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NCT06736509 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study
A Phase 3 study, sponsored by Axsome Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 139
- Enrollment target
NCT06736509: Clinical Trial Phase 3 study, sponsored by Axsome Therapeutics.
NCT06736509 is a Phase 3 study that was terminated before completion, run by Axsome Therapeutics. The registered enrollment target is 139 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06736509, a Phase 3 study, was terminated before completion, sponsored by Axsome Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 139 participants
- Enrollment target
Study Summary
The primary objective of this open-label extension trial was to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 or ACCORD-2.
Primary Outcome
Incidence of treatment-emergent adverse events following dosing with AXS-05
Interventions
- DRUG AXS-05 (dextromethorphan-bupropion)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2024-11-21 |
| Est. Completion | 2025-04-25 |
| Phase | Phase 3 |
Why NCT06736509 stopped before completion
NCT06736509 is an interventional study that assigns participants to a tested intervention. The registered 139 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 (82% lower).
The record links to 0 conditions, and to 1 intervention - of which AXS-05 (dextromethorphan-bupropion) is the first listed.
NCT06736509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06736509 about?
NCT06736509 is a clinical study titled "An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study". The primary objective of this open-label extension trial was to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 or ACCORD-2.
What is the current status of trial NCT06736509?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 139 participants. The study started on 2024-11-21. Estimated completion is 2025-04-25.
What interventions are being tested in trial NCT06736509?
The interventions under investigation include: AXS-05 (dextromethorphan-bupropion) (DRUG).
Who is sponsoring clinical trial NCT06736509?
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 NCT06736509's enrollment target sits among peer trials
139 1577th of 2000 higher than 424 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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