[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"agitation-associated-with-alzheimers-dementia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:agitation-associated-with-alzheimers-dementia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100566160","phase-2-a-study-to-assess-the-efficacy-and-safety-of-iti-1284-in-the-treatment-of-agitation-associated-with-alzheimers-dementia-100566160",false,"NCT06651567","A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia","A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study of the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Agitation Associated With Alzheimer's Dementia","Inclusion Criteria:\n\n* Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent to provide informed consent, with the patient's assent (if capable), consent may be provided by an appropriate person (eg, patient's Legally Authorized Representative \\[LAR\\]) before the initiation of any study-specific procedures in accordance with local regulations;\n* Meets clinical criteria for Alzheimer's disease based on 2011 National Institute of Aging-Alzheimer's Association (NIA-AA) dementia criteria and biomarker criteria and either:\n\n  * Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening; or\n  * Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;\n* Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition\n* Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation\u002FAggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline;\n* CGI-S score ≥ 4 at Screening and Baseline;\n* Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;\n\nExclusion Criteria:\n\n* Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment;\n* Has been diagnosed with one or more of the following psychiatric conditions:\n\n  * Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;\n  * Bipolar disorder;\n  * Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;\n* Has a significant risk for suicidal behavior during the course of their participation in the study, or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and\u002For as assessed by Columbia Suicide Severity Rating Scale (C-SSRS); or the patient has had 1 or more suicide attempts within the 2 years prior to Screening;\n* The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients.","ALL","55 Years",{"count":19,"type":20},320,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia",[26],"Agitation Associated With Alzheimer's Dementia","RECRUITING","2026-01-09",{"date":30,"type":31},"2026-01-12","ACTUAL",{"date":33,"type":31},"2024-10-22",{"date":35,"type":20},"2027-11",{"name":37,"class":38},"Intra-Cellular Therapies, Inc.","INDUSTRY",69,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100554197","electroacupuncture-for-the-treatment-of-agitated-symptoms-of-alzheimers-disease-100554197","NCT06495957","Electroacupuncture for the Treatment of Agitated Symptoms of Alzheimer's Disease","Evaluation of Therapeutic Effect and Brain Mechanism of Electroacupuncture in Treating Agitation Symptoms of Alzheimer's Disease","Inclusion Criteria:\n\n1. Meet the revised draft diagnostic criteria for Alzheimer's disease published by the Alzheimer's Association in 2023\n2. Meet the 2023 IPA definition of agitated symptoms of cognitive impairment\n3. Cohen Mansfield Agitation Inventory (CMAI)≥45 points\n4. Have been on stable anti-AD medication (cholinesterase inhibitors, etc.) for more than 1 month\n5. If taking antipsychotics, the medication regimen for agitation (antipsychotics) is stable for 1 month prior to randomization\n6. Subject and legal guardian and caregiver sign informed consent.\n\nExclusion Criteria:\n\n1. There are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal\n2. Received electroacupuncture treatment in the past 2 weeks\n3. At the time of the screening, participants are participating in other clinical trials or planned to participate in other clinical trials in the next 17 weeks.",{"count":48,"type":20},224,[50],"NA","The purpose of this study is to evaluate the efficacy of electroacupuncture in the treatment of agitation symptoms in patients with Alzheimer's disease (AD). Meanwhile the study aims to explore the brain central mechanism of electroacupuncture in the treatment of agitation symptoms in patients with AD by using resting state functional magnetic resonance technology.",[26,53],"Alzheimer's Dementia","NOT_YET_RECRUITING","2024-07-03",{"date":57,"type":31},"2024-07-11",{"date":59,"type":20},"2024-07-20",{"date":61,"type":20},"2027-10-31",{"name":63,"class":64},"Guang'anmen Hospital of China Academy of Chinese Medical Sciences","OTHER",7]