At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 345 enrolled
Drug / intervention
Brexpiprazole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jun 7, 2018·Updated Sep 18, 2023
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole and Placebo for Agitation Associated With Alzheimer's Dementia and Alzheimer Dementia. Completed, enrolled 345 participants across 1 site.
Detailed Summary
This study compares the efficacy of 2 doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
First PostedJun 2018
Primary CompletionMay 2022
Study CompletionJun 2022
TodayJul 2026
First PostedJun 7, 2018
Enrollment StartMay 16, 2018
Primary CompletionMay 23, 2022
Study CompletionJun 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 8.1 years ago
Interventions
Brexpiprazoledrug
Oral tablets
Placeboother
Oral tablets