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NCT03226522 · ClinicalTrials.gov registry record · Phase 2
Addressing Dementia Via Agitation-Centered Evaluation
A Phase 2 study, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 366
- Enrollment target
NCT03226522: Completed Phase 2 study, sponsored by Axsome Therapeutics.
NCT03226522 is a Phase 2 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 366 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (175% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03226522, a Phase 2 study, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 366 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.
Primary Outcome
The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver-rated questionnaire that assesses the frequency of agitation-related and disruptive behaviors in subjects with dementia. The scale contains 29 behaviors or items organized into four subscales: physically aggressive, physically non-aggressive, verbally aggressive, and verbally non-aggressive. The CMAI is administered by interviewing the caregiver and asking him or her to rate the frequency with which the subject manifests each
Interventions
- DRUG Placebo
- DRUG AXS-05
- DRUG Bupropion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2017-07-13 |
| Est. Completion | 2020-04-17 |
| Phase | Phase 2 |
What the finished NCT03226522 record still lists
NCT03226522 is an interventional study that assigns participants to a tested intervention. The registered 366 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (175% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03226522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03226522 about?
NCT03226522 is a clinical study titled "Addressing Dementia Via Agitation-Centered Evaluation". This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.
What is the current status of trial NCT03226522?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 366 participants. The study started on 2017-07-13. Estimated completion is 2020-04-17.
What interventions are being tested in trial NCT03226522?
The interventions under investigation include: Placebo (DRUG), AXS-05 (DRUG), Bupropion (DRUG).
Who is sponsoring clinical trial NCT03226522?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03226522's enrollment target sits among peer trials
366 121st of 2000 higher than 1,880 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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