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NCT04797715 · ClinicalTrials.gov registry record · Phase 3
Assessing Clinical Outcomes in Alzheimer's Disease Agitation
A Phase 3 study, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 178
- Enrollment target
NCT04797715: Completed Phase 3 study, sponsored by Axsome Therapeutics.
NCT04797715 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 178 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04797715, a Phase 3 study, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 178 participants
- Enrollment target
Study Summary
This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.
Interventions
- DRUG Placebo
- DRUG AXS-05
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2020-12-31 |
| Est. Completion | 2022-11-21 |
| Phase | Phase 3 |
What the finished NCT04797715 record still lists
NCT04797715 is an interventional study that assigns participants to a tested intervention. The registered 178 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 (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04797715 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04797715 about?
NCT04797715 is a clinical study titled "Assessing Clinical Outcomes in Alzheimer's Disease Agitation". This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.
What is the current status of trial NCT04797715?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 178 participants. The study started on 2020-12-31. Estimated completion is 2022-11-21.
What interventions are being tested in trial NCT04797715?
The interventions under investigation include: Placebo (DRUG), AXS-05 (DRUG).
Who is sponsoring clinical trial NCT04797715?
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 NCT04797715's enrollment target sits among peer trials
178 1437th of 2000 higher than 563 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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