Alzheimer Disease Clinical Trial
— ADVANCE-2Official title:
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
This trial is 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 | Recruiting |
| Enrollment | 350 |
| Est. completion date | June 2025 |
| Est. primary completion date | June 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years to 90 Years |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Patient has dementia predominantly of non-Alzheimer's type. - Unable to comply with study procedures. - Medically inappropriate for study participation in the opinion of the investigator. |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Clinical Research Site | Bayamon | |
| Puerto Rico | Clinical Research Site | San Juan | |
| United States | Clinical Research Site | Arlington | Virginia |
| United States | Clinical Research Site | Augusta | Georgia |
| United States | Clinical Research Site | Austin | Texas |
| United States | Clinical Research Site | Berlin | New Jersey |
| United States | Clinical Research Site | Braintree | Massachusetts |
| United States | Clinical Research Site | Brandon | Florida |
| United States | Clinical Research Site | Bronx | New York |
| United States | Clinical Research Site | Brooklyn | New York |
| United States | Clinical Research Site | Canoga Park | California |
| United States | Clinical Research Site | Charlotte | North Carolina |
| United States | Clinical Research Site | Chesterfield | Missouri |
| United States | Clinical Research Site | Cincinnati | Ohio |
| United States | Clinical Research Site | Columbus | Georgia |
| United States | Clinical Research Site | Cypress | Texas |
| United States | Clinical Research Site | Flint | Michigan |
| United States | Clinical Research Site | Greenacres City | Florida |
| United States | Clinical Research Site | Hialeah | Florida |
| United States | Clinical Research Site | Hickory | North Carolina |
| United States | Clinical Research Site | Hollywood | Florida |
| United States | Clinical Research Site | Kissimmee | Florida |
| United States | Clinical Research Site | Lafayette | California |
| United States | Clinical Research Site | Long Beach | California |
| United States | Clinical Research Site | Los Alamitos | California |
| United States | Clinical Research Site | Marrero | Louisiana |
| United States | Clinical Research Site | Mesquite | Texas |
| United States | Clinical Research Site | Methuen | Massachusetts |
| United States | Clinical Research Site | Miami | Florida |
| United States | Clinical Research Site | Miami | Florida |
| United States | Clinical Research Site | Miami | Florida |
| United States | Clinical Research Site | Miami | Florida |
| United States | Clinical Research Site | Miami | Florida |
| United States | Clinical Research Site | Miami | Florida |
| United States | Clinical Research Site | Miami | Florida |
| United States | Clinical Research Site | Miami Gardens | Florida |
| United States | Clinical Research Site | Miami Lakes | Florida |
| United States | Clinical Research Site | Middleburg Heights | Ohio |
| United States | Clinical Research Site | New Windsor | New York |
| United States | Clinical Research Site | Orlando | Florida |
| United States | Clinical Research Site | Pembroke Pines | Florida |
| United States | Clinical Research Site | Peoria | Arizona |
| United States | Clinical Research Site | Rochester Hills | Michigan |
| United States | Clinical Research Site | San Antonio | Texas |
| United States | Clinical Research Site | San Marcos | California |
| United States | Clinical Research Site | Staten Island | New York |
| United States | Clinical Research Site | Sugar Land | Texas |
| United States | Clinical Research Site | Tempe | Arizona |
| United States | Clinical Research Site | Toms River | New Jersey |
| United States | Clinical Research Site | Tucson | Arizona |
| United States | Clinical Research Site | West Covina | California |
| United States | Clinical Research Site | Wichita | Kansas |
| United States | Clinical Research Site | Woodmere | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Axsome Therapeutics, Inc. |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cohen-Mansfield Agitation Inventory (CMAI) | Up to 5 weeks |
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