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NCT05557409 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
A Phase 3 study, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 408
- Enrollment target
NCT05557409: Completed Phase 3 study, sponsored by Axsome Therapeutics.
NCT05557409 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 408 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05557409, a Phase 3 study, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 408 participants
- Enrollment target
Study Summary
This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2022-09-06 |
| Est. Completion | 2024-12-21 |
| Phase | Phase 3 |
What the finished NCT05557409 record still lists
NCT05557409 is an interventional study that assigns participants to a tested intervention. The registered 408 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 (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05557409 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05557409 about?
NCT05557409 is a clinical study titled "A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation". This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.
What is the current status of trial NCT05557409?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 408 participants. The study started on 2022-09-06. Estimated completion is 2024-12-21.
What interventions are being tested in trial NCT05557409?
The interventions under investigation include: Placebo (DRUG), AXS-05 (DRUG).
Who is sponsoring clinical trial NCT05557409?
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 NCT05557409's enrollment target sits among peer trials
408 911th of 2000 higher than 1,088 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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