[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100331351":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":28,"responsibleParty":42,"collaborators":44,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":24,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":24,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":69,"whyStopped":24,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Otsuka Pharmaceutical Development & Commercialization, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prior Brexpiprazole","EXPERIMENTAL","Participants who received brexpiprazole in a previous double-blind phase 3 study (Trial 331-14-213 {NCT03548584}), received the same dose of brexpiprazole \\[2 or 3 milligrams (mg)\\], once daily (QD), orally, as they received during the previous study, for up to 12 weeks with dose adjustment.",[13],"Drug: Brexpiprazole",{"label":15,"type":10,"description":16,"interventionNames":17},"Prior Placebo","Participants who received placebo in a previous double-blind phase 3 study (Trial 331-14-213 {NCT03548584}), received brexpiprazole following a titration schedule, to gradually increase their dose from 0.5 mg QD, in the starting to 2 or 3 mg QD, orally, for up to 12 weeks with dose adjustment.",[13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Brexpiprazole","2 or 3 mg tablet",[9],null,{"type":20,"name":21,"description":26,"armGroupLabels":27,"otherNames":24},"0.5 to 3 mg tablet",[15],[29],{"facility":30,"status":24,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":24},"For additional information regarding sites, contact 844-687-8522","Miami","Florida","33155","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-80.19366,25.77427,{"lat":40,"lon":39},{"type":43,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[45],{"name":46,"class":6},"H. Lundbeck A\u002FS","100331351","phase-3-a-12-week-extension-trial-to-evaluate-the-safety-and-tolerability-of-brexpiprazole-in-the-treatment-of-subjects-with-agitation-associated-with-dementia-of-the-alzheimers-type-100331351",true,"NCT03594123","A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type","A 12-week, Multicenter, Active-treatment Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type","Inclusion Criteria:\n\n* Participants must have participated in the 331-14-213 study.\n* Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.\n\nExclusion Criteria:\n\n* Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.",false,"ALL","55 Years","91 Years",{"count":59,"type":60},259,"ACTUAL","INTERVENTIONAL",[63],"PHASE3","Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type (AAD).",[66],"Alzheimer's Disease",[68],"Agitation","COMPLETED","2023-10-27",{"date":72,"type":60},"2023-11-14",{"date":74,"type":60},"2018-10-11",{"date":76,"type":60},"2022-09-19",{"name":5,"class":6},1]