NCT05557409CompletedPhase 3
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
ADVANCE-2: Addressing Dementia Via Agitation-Centered Evaluation 2: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer's Disease Agitation
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
This trial was 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 408 (actual)
- First submitted
- 23 Sept 2022
- Start date
- 6 Sept 2022
- Primary completion date
- 21 Nov 2024
- Lead sponsor
- Axsome Therapeutics, Inc.
- Diseases
- Alzheimer disease
- NCT number
- NCT05557409
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 408
- From 6 Sept 2022 to the primary completion date, 21 Nov 2024
- 48 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient has dementia predominantly of non-Alzheimer's type.
Other
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Who the study is looking for
- Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
- Diagnosis of clinically significant agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.
Age in the registry: 65 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Site Coordinator of this site? Confirm its status | Bayamón | Puerto Rico | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Berlin | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Bonita Springs | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Braintree | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Brandon | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Canoga Park | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Chesterfield | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | College Park | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Cypress | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Green Acres | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Hickory | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Kissimmee | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Marrero | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Miami Gardens | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Middleburg Heights | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | New Windsor | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Pembroke Pines | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Rochester Hills | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Rutland | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Staten Island | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Sugarland | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Tempe | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Toms River | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | West Covina | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Woodmere | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.