At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 164 enrolled
Drug / intervention
Brexpiprazoledrug
Likely dose
Brexpiprazole 1mgfrom 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 Multicenter, Uncontrolled, Open-label Trial to Evaluate the Safety of Extended Treatment With Brexpiprazole (OPC-34712) to Patients With Agitation Associated With Dementia of the Alzheimer's Type
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole for Agitation Associated With Dementia of the Alzheimer's Type. Completed, enrolled 164 participants across 1 site.
Detailed Summary
To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy of brexpiprazole.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartNov 2018
Primary CompletionDec 2021
Study CompletionJan 2022
TodayJul 2026
First PostedOct 30, 2018
Enrollment StartNov 9, 2018
Primary CompletionDec 2, 2021
Study CompletionJan 5, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.7 years ago
Interventions
Brexpiprazoledrug
Brexpiprazole 1mg or 2mg will be orally once daily for 14 weeks