At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 259 enrolled
Drug / intervention
Brexpiprazole +1 moredrug
Likely dose
Brexpiprazole 3 mgfrom 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 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
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jul 20, 2018·Updated Nov 14, 2023
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole for Alzheimer's Disease. Completed, enrolled 259 participants across 1 site.
Detailed Summary
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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesUnited States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartOct 2018
Primary CompletionSep 2022
TodayJul 2026
First PostedJul 20, 2018
Enrollment StartOct 11, 2018
Primary CompletionSep 19, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.0 years ago
Interventions
Brexpiprazoledrug
2 or 3 mg tablet
Brexpiprazoledrug
0.5 to 3 mg tablet