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NCT01922258 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
A Phase 3 study of Alzheimers Disease and Nervous System Diseases, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
- 20
- Study locations
NCT01922258: Completed Phase 3 study of Alzheimers Disease and Nervous System Diseases, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01922258 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 270 participants, below the 3,924-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01922258, 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
- 270 participants
- Enrollment target
- 20
- Study locations
Study Summary
To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type
Primary Outcome
The CMAI is widely used in clinical research for evaluation of agitation associated with Alzheimer's dementia, with reliability and validity in both institutionalized and noninstitutionalized participants. It consists of 29 items, all rated on a 1 to 7 scale (1=Never and 7=Several times in an hour), with 1 being the "best" rating and 7 being the "worst" rating. The total score is the sum of ratings for all 29 items. The possible total scores range from 29 to 203. The total score will be unevalua
Conditions Studied
Interventions
- DRUG Brexpiprazole, OPC-34712
Study Locations (20)
California
- - Imperial
- - Lakewood
- - Long Beach
- - Long Beach
- - Panorama City
- - Universal City
Florida
- - Bradenton
- - Miami
- - Miami
- - Miami
- - Orange City
Georgia
- - Atlanta
- - Smyrna
Massachusetts
- - Quincy
- - South Dartmouth
Colorado
- - Denver
Hawaii
- - Honolulu
Indiana
- - Indianapolis
Michigan
- - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-03 |
| Phase | Phase 3 |
What the finished NCT01922258 record still lists
NCT01922258 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, below the 3,924-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Alzheimers Disease appearing as the primary indexed condition, and to 1 intervention - of which Brexpiprazole, OPC-34712 is the first listed.
NCT01922258 names 20 study sites across 9 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01922258 about?
NCT01922258 is a clinical study titled "Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type". To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type
What is the current status of trial NCT01922258?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2013-09. Estimated completion is 2017-03.
What conditions does trial NCT01922258 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 NCT01922258?
The interventions under investigation include: Brexpiprazole, OPC-34712 (DRUG).
Who is sponsoring clinical trial NCT01922258?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01922258 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Hawaii. 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 NCT01922258's enrollment target sits among peer trials
270 46th of 147 higher than 102 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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