A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
Public ClinicalTrials.gov record NCT04947553. 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.
Official title
An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Dementia of the Alzheimer's Type
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.
Study identification
- NCT ID
- NCT04947553
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 456 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
- Jun 17, 2021 (Actual)
- Primary completion
- Dec 3, 2024 (Actual)
- Completion
- Dec 21, 2024 (Actual)
- Last update posted
- Dec 8, 2025
2021 – 2024
United States locations
- U.S. sites
- 45
- U.S. states
- 13
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Site | Peoria | Arizona | 83581 | — |
| Clinical Research Site | Tempe | Arizona | 85282 | — |
| Clinical Research Site | Long Beach | California | 90807 | — |
| Clinical Research Site | Santa Ana | California | 92705 | — |
| Clinical Research Site | Temecula | California | 92591 | — |
| Clinical Research Site | Walnut Creek | California | 94596 | — |
| Clinical Research Site | Bonita Springs | Florida | 34134 | — |
| Clinical Research Site | Brandon | Florida | 33511 | — |
| Clinical Research Site | Coral Springs | Florida | 33067 | — |
| Clinical Research Site | Greenacres City | Florida | 33467 | — |
| Clinical Research Site | Hialeah | Florida | 33012 | — |
| Clinical Research Site | Hollywood | Florida | 33024 | — |
| Clinical Research Site | Kissimmee | Florida | 34741 | — |
| Clinical Research Site | Lake City | Florida | 32055 | — |
| Clinical Research Site | Miami | Florida | 33126 | — |
| Clinical Research Site | Miami | Florida | 33135 | — |
| 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 | Florida | 33175 | — |
| Clinical Research Site | Miami Gardens | Florida | 33014 | — |
| Clinical Research Site | Miami Lakes | Florida | 33014 | — |
| Clinical Research Site | Orlando | Florida | 32807 | — |
| Clinical Research Site | Pembroke Pines | Florida | 33025 | — |
| Clinical Research Site | Tampa | Florida | 33614 | — |
| Clinical Research Site | Tampa | Florida | 33634 | — |
| Clinical Research Site | Trinity | Florida | 34655 | — |
| Clinical Research Site | Columbus | Georgia | 31909 | — |
| Clinical Research Site | Wichita | Kansas | 67214 | — |
| Clinical Research Site | Braintree | Massachusetts | 02184 | — |
| Clinical Research Site | Flint | Michigan | 48532 | — |
| Clinical Research Site | Rochester Hills | Michigan | 48307 | — |
| Clinical Research Site | Chesterfield | Missouri | 63005 | — |
| Clinical Research Site | Toms River | New Jersey | 08755 | — |
| Clinical Research Site | Brooklyn | New York | 11229 | — |
| Clinical Research Site | New Windsor | New York | 12553 | — |
| Clinical Research Site | Staten Island | New York | 10314 | — |
| Clinical Research Site | Charlotte | North Carolina | 28211 | — |
| Clinical Research Site | Hickory | North Carolina | 28601 | — |
| Clinical Research Site | Austin | Texas | 78737 | — |
| Clinical Research Site | Cypress | Texas | 77429 | — |
| Clinical Research Site | Mesquite | Texas | 75149 | — |
| Clinical Research Site | Sugar Land | Texas | 77478 | — |
| 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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04947553, 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 Dec 8, 2025 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04947553 live on ClinicalTrials.gov.