRO Study","Probiotic Supplementation Safety and Feasibility Study in Preclinical Alzheimer's Disease","Inclusion Criteria:\n\n* MCI\u002FAD or cognitively unimpaired, referred from a Wisconsin clinic that is part of the Wisconsin Alzheimer's Institute's (WAI) network, or recruited from the community. May have participated in:\n\n  * Alzheimer's Disease Research Center (ADRC) clinical core study (2011-0030)\n  * ADCP (26695, MCW IRB)\n  * Synapse study (2018-1283)\n  * ADRC Recruitment Registry (2016-0735)\n* At least 60 years of age or older\n* Good general health (other than cognitive impairment\u002Fdementia) with no conditions\u002Fmedications affecting the gut microbiome (see exclusion criteria below)\n* Willing and able to comply with all study procedures for the duration of the study\n* Able to provide signed and dated informed consent form\n* Participant is not pregnant, lactating or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)\n* Able to take oral medications\n* An informant to answer questionnaires about the participant\n\nAdditional inclusion criteria for unimpaired participants:\n\n* Has MOCA score that falls within the range defined for cognitively healthy individuals\n\nAdditional inclusion criteria for participants with MCI\u002FAD\n\n* Abnormal cognitive function documented by neuropsychological testing\n* ADRC (2015-0030) Consensus Diagnosis Conference indicates dementia or MCI due to AD (for ADRC, ADCP, and Synapse participants only)\n* Meets NIA-AA criteria for MCI or AD.\n\nExclusion Criteria:\n\n* Active or previous (within 6 months) participation in an Alzheimer's clinical intervention\u002Ftrial (can be included if previously enrolled in placebo or control group)\n* Standard clinical care for dementia and medications used to treat MCI and Alzheimer's disease are acceptable, including monoclonal antibody therapy\n* Significant neurologic disease: Any significant neurologic disease, such as Parkinson's disease, stroke, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, subdural hematoma, multiple sclerosis, seizure disorder, or other significant deficits other than Alzheimer's or Mild Cognitive Impairment\n* Alcohol\u002Fsubstance: history of alcohol\u002Fsubstance dependence in the past year.\n* Significant medical illness: any significant systemic illness or unstable medical condition occurring during ADRC participation that could affect cognition (other than MCI\u002FAD). Examples include malignant cancer, chemotherapy, HIV, untreated thyroid disease, heart failure, or renal insufficiency\n* Current diagnosis with diabetes\n* Illiterate, blind, or non-English speaking\n* Known periodic antibiotic use (i.e., prior to dental appointments)\n* Oral PS-specific exclusion criteria:\n\n  * Inability (e.g., dysphagia) or unwilling to swallow capsules\n  * Active gastrointestinal infection at time of enrollment\n  * Known or suspected toxic megacolon and\u002For known small bowel ileus\n  * History of total colectomy or bariatric surgery\n  * Concurrent intensive induction chemotherapy, radiation therapy, or biological treatment for active malignancy\n  * Unable or unwilling to comply with protocol requirements\n  * Expected life expectancy less than 6 months\n  * Previous use of probiotic supplementation (PS) or microbiome-based products within 2 months, large doses of commercial probiotics consumed (greater than or equal to 10\\^8 cfu or organisms per day). Includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component (ordinary dietary components such as fermented beverages\u002Fmilks, yogurts, foods do not apply). Enrollment after 2 months without probiotic use can be considered for eligibility\n  * Patients with severe anaphylactic or anaphylactoid food allergy\n  * Solid organ transplant recipients less than or equal to 90 days post-transplant or on active treatment for rejection\n  * A condition that would jeopardize the safety or rights of the participant, would make it unlikely for the participant to complete the study, or would confound the results of the study\n* Exclusionary factors affecting the microbiome:\n\n  * Previous use of systemic antibiotics (intravenous, intramuscular, or oral) within 3 months (depends on the duration of antibiotic use, i.e., less than 3 months is considered exclusion, however, enrollment after 3 months without antibiotic use can be considered for eligibility)\n  * Immune stimulating and\u002For suppressing medications\n  * Immunosuppressed as evaluated by complete blood count (CBC) with differential, which includes white blood cell count, total neutrophil count, and total lymphocyte count\n  * Unstable dietary history during the previous month, which is defined as major changes in diet by eliminating or significantly increasing a major food group\n  * Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years\n  * Major bowel resection at any time\n  * Active uncontrolled gastrointestinal disorders or disease including inflammatory bowel disease, ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis; irritable bowel syndrome (moderate-severe); persistent, infectious gastroenteritis, colitis, or gastritis; persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated), or chronic constipation","60 Years",{"count":130,"type":22},40,[54],"The purpose of this study is to assess the safety and feasibility of an oral probiotic supplement (PS) intervention in individuals with dementia or mild-cognitive impairment (MCI) due to Alzheimer's disease or at risk of dementia due to Alzheimer's disease (AD). 40 participants will be enrolled and can expect to be on study for up to 1 year.",[28],[135],"probiotics","NOT_YET_RECRUITING","2026-06-30",{"date":139,"type":33},"2026-07-02",{"date":141,"type":22},"2026-08",{"date":143,"type":22},"2029-03",{"name":145,"class":73},"University of Wisconsin, Madison",{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":155,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100588118","phase-3-a-study-to-evaluate-the-long-term-efficacy-and-safety-of-karxt--karx-ec-for-agitation-in-alzheimers-disease-adagio-3-100588118","NCT06937229","A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)","A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)","Inclusion Criteria:\n\n* Participants must have completed study CN012-0023 or CN012-0024 per protocol.\n* Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).\n\nExclusion Criteria:\n\n* Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":154,"type":22},650,[25],"The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate\u002Ftrospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.",[28,158],"Agitation",[158,160,161,162],"Alzheimer disease","KarXT","KarX-EC",{"date":164,"type":33},"2026-07-01",{"date":166,"type":33},"2025-12-02",{"date":168,"type":22},"2029-07-20",{"name":39,"class":40},256,{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},"100588940","phase-3-a-study-to-evaluate-safety-and-efficacy-of-karxt--karx-ec-as-a-treatment-for-psychosis-associated-with-alzheimers-disease-adept-5-100588940","NCT06947941","A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)","A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Psychosis Associated With Alzheimer's Disease","Inclusion Criteria:\n\n* Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).\n* Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer's Association Workgroup.\n* Participants must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.\n* Participants must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).\n\nExclusion Criteria:\n\n* Participants must not have psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.\n* Participants must not have history of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.\n* Participants must not have certain safety concerns, including certain laboratory test irregularities.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":179,"type":22},325,[25],"The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.",[28,183],"Psychosis",[160,63,185,62,183,186,187],"Alzheimer's","Alzheimer's disease psychosis","Alzheimer's disease psychosis with or without agitation","2026-06-29",{"date":137,"type":33},{"date":191,"type":33},"2026-03-25",{"date":193,"type":22},"2028-03-20",{"name":39,"class":40},22,{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":4},"100501488","phase-3-tricaprilin-phase-3-alter-ad-alternative-alzheimer-disease-study-100501488","NCT05809908","Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study","A Phase 3, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-OLE-01-VA in Participants With Mild to Moderate Alzheimer's Disease Dementia","ALTER-AD","Key Inclusion Criteria:\n\n* Mini Mental State Exam (MMSE) score between 14 to 24\n* Meets diagnostic clinical criteria of probable Alzheimer's disease dementia according to the NIA-AA criteria\n* Magnetic resonance imaging (MRI) scan less than 12 months before Baseline compatible with a diagnosis of probable AD\n* Plasma biomarker result supporting a diagnosis of AD before Baseline (Aβ42\u002F40 and\u002For pTau217)\n* Confirmed APOE4 genotype result prior to Baseline\n* Participants taking the following cholinesterase inhibitors: donepezil, galantamine, or rivastigmine; and\u002For sodium oligomannate (GV-971), and\u002For memantine, and\u002For GLP-1 antagonist and\u002For other agents which may impact cognition are eligible for enrolment: a) If the participant has been taking such medication(s)\u002Fproducts for 3 months or more at Screening Visit 1; b) If the current dosage regimen is within the approved dose range; c) The daily dose has remained unchanged for at least 6 weeks prior to screening; d) If the dose is not expected to change during study participation\n\nKey Exclusion Criteria:\n\n* Has any medical\u002Fneurological\u002Fpsychiatric condition, other than AD, that could explain the participant's dementia or cognitive impairment, such as but not limited to e.g., structural abnormality, traumatic brain injury, stroke, epilepsy, Parkinson's disease, alcohol-related dementia, current major depressive episode\n* The following GI conditions are exclusionary: a) Inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), GI bleed (upper or lower), or peptic ulcer disease; any of these conditions are exclusionary, if active in the past 5 years. Participants with remote quiescent disease, at the Investigators discretion , are not excluded; b) Participants with current or a history of (within the last 5 years) any of the following conditions are excluded: clinically significant reflux disease (e.g., Barrett's oesophagus, stricture, ulcer, haemorrhage), or severe gastroesophageal reflux disease that, in the opinion of the Investigator, is not well-controlled by medication; c) Irritable bowel syndrome, diverticular disease (e.g., diverticulosis, or diverticulitis), or chronic gastritis; any of these conditions are exclusionary if there has been an acute event within 1 year prior to Screening; d) History of gastric food intolerance, whether it be allergy or chronic oversensitivity, or a history of stomach upset reaction to a variety of foods\n* Current or previous treatment with any anti-amyloid or anti-Tau antibodies such as lecanemab and donanemab within 6 months prior to the day of screening","85 Years",{"count":206,"type":22},535,[25],"The purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, global function, activities of daily living, resource utilisation, safety, and tolerability, in participants with mild to moderate AD dementia.\n\nThis is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre design in up to 535 participants.",[28],{"date":164,"type":33},{"date":212,"type":22},"2026-12",{"date":214,"type":22},"2029-07",{"name":216,"class":40},"Cerecin",{"id":218,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":220,"briefSummary":26,"conditions":221,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":225,"leadSponsor":226,"locationsCount":41},"100593845",{"count":21,"type":22},[25],[28],"2026-06-26",{"date":137,"type":33},{"date":35,"type":33},{"date":37,"type":22},{"name":39,"class":40},{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":248},"100636859","phase-3-donanemab-ly3002813-trial-in-chinese-participants-with-cognitively-unimpaired-preclinical-alzheimers-disease-100636859","NCT07571161","Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease","A Study of Donanemab Versus Placebo in Chinese Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease","Inclusion Criteria:\n\n* A Telephone Interview for Cognitive Status - Modified (TICS-M) score indicative of intact cognitive function (cut-off score of 35 or higher)\n* Clinical Dementia Rating-Global Score (CDR-GS) of 0\n* A plasma P-tau result consistent with amyloid pathology\n* A reliable study partner who:\n\n  * Provides written informed consent to participate in the study in their role\n  * Has frequent contact with the participant and is familiar with their overall function and behavior, including daily activities and cognitive abilities\n  * Is of legal age (18 years of age or older) to consent\n  * Is available to conduct functional scales\n* Have adequate literacy, vision, and hearing for neuropsychological testing\n\nExclusion Criteria:\n\n* Have mild cognitive impairment (MCI), dementia, or other significant neurodegenerative diseases that could affect cognition\n* Have a serious or unstable illness (including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease, or other condition) that, in the investigator's opinion, could interfere with study analyses or result in a life expectancy of 5 years or fewer\n* Have received active or passive immunization against amyloid beta (Aβ) in any other study\n* Have current or prior use of prescription medications for treatment of MCI or AD\n* Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants or other accessory medical devices, such as cardiac pacemakers, stents, and cochlear implants\n* Have a centrally read magnetic resonance imaging (MRI) demonstrating the presence of Amyloid-related imaging abnormalities (ARIA-E), more than 4 cerebral microhemorrhages, more than 1 area of cortical superficial siderosis, any macrohemorrhage (that is, intracerebral hemorrhage more than 1 cm), or severe white matter disease at screening","80 Years",{"count":236,"type":22},140,[25],"The main purpose of this study is to evaluate the effects of donanemab (LY3002813) versus placebo in Chinese participants who are at risk for decline of memory, language and physical ability to perform activities of daily living from Alzheimer's disease (AD).\n\nThe study drug will be administered intravenously (IV) (into a vein in the arm).\n\nThe study will last up to approximately 156 weeks, excluding screening.",[28],"2026-06-25",{"date":222,"type":33},{"date":243,"type":33},"2026-04-30",{"date":245,"type":22},"2030-04",{"name":247,"class":40},"Eli Lilly and Company",30,{"id":250,"slug":4,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":50,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":109,"conditions":253,"keywords":254,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":257,"leadSponsor":258,"locationsCount":74},"100410825",{"count":107,"type":22},[54],[89,28],[112,113,114],{"date":137,"type":33},{"date":117,"type":33},{"date":119,"type":22},{"name":259,"class":73},"Washington University School of Medicine",{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":267,"phases":4,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":74},"100338488","national-bank-alzheimer-100338488","NCT03687112","National Bank Alzheimer","BNA","Inclusion Criteria:\n\n* patients consulting in French Memory Centres\n\nExclusion Criteria:\n\n\\-","OBSERVATIONAL","The Alzheimer's disease (MY) is a major problem of public health. The French National Database Alzheimer ( BNA) registers(records) all the medical acts made by units of memory(report) and of independent specialists in France.\n\nIn 2008, the national Plan Alzheimer 2008 - 2012 had for objective to strengthen the search(research) on the Alzheimer's disease (MY) and for related disorders(confusions), to promote an early diagnosis and to improve at the same time the management of the patients and to support careers(quarries). A specific part(party) of this plan gave rise to the creation of the French national database Alzheimer ( BNA) to supply epidemiological data as well as indicators of activity. Since 2009 The information collected(taken in) in the BNA consists of a set(group) limited by data (CIMA of information minimum Corpus Alzheimer) concerning the demographic, clinical and diagnostic data defined by national consensus. The number of variables is limited to facilitate and to improve the participation in this national database. The participants are the Centers Report (CM)((LECTURE)) and Center Memory(Report) of Resources and Search(Research) (CMRR) and independent specialists. In 2015 more than 500 Centers send CIMA to the BNA.\n\nThe plan Disease Neurodegenerative 2014 - 2019 wishes to pursue and to amplify the BNA.",[28],{"date":188,"type":33},{"date":272,"type":33},"2009-01-01",{"date":274,"type":22},"2027-06-25",{"name":276,"class":73},"Centre Hospitalier Universitaire de Nice",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":299},"100640230","phase-3-a-study-of-donanemab-ly3002813-in-participants-who-completed-study-aacm-trailblazer-alz-3-ext-100640230","NCT07602582","A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).","An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM","Inclusion Criteria:\n\n* Have completed study AACM Addendum 7.\n* Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.\n* Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth.\n* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study.\n* Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants\u002Fcardiac pacemaker.\n* Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution.\n* Contraindication to florbetapir F 18 PET.\n* Have had history of amyloid-targeting therapy treatment outside donanemab trials.\n* Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study.",{"count":285,"type":22},550,[25],"The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.",[28,62,289],"Plaque, Amyloid",[291],"Donanemab","2026-06-24",{"date":222,"type":33},{"date":295,"type":33},"2026-05-22",{"date":297,"type":22},"2029-09",{"name":247,"class":40},58,{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":234,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":312,"conditions":313,"keywords":315,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":330},"100605160","phase-1-av-1980r-tau-vaccine-in-preclinical-alzheimers-disease-taurus-1980-100605160","NCT07158905","AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)","A Phase I, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of AV-1980R in Participants With Preclinical Alzheimer's Disease","TAURUS-1980","Inclusion Criteria:\n\nMale or post-menopausal\u002Fsurgically sterile female, 65-80 years of age.\n\nCognitively unimpaired with preclinical Alzheimer's disease:\n\nCDR global score = 0. MMSE ≥ 26. WMS-R LM II ≥ 6. Amyloid Probability Score 2 (APS2) \\> 54 (PrecivityAD2™). Adequate vision\u002Fhearing to comply with study procedures. Stable concomitant medications if applicable. Signed informed consent.\n\nExclusion Criteria:\n\nMRI abnormalities: \\>1 large lacunar infarct, territorial infarct, \\>5 microbleeds, ARIA-E, or other significant pathology.\n\nContraindications to MRI (e.g., pacemaker, metallic implants, severe claustrophobia).\n\nSerious illness or hospitalization within 4 weeks prior to enrollment. Clinically significant cardiovascular, endocrine, hematologic, autoimmune, or neurological disease.\n\nInsulin-dependent diabetes, significant arrhythmias, or seizure disorder. Positive C-SSRS (score ≥ 3). Prior tau or amyloid-beta immunotherapy within 1 year. Immunosuppressive or anticoagulant use that could interfere with study safety. Clinically significant lab abnormalities or positive HIV, HBV, or HCV screening.",{"count":309,"type":22},48,[311],"PHASE1","This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose-escalating trial to evaluate the safety, tolerability, and immune response of AV-1980R, an investigational vaccine targeting tau protein, in participants with preclinical Alzheimer's disease. Up to 48 cognitively unimpaired adults aged 65-80 with biomarker evidence of early Alzheimer's disease will be enrolled into three ascending dose cohorts. The study is designed as a secondary prevention trial to test whether therapeutic immunization at the preclinical stage is safe, induces an immune response, and, exploratorily, may favorably affect biomarkers associated with disease progression.",[28,314],"Preclinical Alzheimer's Disease",[316,317,318,314,319,320,321,322],"Tau protein","Immunotherapy","Vaccine","Alzheimer's Disease","secondary prevention","Neurodegeneration","Preventive Alzheimer's",{"date":222,"type":33},{"date":325,"type":33},"2026-06-23",{"date":327,"type":22},"2029-10-15",{"name":329,"class":73},"Institute for Molecular Medicine",3,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":15,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":26,"conditions":340,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":347},"100593846","phase-3-a-phase-3-study-to-evaluate-the-safety-and-efficacy-of-karxt--karx-ec-for-the-treatment-of-agitation-associated-with-alzheimers-disease-adagio-2-100593846","NCT07011745","A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)","Inclusion Criteria\n\n\\- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology:\n\ni) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42\u002F40 ratio in CSF, pTau181\u002FAβ42 ratio in CSF or pTau217\u002FAβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.\n\nii) If no historical evidence available:\n\nA. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.\n\nB. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:\n\n* Amyloid PET.\n* Aβ42\u002F40 ratio or pTau181\u002FAβ42 ratio in CSF using an HA-authorized diagnostic assay.\n\n  * Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1).\n  * Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to:\n\n    i) Attend all visits and report on participant's status.\n\nii) Oversee participant compliance with medication and study procedures.\n\niii) Participate in the study assessments and provide informed consent to participate in the study.\n\n* History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).\n* AD participants are required to have NPI\u002FNPI-NH Agitation\u002FAggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).\n* CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 2).\n* At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 2; CMAI-IPA Physical\u002FVerbal Aggression Positivity):\n\n  i) 1 or more aggressive behaviors occurring at least several times per week.\n\nii) 2 or more aggressive behaviors occurring at least once or twice per week.\n\niii) 3 or more aggressive behaviors occurring less than once per week.\n\nExclusion Criteria\n\n\\- Medical Conditions.\n\ni) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.\n\nii) History of bipolar disorder, schizophrenia, or schizoaffective disorder.\n\niii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.\n\niv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and\u002For C-SSR.\n\n\\- Prior\u002FConcomitant Therapy.\n\ni) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).\n\nA. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.\n\nB. Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).\n\n\\- Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":338,"type":22},352,[25],[28],{"date":240,"type":33},{"date":343,"type":33},"2025-07-16",{"date":345,"type":22},"2028-11-13",{"name":39,"class":40},145,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":17,"minAge":128,"maxAge":204,"enrollmentInfo":355,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":359,"conditions":360,"keywords":362,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":74},"100510283","phase-4-daridorexant-to-treat-insomnia-in-patients-with-mild-cognitive-impairment-and-mild-to-moderate-alzheimer-disease-100510283","NCT05924425","Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease","DARIDOR-ALZ","Inclusion criteria :\n\n* Age \\[60-85\\] years old\n* Outpatients\n* Pre-screening:\n\n  * Complaints of dissatisfaction with sleep quantity or quality, despite adequate opportunity for sleep, at least 3 nights per week and for at least 3 months, and\n  * Total sleep time causes clinically significant distress or impairment in daytime functioning, and\n  * Total sleep time estimated by interview was below 6 hours, on at least 3 nights per week and for at least 1 month before screening\n* Baseline PSG (at randomization) assessed TST \\\u003C 6 hours and WASO \\> 1 hour\n* Diagnosis of MCI and AD patients at an early stage according to the NIA diagnosis criteria (core clinical criteria for MCI, positive CSF Aβ42 and\u002For positive plasma biomarker, and neuronal injury (hippocampal and\u002For temporal atrophy by MRI))\n* MMSE from 12 to 26\n* Clinical Dementia Rating CDR from 0.5 to 2\n* Use of CNS-active medications is permitted provided the dose has been stable for at least 3 months, including: anticholinesterase drugs (rivastigmine, donepezil, galantamine) or memantine, antidepressants SSRI (e.g. fluoxetine, sertraline, paroxetine…), SNRI (e.g. venlafaxine, duloxetine), neuroleptics (e.g. clozapine, olanzapine, aripiprazole...) or drug for pain level 2 (codeine, tramadol).\n* For a male subject who is not sterilized and is sexually active with a female partner of childbearing potential, no contraceptive methods are needed\n\nNon inclusion criteria :\n\n* Patients significantly dependent on caregivers\n* Institutionalized patients\n* Analphabetism or subjects unable to read or\u002Fand write\n* Patients unable to perform the neuropsychological tests\n* Patients unable to complete the study instruments (sleep diary)\n* Planned longer stay outside the region that prevents compliance with the visit schedule\n* Patients who cannot be followed up for at least 2 months\n* History of narcolepsy and\u002For cataplexy\n* History of drug or alcohol abuse or addiction\n* History of diagnosed and characterized psychiatric disorders (DSM-5), cured or stabilized (with or without the same treatment for at least 3 months) and excluding any current characterized psychiatric disorder (DSM-5), the diagnosis of which is established by a psychiatrist trained in geriatric psychiatry\n* Moderate and severe liver failure\n* PSG baseline evidence of significant\u002Fsevere sleep-related breathing disorder (defined as \\>30 apnea\u002Fhypopnea episodes per hour)\n* Treatments interfering with sleep-wake patterns\n* Use of hypnotics (benzodiazepines, zolpidem, zopiclone) or drug for pain level 3 (morphine and derivatives)\n* Hypersensitivity to the active substance or to any of the excipients listed in the Summary of Product Characteristics (SmPC)\n* Forbidden and restricted concomitant medications:\n\n  * Concomitant CNS-depressant medicinal products\n  * CYP3A4 inhibitors\n  * CYP3A4 inducers\n* Participation in another clinical trial or administration of an investigational product\n* Protected population according to articles of the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship\u002Fcuratorship).\n* Subjects not covered by public health insurance\n* Failure to obtain written informed consent after a reflection period",{"count":356,"type":22},62,[358],"PHASE4","DARIDOR-ALZ is a phase IV clinical trial designed to evaluate both the efficacy and safety of daridorexant, a selective dual orexin receptor antagonist that blocks the actions of the orexin neuropeptides at both orexin-1 and orexin-2 receptors, in selected populations of MCI and mild-to-moderate AD patients with insomnia complaints.",[28,361,89],"Insomnia Disorder",[363,364,365,366,89,114],"Orexin","Daridorexant","Cognition","Alzheimer",{"date":240,"type":33},{"date":369,"type":33},"2024-03-13",{"date":371,"type":22},"2028-03-13",{"name":373,"class":73},"University Hospital, Montpellier",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":382,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":387,"conditions":388,"keywords":413,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":330},"100270060","neurologic-stem-cell-treatment-study-100270060","NCT02795052","Neurologic Stem Cell Treatment Study","Neurologic Bone Marrow Derived Stem Cell Treatment Study","NEST","Inclusion Criteria:\n\n1. Have documented functional damage to the central or peripheral nervous system unlikely to improve with present standard of care.\n2. Be at least 6 months post-onset of the disease.\n3. If under current medical therapy (pharmacologic or surgical treatment) for the condition be considered stable on that treatment and unlikely to have reversal of the associated neurologic functional damage as a result of the ongoing pharmacologic or surgical treatment.\n4. In the estimation of Dr. Weiss and the neurologists have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.\n5. Be over the age of 18 and capable of providing informed consent.\n6. Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.\n\nExclusion Criteria:\n\n1. All patients must be capable of an adequate neurologic examination and evaluation to document the pathology. This will include the ability to cooperate with the exam.\n2. Patients must be capable and willing to undergo follow up neurologic exams with the sub-investigators or their own neurologists as outlined in the protocol.\n3. Patients must be capable of providing informed consent.\n4. In the estimation of Dr. Weiss the BMSC collection and treatment will not present a significant risk of harm to the patient's general health or to their neurologic function. .\n5. Patients who are not medically stable or who may be at significant risk to their health undergoing the procedure will not be eligible.\n6. Women of childbearing age must not be pregnant at the time of treatment and should refrain from becoming pregnant for 3 months post treatment.","18 Years",{"count":384,"type":22},500,[386],"NA","This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1\u002F3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http:\u002F\u002Fmdstemcells.com\u002Fnest\u002F",[389,390,391,392,393,394,395,396,397,398,399,400,401,402,403,404,405,406,407,408,28,62,409,410,411,412],"Neurologic Disorders","Nervous System Diseases","Neurodegenerative Diseases","Neurological Disorders","Stroke","Traumatic Brain Injury","Cadasil","Chronic Traumatic Encephalopathy","Cerebral Infarction","Cerebral Ischemia","Cerebral Stroke","Cerebral Hemorrhage","Parkinson","Multi-System Degeneration","MSA - Multiple System Atrophy","Progressive Supranuclear Palsy","ALS","Amyotrophic Lateral Sclerosis","Neuropathy","Diabetic Neuropathies","Frontotemporal Dementia","Lewy Body Disease","Cognitive Impairment","Lewy Body Variant of Alzheimer Disease",[414,415,393,394,416,417,407,418,398,411,62,321],"Neurologic Disease","Cerebral Vascular Accident","Multiple Sclerosis","Parkinsons Disease","Diabetic Neuropathy",{"date":222,"type":33},{"date":421,"type":33},"2016-06",{"date":423,"type":22},"2028-07-31",{"name":425,"class":40},"MD Stem Cells",{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":17,"minAge":433,"maxAge":434,"enrollmentInfo":435,"targetDuration":4,"studyType":23,"phases":436,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":74},"100644642","far-infrared-therapy-for-the-effect-of-alzheimer-disease-dementia-100644642","NCT07672171","Far-Infrared Therapy for the Effect of Alzheimer Disease Dementia","To Explore the Effect of Far Infrared Therapy on Cognitive Function of Patients With Dementia","Inclusion Criteria:\n\n1. Diagnosed with Alzheimer's disease dementia.\n2. Mini-Mental State Examination (MMSE) score between 18 and 24 (inclusive).\n3. Currently prescribed and maintained on a stable regimen of anti-dementia medication.\n4. No sensory deficits or impairment regarding skin temperature perception.\n5. Patient or a Legally Authorized Representative (LAR) must be willing and capable of providing written informed consent prior to enrollment.\n\nExclusion Criteria:\n\n1. Non-Alzheimer's disease dementia (e.g., vascular dementia, Lewy body dementia, frontotemporal dementia).\n2. Known hypersensitivity to heat or light, including the current use of photosensitizing medications.\n3. Diminished thermal or heat sensitivity, such as from the concurrent use of analgesics, sedatives, or consumption of alcoholic beverages.\n4. Acute injury or acute localized inflammation, including active inflammation, infection, or ulcerated wounds.\n5. Concomitant acute venous thrombosis, varicose veins, severe peripheral arterial occlusive disease (Stage III or IV), lymphatic disease, acute rheumatoid arthritis, acute gout, or active fever.\n6. Presence of mottled erythema or other abnormal dermatological conditions on the scalp or neck.\n7. Localized skin lesions, damage, or open wounds at the device contact sites.\n8. Concurrent participation in any other clinical trial.\n9. Any other underlying pathological conditions or clinical statuses that, based on medical consensus, would preclude safe participation in the study.\n10. Failure or refusal to provide signed informed consent.\n11. Inability or unwillingness to comply with the trial protocols, schedules, or required follow-up evaluations.\n12. History or presence of hemorrhagic disorders or bleeding-related diseases.","61 Years","92 Years",{"count":130,"type":22},[386],"Alzheimer's disease (AD), the most common cause of dementia, is a progressive neurodegenerative disorder characterized by cognitive decline, including impaired learning ability, memory loss, and behavioral disturbances.\n\nAccording to surveys conducted by the Ministry of Health and Welfare in Taiwan, the prevalence of dementia among individuals aged 65 years and older was estimated at 7.86% in 2018, affecting more than 280,000 individuals, and is projected to approach 900,000 by 2065, resulting in substantial medical, social, and economic burdens. Current pharmacological treatments provide only limited symptomatic benefits and may be associated with adverse effects. Therefore, safe and effective non-pharmacological interventions that may support cognitive function and reduce caregiver burden are urgently needed.\n\nExperimental studies suggest that far-infrared (FIR) irradiation may enhance mitochondrial oxidative phosphorylation, increase ATP production, and promote microglial amyloid-β clearance, which may help delay the progression of Alzheimer's disease.\n\nThis trial aims to investigate the safety and effects of far-infrared (FIR) therapy on cognitive function in patients with Alzheimer's disease.\n\nThe findings may support the clinical application of FIR therapy as a non-pharmacological intervention to improve cognitive function and quality of life, reduce medication burden and treatment-related side effects, lessen caregiver burden, delay institutionalization, and reduce the social and economic burden associated with Alzheimer's disease.",[62,28],[440,62,160],"Far-infrared therapy",{"date":222,"type":33},{"date":443,"type":33},"2022-10-15",{"date":445,"type":22},"2029-10-31",{"name":447,"class":73},"Juin-Hong Cherng",{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":17,"minAge":382,"maxAge":456,"enrollmentInfo":457,"targetDuration":4,"studyType":267,"phases":4,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":330},"100616707","deep-learning-on-amyloid-positons-emission-tomography-100616707","NCT07309107","Deep Learning on Amyloid Positons Emission Tomography","Impact of Deep Learning-Based Noise Reduction Algorithm on Visual Analysis and Centiloid Quantification in Reduced-Dose and, or Time Acquisition Amyloid PET Imaging","DEEPAMY","Inclusion Criteria:\n\n* Patients with objective cognitive impairment,\n* Referred to our department for a cerebral \\[¹⁸F\\]flutemetamol positron emission tomography scan between January 1, 2023 and July 1, 2025,\n\nExclusion Criteria:\n\n* Patient have objected to the use of their data.","99 Years",{"count":130,"type":22},"Reducing injected dose and\u002For acquisition time in amyloid PET imaging would improve comfort, radiation safety and cost-effectiveness in diagnosis and follow-up of patients. This study evaluates the impact of a deep learning-based noise reduction algorithm on visual analysis and Centiloid quantification when simulating reduced injected doses of \\[18F\\]flutemetamol.",[28],{"date":240,"type":33},{"date":462,"type":33},"2026-05-06",{"date":464,"type":22},"2027-01-30",{"name":466,"class":73},"Central Hospital, Nancy, France",{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":234,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":476,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":490},"100581208","phase-2-study-of-lhp588-in-subjects-with-p-gingivalis-positive-alzheimers-disease-100581208","NCT06847321","Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease","A Randomized, Double-Blind, Placebo-Controlled Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease","Inclusion Criteria:\n\n* AD according to the National Institute on Aging-Alzheimer's Association criteria.\n* MMSE scores corresponding to mild and moderate AD.\n* Saliva rinse sample positive for P. gingivalis.\n* Plasma pTau217 above cutoff.\n* Subject and caregiver have provided full written informed consent.\n* Background symptomatic therapy with acetylcholinesterase inhibitors, and\u002For memantine, are allowed if the dose has been stable for 90 days and no changes are planned during the study.\n* Modified Hachinski score ≤4 at screening.\n\nExclusion Criteria:\n\n* History of cancer requiring systemic therapy in last 5 years.\n* Evidence of a clinically significant, unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurologic, or metabolic disease within 6 months prior to screening.\n* Unstable angina, uncompensated and\u002For symptomatic congestive heart failure (Grade 2 or higher on the New York Heart Association scale) or myocardial infarction within 6 months.\n* Acute or poorly controlled blood pressure \\>180 mmHg systolic or \\>100 mmHg diastolic at screening visit.\n* History or current evidence of major neurological or psychiatric illness such as schizophrenia, bipolar disorder, Parkinson's Disease, other.\n* Currently being treated with anti-amyloid beta antibodies or other disease-modifying treatments for dementia.\n* Other criteria in the Investigator's judgement that may interfere with the ability to participate in the study.",{"count":475,"type":22},300,[54],"This study is to test LHP588 in persons who have mild to moderate Alzheimer's disease (AD) who have shown progressive mental decline in the last year and who have P. gingivalis (Pg) infection. P. gingivalis infection has been linked to the development of dementia. LHP588 is designed to target the P. gingivalis bacterium, to potentially help to halt or slow down the progression of AD and its symptoms. A saliva test will be done to determine P. gingivalis infection. Tests for AD include standard questionnaires such as MMSE and a blood test for pTau217. Treatment will be blinded, meaning the participant and the doctor will not know if the participant is receiving LHP588 or placebo. The total time for participation in the study may be up to 64 weeks. This includes a screening period (to ensure the participant is suitable for the study and the study is suitable for the participant) of up to 12 weeks, a treatment period of up to 48 weeks, and a safety follow-up period of 4 weeks after the last dose of the study drug to check the participant's overall health. Treatment is a once-a-day capsule. Caregiver participation is required. The study requires the participant to visit the study center (with the caregiver) at least 20 times within 64 weeks (this does not include any unplanned visits that may be recommended by the study doctor). In addition, the study doctor or clinic staff will contact the participant via phone at least 1 time.",[28,479],"Alzheimer Disease Due to P. Gingivalis",[481,482,160],"placebo-controlled","p. gingivalis",{"date":292,"type":33},{"date":485,"type":33},"2025-02-17",{"date":487,"type":22},"2029-03-15",{"name":489,"class":40},"Lighthouse Pharmaceuticals, Inc.",39,{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":50,"sex":17,"minAge":382,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":23,"phases":499,"briefSummary":500,"conditions":501,"keywords":503,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":513,"locationsCount":74},"100519625","automated-assistive-non-contact-sleep-quality-monitor-for-individuals-with-alzheimers-disease-100519625","NCT06045988","Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease","Inclusion Criteria:\n\n* Diagnosis of Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementias (ADRD)\n* Residents of long-term care (LTC) facility study site location for a minimum of 30 days.\n* Willingness to consent to study or when a potential participant lacks decision making capacity (determined by LTC facility clinical provider) willingness of a Legally Authorized Representative (LAR) to consent to study participation on potential participant's behalf.\n\nExclusion Criteria:\n\n* Currently on hospice",{"count":498,"type":22},100,[386],"This study seeks to evaluate the utility and efficacy of the Non-Contact Sleep Quality Monitor System when used to monitor the sleep quality of individuals living in long-term care (LTC) with either Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementia (ADRD). This before-after comparison trial will be conducted in several LTC facilities to evaluate the effect access to System Sleep Quality Data has on documentation of sleep disorders or treatments and sleep quality change over time for AD\u002FADRD participants in the intervention group as compared to the control group.\n\nAll subjects will undergo sleep quality monitoring for 4-weeks. At the end of the first 2-weeks, research staff and LTC facility staff and medical providers will receive access to sleep monitoring data. We hypothesize that when real-time System Sleep Data is shared with LTC staff or healthcare providers, that sleep disturbances will be more readily detected, leading to timelier, better tailored treatment interventions for sleep disturbances, thereby improving sleep quality and decreasing daytime physical inactivity.",[28,62,502],"Sleep Disturbance",[504,505,506,62,507,508],"Sleep Assessment","Sleep Disorder","Technology","Long-Term Care","Sleep Monitoring",{"date":222,"type":33},{"date":511,"type":22},"2026-07",{"date":212,"type":22},{"name":514,"class":73},"Indiana University",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":523,"maxAge":204,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":74},"100621222","phase-1-allogeneic-adipose-tissue-derived-stem-cells-in-alzheimer-disease-100621222","NCT07367815","Allogeneic Adipose Tissue Derived-stem Cells in Alzheimer Disease","Allogeneic Intraveinous Injection of Adipose Tissue Derived-mesenchymal Stem Cells in Mild to Moderate Alzheimer Disease: a Phase I\u002FII Trial","A3D","Inclusion Criteria:\n\n* Patient between 50 and 85 years old\n* AD diagnosis according to NIA-AA 2011 criteria at a mild to moderate stage :\n\nMMSE score between 14 and 26 (include) positive AD amyloid biomarker\n\n* CDR (clinical dementia rating) score ≥ 1\n* Patient with no absolute contraindications for PET or MRI scans\n* Consent signed by the patient and study partner\n* presence of primary caregiver\n* Patient with social security coverage\n\nExclusion Criteria:\n\n* Brain disease (other than AD) that may cause dementia\n* Presence of concomitant pathologies not permitting participation in the study\n* Concurrent participation in other research that may influence the testing of the A3D study\n* Carrier of a pacemaker, valve prosthesis or other internal magnetic or electronic system, history of neurosurgery or aneurysm surgery, presence of metal fragments in the eyes, brain or marrow, claustrophobia\n* PET scan performed in the previous year (research context)\n* History of cancer diagnosed within the last 5 years\n* Presence of \\> 4 brain microbleeds, a single area of superficial siderosis, or evidence of previous macrohaemorrhage assessed by brain MRI scan\n* Regular use of corticosteroids or other steroidal anti-inflammatory drugs (e. g. prednisone)\n* Presence of an autoimmune disease (e. g. rheumatoid arthritis, systemic lupus erythematosus) with the exception of psoriasis\n* Pregnant or breastfeeding woman\n* Adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision For patients who will participate in the optional adipose puncture (only carried out in the Toulouse center): Antithrombotic treatment and xylocaine allergy are prohibited.","50 Years",{"count":525,"type":22},9,[311,54],"A3D is a phase I\u002FII clinical trial. The primary objective is to evaluate the safety of allogeneic adipose tissue derived-stem cells (AdMSC) administered by intravenous (IV) route in mild to moderate Alzheimer disease (AD) using a dose escalation protocol.",[28],[530,531,532,533,534],"Alzheimer disease,","phase I\u002FII,","safety,","mesenchymal stem cell,","adipose tissue","2026-06-18",{"date":325,"type":33},{"date":538,"type":33},"2026-05-07",{"date":540,"type":22},"2029-05-01",{"name":542,"class":73},"University Hospital, Toulouse",{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":50,"sex":17,"minAge":382,"maxAge":234,"enrollmentInfo":550,"targetDuration":4,"studyType":23,"phases":552,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":330},"100609958","phase-1-study-of-aro-mapt-sc-in-healthy-participants-and-participants-with-early-alzheimers-disease-100609958","NCT07221344","Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease","A Phase 1\u002F2a Placebo-Controlled Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer's Disease","Inclusion Criteria (All Participants):\n\n* Body mass index between 18.0 and 35.0 kilograms (kg)\u002Fsquare meter (m\\^2) at Screening\n* Not pregnant or breast-feeding\n* Able and willing to provide written informed consent prior to the performance of any study specific procedures\n* Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later; participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later\n\nInclusion Criteria (Alzheimer's Disease):\n\n* Adults aged 50 to 80 years of age with a clinical diagnosis of early AD and plasma, CSF, or imaging biomarkers consistent with the diagnosis\n* If participant is on AD medications, the doses must be stable for ≥weeks prior to Screening.\n\n  a. Participants with early AD are not required to be on AD medications.\n* Have a reliable and competent caregiver or trial partner who is ≥18 years of age, able and willing to accompany the participant to study visits involving informant-based assessments, to be available to site staff by telephone as needed, and in the opinion of the Investigator, be sufficiently familiar with the participant throughout the study in order to provide accurate and reliable information relevant to study outcome measures\n\nExclusion Criteria (All Participants):\n\n* Blood pressure outside of specified range in the protocol\n* Human immunodeficiency virus (HIV) infection (seropositive at Screening)\n* Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at Screening\n* Intellectual disability or significant behavioral neuropsychiatric manifestation\n* Clinically significant cardiac, liver, or renal disease\n* Any contraindications to lumbar puncture\n* Known allergy or possible allergy to either ARO-MAPT-SC or to its excipients\n\nNote: Additional inclusion\u002Fexclusion criteria may apply per protocol.",{"count":551,"type":22},112,[311,54],"Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of ARO-MAPT-SC compared to placebo in adult healthy volunteers and in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment due to AD and mild AD dementia.",[28,555],"Alzheimer Disease, Early Onset",{"date":325,"type":33},{"date":558,"type":33},"2025-11-18",{"date":560,"type":22},"2027-06",{"name":562,"class":40},"Arrowhead Pharmaceuticals",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":50,"sex":17,"minAge":382,"maxAge":18,"enrollmentInfo":569,"targetDuration":4,"studyType":23,"phases":570,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":74},"100457069","phase-2-cholinergic-integrity-in-down-syndrome-in-association-with-aging-alzheimers-disease-pathology-and-cognition-100457069","NCT05231798","Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition","Inclusion Criteria:\n\n1. Diagnosis of Down syndrome (DS), including mosaic DS or partial trisomy 21.\n2. Provision of signed and dated informed consent form and if needed, assent with signed consent by a legally authorized representative (LAR).\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Male or female, aged 18-55 inclusive.\n5. In good general health as evidenced by medical history with no diagnosis of dementia.\n6. Permitted CNS-active medications, stable in dose for at least 4 weeks or longer. If new medications have been started, the medical monitoring team will review on case-by-case basis to recommend timing of baseline cognitive testing\n7. Adequate visual and auditory acuity to allow neuropsychological testing\n8. For females who are not surgically sterile or post-menopausal by two years: negative pregnancy test 24 hours prior to PET scan.\n9. Mental Age of 4 years or greater (based upon the Kaufman Brief Intelligence Test, 2nd Edition)\n10. English must be first\u002Fnative language\n11. Reliable Study Partner (may be caregiver, sibling, parent) who can provide information about the subject's clinical symptoms and history\n\nExclusion Criteria:\n\n1. Any significant disease or unstable medical condition that could affect neuropsychological testing (i.e., unstable cardiac problems, chronic renal failure, chronic hepatic disease, severe pulmonary disease)\n2. Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant (Dental fillings do not present a risk for MRI)\n3. Participants unable to complete MRI and PET procedures\n4. IQ less than 40 (as assessed by Kaufman Brief Intelligence Test, Second Edition (KBIT-2).\n5. Pregnancy, breast-feeding\n6. History within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment\n7. Clinically significant abnormalities in B12 or TFTs that might interfere with the study. A low B12 is exclusionary unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant. A high TSH is exclusionary unless follow-up T3\u002FT4 levels indicate that it is not physiologically significant.\n8. Clinically significant abnormalities in screening laboratories\n9. For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation (e.g warfarin)\n10. Participants whom the Site PI deems to be otherwise ineligible\n11. Clinical diagnosis of dementia\n12. Concurrent participation in a clinical trial for an investigational product or concurrent participation in a longitudinal study with overlapping outcome measures\u002Fprocedures is prohibited",{"count":248,"type":22},[54],"Progressive age-related cognitive deficits occurring in both AD and DS have been connected to the degeneration of several neuronal populations, but mechanisms are not fully elucidated. The most consistent neuronal losses throughout the progression of AD are seen in cholinergic neurons where these losses negatively affect cognition, particularly in attention, learning, and memory formation. Evidence of reduced cholinergic integrity in DS is largely limited to animal models and post-mortem human data. The investigators propose to use molecular, functional, and structural biomarkers to assess the cholinergic integrity in adults with DS. The investigators anticipate using the data gathered in this pilot study to inform future study designs to determine AD risk stratification in DS by identifying individuals who show an accelerated decline in cholinergic integrity that correlates with cognitive and neurobehavioral changes. Also, our cholinergic biomarkers may identify whether individuals with DS are likely to respond to pro-cholinergic interventions, including the novel cholinergic modulators that are being developed to enhance cholinergic-sensitive cognitive functioning. The investigators anticipate using the data gathered here to inform future treatment studies in TRC-DS and beyond where novel cholinergic treatments may offer opportunities for early intervention in DS and be complementary to disease-modifying approaches such as anti-amyloid treatments.",[573,574,28],"Down Syndrome","Down Syndrome, Partial Trisomy 21","2026-06-17",{"date":577,"type":33},"2026-06-22",{"date":579,"type":33},"2021-08-19",{"date":581,"type":22},"2027-04-30",{"name":583,"class":73},"Vanderbilt University Medical Center",{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":382,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":23,"phases":594,"briefSummary":595,"conditions":596,"keywords":597,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":74},"100583752","mitochondrial-function-and-metabolomic-profile-in-alzheimers-disease-and-related-dementias-100583752","NCT06880406","Mitochondrial Function and Metabolomic Profile in Alzheimer's Disease and Related Dementias","Early Alterations of Peripheral Mitochondrial Function and Metabolomic Profile in Patients With Alzheimer's Disease and Related Dementias","AMPAlz","Inclusion Criteria:\n\n* Neurocognitive disorder with spontaneous complaint or reported for at least 6 months\n* Diagnostic process according to current Haute Autorité de Santé (HAS) recommendations.\n* cerebrospinal fluid biomarker dosage done within the study center and agreement to bio-collection of residual cerebrospinal fluid\n* Patient having agreed to sign the informed consent\n* Patient affiliated or beneficiary of a social security scheme\n\nFor alzheimer group : diagnosis of Alzheimer's disease according to NIA-AA 2024 criteria (presence of a pathogenic amyloid process in the cerebrospinal fluid)\n\nFor non alzheimer group : diagnosis of mild or major neurocognitive disorder according to Manuel diagnostique et statistique des troubles mentaux edition 5 (DSM-V) criteria, not linked to Alzheimer's disease (absence of pathogenic amyloid process in the cerebrospinal fluid)\n\nFor healthy volonteers:\n\n* Adult patients\n* No history of neurological or psychiatric disorders\n* No complaints of memory problems or cognitive impairment\n* Mini-Mental State Examination (MMSE) score ≥ 27\u002F30\n* Clinical Dementia Rating - Sum of Boxes (CDR-SOB) equal to 0\n* Patient affiliated with or covered by a social security scheme\n\nExclusion Criteria:\n\n\\- Vulnerable people",{"count":593,"type":22},250,[386],"This project aims to study on one hand the early mitochondrial alterations, common or specific, occurring in peripheral cells of patients with Alzheimer's disease or related dementia and, on the other hand, identify the metabolomic biomarkers that may be at the origin of mitochondrial disturbances associated with the disease. This will be the first study combining functional analyses of mitochondria and exploratory metabolomic assessments in the same cohort at early stages of the disease.",[28],[366,598,599],"mitochondrial function","metabolomic","2026-06-16",{"date":535,"type":33},{"date":603,"type":33},"2025-07-01",{"date":605,"type":22},"2029-04-01",{"name":276,"class":73}]