[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"agitation-associated-with-alzheimers-disease-dementia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:agitation-associated-with-alzheimers-disease-dementia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100614813","phase-2-safety-and-efficacy-of-exv-802-and-exv-801-in-the-treatment-of-agitation-in-alzheimers-disease-dementia-100614813",false,"NCT07284472","Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia","Phase 2\u002F3, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Participants With Alzheimer's Disease Dementia","SERENADA","Inclusion criteria:\n\n1. The participant is an adult male or female between the ages of 55 to 90 years inclusively, who can move around by themselves, with a walker or a wheelchair.\n2. A previously established diagnosis of AD dementia.\n3. The participant has clinically significant, moderate\u002Fsevere agitation at the time of screening and for at least 2 weeks prior to randomization\n4. The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.\n5. Caregiver who is able and willing to comply with all required study procedures and who is in contact with the participant at least on four individual days for at least two hours per day.\n\nExclusion criteria:\n\n1. The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia.\n2. The participant has symptoms of agitation that are not secondary to AD dementia\n3. The participant has a history of uncontrolled seizures or a history of epilepsy.\n4. The participant has a major medical illness or unstable medical condition","ALL","55 Years","90 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","The goal of this clinical trial is to evaluate the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.",[29],"Agitation Associated With Alzheimer's Disease Dementia","RECRUITING","2026-06-04",{"date":33,"type":34},"2026-06-05","ACTUAL",{"date":36,"type":34},"2026-02-02",{"date":38,"type":22},"2029-02",{"name":40,"class":41},"Exciva GmbH","INDUSTRY",49,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100577863","phase-2-a-study-of-ono-2020-in-patients-with-agitation-associated-with-alzheimers-disease-dementia-100577863","NCT06803823","A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia","A Phase 2a, Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia","Inclusion Criteria:\n\n* Diagnosis of probable AD according to the diagnostic criteria for AD dementia (NIA-AA 2011)\n* Mini-Mental State Examination (MMSE) score ≥ 5 to ≤ 22 at the start of the treatment period\n* Symptoms of agitation defined by the IPA from at least 14 days before the start of the screening period\n* Neuropsychiatric Inventory-Nursing Home version (NPI-NH) Agitation\u002FAggression domain (NPI-NH-A\u002FA) score ≥ 4 at the start of the treatment period.\n* Patients who can participate in the study under hospitalization from 21 days before the start of the treatment period to throughout the treatment period\n\nExclusion Criteria:\n\n* Diagnosis of dementia not due to AD or any other disorder with memory impairment, such as mixed dementia, vascular dementia, Lewy body dementia, dementia associated with Parkinson's disease, frontotemporal dementia, drug-induced dementia, dementia associated with human immunodeficiency virus (HIV) infection, traumatic brain injury, normal pressure hydrocephalus, or other non-AD dementia\n* Any MRI or CT scan of the brain performed after the onset of dementia with findings consistent with clinically relevant CNS disease other than AD, such as vascular changes (eg, cortical cerebral infarction, multiple cerebral infarctions), space-occupying lesions (eg, tumors), or any other major structural brain disease\n* Delirium within 30 days before the start of the screening period or a history of delirium\n* At risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) (answers \"yes\" to Question 4 or 5 of the suicidal ideation section of the C-SSRS) or any suicide attempt within 6 months before the start of the screening period, or at serious risk of suicide in the opinion of the investigator or subinvestigator\n* Prior or current treatment with anti-amyloid beta antibodies",{"count":51,"type":22},90,[25],"To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.",[29],"2026-05-10",{"date":57,"type":34},"2026-05-12",{"date":59,"type":34},"2025-05-01",{"date":61,"type":22},"2027-03-31",{"name":63,"class":41},"Ono Pharmaceutical Co., Ltd.",38]