Alzheimer Disease Clinical Trial
— ADVANCEOfficial title:
A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type
| Verified date | August 2023 |
| Source | Axsome Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.
| Status | Completed |
| Enrollment | 366 |
| Est. completion date | April 17, 2020 |
| Est. primary completion date | April 17, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years to 90 Years |
| Eligibility | Key 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 signification 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 |
|---|---|---|---|
| Australia | Axsome study site | Caulfield | Melbourne, Victoria |
| United States | Axsome Study Site | Albany | New York |
| United States | Axsome Study Site | Apopka | Florida |
| United States | Axsome study site | Atlanta | Georgia |
| United States | Axsome study site | Avon | Indiana |
| United States | Axsome study site | Baton Rouge | Louisiana |
| United States | Axsome study site | Bellevue | Washington |
| United States | Axsome study site | Boca Raton | Florida |
| United States | Axsome study site | Boise | Idaho |
| United States | Axsome study site | Boynton Beach | Florida |
| United States | Axsome study site | Brooklyn | New York |
| United States | Axsome study site | Canoga Park | California |
| United States | Axsome Study Site | Charlotte | North Carolina |
| United States | Axsome study site | Charlotte | North Carolina |
| United States | Axsome Study Site | Charlottesville | Virginia |
| United States | Axsome study site | Chesterfield | Missouri |
| United States | Axsome study site | Cincinnati | Ohio |
| United States | Axsome Study Site | Coconut Creek | Florida |
| United States | Axsome Study Site | Colorado Springs | Colorado |
| United States | Axsome study site | Costa Mesa | California |
| United States | Axsome study site | Cromwell | Connecticut |
| United States | Axsome Study Site | Dayton | Ohio |
| United States | Axsome study site | Decatur | Georgia |
| United States | Axsome study site | DeSoto | Texas |
| United States | Axsome Study Site | Everett | Washington |
| United States | Axsome Study Site | Flossmoor | Illinois |
| United States | Axsome study site | Fresno | California |
| United States | Axsome Study Site | Gilbert | Arizona |
| United States | Axsome Study Site | Greenacres City | Florida |
| United States | Axsome study site | Hallandale Beach | Florida |
| United States | Axsome Study Site | Hattiesburg | Mississippi |
| United States | Axsome study site | Hialeah | Florida |
| United States | Axsome Study Site | Honolulu | Hawaii |
| United States | Axsome Study Site | Lake Charles | Louisiana |
| United States | Axsome Study Site | Lake City | Florida |
| United States | Axsome study site | Las Vegas | Nevada |
| United States | Axsome Study Site | Las Vegas | Nevada |
| United States | Axsome Study Site | Little Rock | Arkansas |
| United States | Axsome study site | Long Beach | California |
| United States | Axsome study site | Long Beach | California |
| United States | Axsome Study Site | Los Alamitos | California |
| United States | Axsome Study Site | McKinney | Texas |
| United States | Axsome study site | Miami | Florida |
| United States | Axsome study site | Miami | Florida |
| United States | Axsome study site | New London | Connecticut |
| United States | Axsome study site | New York | New York |
| United States | Axsome study site | New York | New York |
| United States | Axsome Study Site | Oklahoma City | Oklahoma |
| United States | Axsome study site | Orem | Utah |
| United States | Axsome Study Site | Orlando | Florida |
| United States | Axsome Study Site | Overland Park | Kansas |
| United States | Axsome study site | Pensacola | Florida |
| United States | Axsome Study Site | Phoenix | Arizona |
| United States | Axsome Study Site | Port Orange | Florida |
| United States | Axsome Study Site | Princeton | New Jersey |
| United States | Axsome Study Site | Richmond | Virginia |
| United States | Axsome study site | Riverside | California |
| United States | Axsome study site | Sacramento | California |
| United States | Axsome Study Site | Saint Louis | Missouri |
| United States | Axsome study site | Santa Ana | California |
| United States | Axsome Study Site | Santa Clarita | California |
| United States | Axsome study site | Scottsdale | Arizona |
| United States | Axsome study site | Scottsdale | Arizona |
| United States | Axsome study site | Shaker Heights | Ohio |
| United States | Axsome study site | Sherman Oaks | California |
| United States | Axsome study site | Simi Valley | California |
| United States | Axsome study site | Spokane | Washington |
| United States | Axsome study site | Spring Hill | Florida |
| United States | Axsome study site | Staten Island | New York |
| United States | Axsome study site | Tampa | Florida |
| United States | Axsome study site | Tampa | Florida |
| United States | Axsome study site | Temecula | California |
| United States | Axsome study site | Toms River | New Jersey |
| United States | Axsome Study Site | Topeka | Kansas |
| United States | Axsome Study Site | Tucson | Arizona |
| United States | Axsome study site | Ventura | California |
| United States | Axsome study site | Wichita Falls | Texas |
| United States | Axsome Study Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Axsome Therapeutics, Inc. |
United States, Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in CMAI Total Score | The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver-rated questionnaire that assesses the frequency of agitation-related and disruptive behaviors in subjects with dementia. The scale contains 29 behaviors or items organized into four subscales: physically aggressive, physically non-aggressive, verbally aggressive, and verbally non-aggressive. The CMAI is administered by interviewing the caregiver and asking him or her to rate the frequency with which the subject manifests each behavior using a seven-point scale: 1=never (better outcome), 7=several times an hour (worse outcome). The CMAI total score is the sum of the scores for all of the items in the CMAI. CMAI total scores range from a minimum of 29 (better outcome) to a maximum of 203 (worse outcome). | 5 weeks |
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