Trials / Completed
CompletedNCT03548584
A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 345 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 55 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose trial designed to assess the efficacy, safety, and tolerability of brexpiprazole compared with placebo. The trial consists of a 12-week double-blind treatment period with a 30 day follow-up. The trial population will include male and female participants between 55 and 90 years of age (inclusive) with a diagnosis of probable Alzheimer's disease, who are residing either in an institutionalized setting or in a non-institutionalized setting where the participant is not living alone. This trial will analyze data gathered from approximately 330 participants at multiple countries. Participants may also be eligible to enter an active treatment extension trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brexpiprazole | Oral tablets |
| OTHER | Placebo | Oral tablets |
Timeline
- Start date
- 2018-05-16
- Primary completion
- 2022-05-23
- Completion
- 2022-06-01
- First posted
- 2018-06-07
- Last updated
- 2023-09-18
- Results posted
- 2023-09-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03548584. Inclusion in this directory is not an endorsement.