At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 410 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 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole and Placebo for Agitation Associated With Dementia of the Alzheimer's Type. Completed, enrolled 410 participants across 1 site.
Detailed Summary
To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the safety of brexpiprazole and identify the optimum dose.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartAug 2018
Primary CompletionApr 2023
Study CompletionMay 2023
TodayJul 2026
First PostedAug 8, 2018
Enrollment StartAug 20, 2018
Primary CompletionApr 21, 2023
Study CompletionMay 15, 2023
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 7.9 years ago
Interventions
Brexpiprazoledrug
Drug: 1 tablet /day Once daily for 10 weeks
Placebodrug
Placebo: 1 tablet /day Once daily for 10 weeks