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
Public ClinicalTrials.gov record NCT06736509. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06736509
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 139 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 65 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 20, 2024
- Primary completion
- Feb 16, 2025
- Completion
- Apr 24, 2025
- Last update posted
- Jun 24, 2026
2024 – 2025
United States locations
- U.S. sites
- 21
- U.S. states
- 8
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Site | Peoria | Arizona | 85381 | — |
| Clinical Research Site | Walnut Creek | California | 94596 | — |
| Clinical Research Site | Bonita Springs | Florida | 34134 | — |
| Clinical Research Site | Brandon | Florida | 33511 | — |
| Clinical Research Site | Greenacres City | Florida | 33467 | — |
| Clinical Research Site | Hialeah | Florida | 33012 | — |
| Clinical Research Site | Miami | Florida | 33126 | — |
| Clinical Research Site | Miami | Florida | 33145 | — |
| Clinical Research Site | Miami | Florida | 33155 | — |
| Clinical Research Site | Miami | Florida | 33165 | — |
| Clinical Research Site | Miami | Florida | 33173 | — |
| Clinical Research Site | Miami Gardens | Florida | 33014 | — |
| Clinical Research Site | Miami Lakes | Florida | 33014 | — |
| Clinical Research Site | Pembroke Pines | Florida | 33025 | — |
| Clinical Research Site | Tampa | Florida | 33614 | — |
| Clinical Research Site | Tampa | Florida | 33634 | — |
| Clinical Research Site | Braintree | Massachusetts | 02184 | — |
| Clinical Research Site | Brooklyn | New York | 11229 | — |
| Clinical Research Site | Charlotte | North Carolina | 28211 | — |
| Clinical Research Site | Mesquite | Texas | 75149 | — |
| Clinical Research Site | Arlington | Virginia | 22205 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06736509, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 24, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06736509 live on ClinicalTrials.gov.