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NCT04947553 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
A Phase 3 study of Alzheimer Disease and Agitation,Psychomotor, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 456
- Enrollment target
- 20
- Study locations
NCT04947553: Completed Phase 3 study of Alzheimer Disease and Agitation,Psychomotor, sponsored by Axsome Therapeutics.
NCT04947553 is a Phase 3 study of Alzheimer Disease and Agitation,Psychomotor that has completed, run by Axsome Therapeutics. The registered enrollment target is 456 participants, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04947553, a Phase 3 study of Alzheimer Disease and Agitation,Psychomotor, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 456 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.
Primary Outcome
Incidence of treatment-emergent adverse events following dosing with AXS-05
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AXS-05 (dextromethorphan-bupropion)
Study Locations (20)
Florida
- Clinical Research Site - Bonita Springs
- Clinical Research Site - Brandon
- Clinical Research Site - Coral Springs
- Clinical Research Site - Greenacres City
- Clinical Research Site - Hialeah
- Clinical Research Site - Hollywood
- Clinical Research Site - Kissimmee
- Clinical Research Site - Lake City
- Clinical Research Site - Miami
- Clinical Research Site - Miami
- Clinical Research Site - Miami
- Clinical Research Site - Miami
- Clinical Research Site - Miami
- Clinical Research Site - Miami
California
- Clinical Research Site - Long Beach
- Clinical Research Site - Santa Ana
- Clinical Research Site - Temecula
- Clinical Research Site - Walnut Creek
Arizona
- Clinical Research Site - Peoria
- Clinical Research Site - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 456 participants |
| Start Date | 2021-06-17 |
| Est. Completion | 2024-12-21 |
| Phase | Phase 3 |
What the finished NCT04947553 record still lists
NCT04947553 is an interventional study that assigns participants to a tested intervention. The registered 456 participants enrollment target is mid-sized for trials with a published cap, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (83% lower).
The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04947553 names 20 study sites across 3 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04947553 about?
NCT04947553 is a clinical study titled "A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation". This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.
What is the current status of trial NCT04947553?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 456 participants. The study started on 2021-06-17. Estimated completion is 2024-12-21.
What conditions does trial NCT04947553 study?
This clinical trial studies the following conditions: Alzheimer Disease, Agitation,Psychomotor, Agitation in Patients With Dementia of the Alzheimer's Type.
What interventions are being tested in trial NCT04947553?
The interventions under investigation include: Placebo (DRUG), AXS-05 (dextromethorphan-bupropion) (DRUG).
Who is sponsoring clinical trial NCT04947553?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04947553 being conducted?
This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
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 NCT04947553's enrollment target sits among peer trials
456 56th of 306 higher than 250 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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