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NCT02442778 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 522
- Enrollment target
NCT02442778: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT02442778 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 522 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02442778, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 522 participants
- Enrollment target
Study Summary
Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) will be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.
Primary Outcome
The CMAI was used to assess the frequency of manifestations of agitated behaviors in elderly participants. It consists of 29 agitated items rated on a 7-point scale of frequency: 1, never; 2, less than once a week; 3, once or twice a week; 4, several times a week; 5, once or twice a day; 6, several times a day; 7, several times an hour. The CMAI total score ranges from 29 to 203. Higher scores indicate worsening of the condition. Negative change from baseline indicates improvement. Mixed Model R
Interventions
- DRUG Placebo
- DRUG AVP-786-28
- DRUG AVP-786-42.63
- DRUG AVP-786-18
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 522 participants |
| Start Date | 2015-11-11 |
| Est. Completion | 2019-09-09 |
| Phase | Phase 3 |
What the finished NCT02442778 record still lists
NCT02442778 is an interventional study that assigns participants to a tested intervention. The registered 522 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02442778 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02442778 about?
NCT02442778 is a clinical study titled "Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type". Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) will be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.
What is the current status of trial NCT02442778?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 522 participants. The study started on 2015-11-11. Estimated completion is 2019-09-09.
What interventions are being tested in trial NCT02442778?
The interventions under investigation include: Placebo (DRUG), AVP-786-28 (DRUG), AVP-786-42.63 (DRUG), AVP-786-18 (DRUG).
Who is sponsoring clinical trial NCT02442778?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02442778's enrollment target sits among peer trials
522 716th of 2000 higher than 1,284 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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