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NCT01862640 · ClinicalTrials.gov registry record · Phase 3
A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation
A Phase 3 study of Alzheimers Disease and Nervous System Diseases, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 433
- Enrollment target
- 20
- Study locations
NCT01862640: Completed Phase 3 study of Alzheimers Disease and Nervous System Diseases, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01862640 is a Phase 3 study of Alzheimers Disease and Nervous System Diseases that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 433 participants, below the 3,923-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01862640, a Phase 3 study of Alzheimers Disease and Nervous System Diseases, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 433 participants
- Enrollment target
- 20
- Study locations
Study Summary
To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.
Primary Outcome
To compare the efficacy of 2 fixed doses (1 mg/day and 2 mg/day) of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type, by the assessment of CMAI after 12 weeks of treatment. The CMAI assesses the frequency of agitated behaviors in elderly persons, such as hitting, cursing, and restlessness. It consists of 29 items all rated on a 1 to 7 scale with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total scor
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG Brexpiprazole, OPC-34712
Study Locations (20)
Florida
- - Coconut Creek
- - Hialeah
- - Hialeah
- - Hialeah
- - Lauderhill
- - Miami
- - Miami
- - Miami
- - Miami
- - Miami
- - Miami
California
- - Bellflower
- - Costa Mesa
- - Downey
- - Orange
- - Redlands
- - Yorba Linda
Alabama
- - Tuscaloosa
Arizona
- - Phoenix
Connecticut
- - Norwalk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 433 participants |
| Start Date | 2013-07-11 |
| Est. Completion | 2017-03-15 |
| Phase | Phase 3 |
What the finished NCT01862640 record still lists
NCT01862640 is an interventional study that assigns participants to a tested intervention. The registered 433 participants enrollment target is mid-sized for trials with a published cap, below the 3,923-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (89% lower).
The record links to 5 conditions, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT01862640 names 20 study sites across 5 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT01862640 about?
NCT01862640 is a clinical study titled "A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation". To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.
What is the current status of trial NCT01862640?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 433 participants. The study started on 2013-07-11. Estimated completion is 2017-03-15.
What conditions does trial NCT01862640 study?
This clinical trial studies the following conditions: Alzheimers Disease, Nervous System Diseases, Mental Disorder, Alzheimer's Type, Agitation Associated With.
What interventions are being tested in trial NCT01862640?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Brexpiprazole, OPC-34712 (DRUG).
Who is sponsoring clinical trial NCT01862640?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01862640 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01862640's enrollment target sits among peer trials
433 32nd of 147 higher than 116 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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