Assessing Clinical Outcomes in Alzheimer's Disease Agitation
Launched by AXSOME THERAPEUTICS, INC. · Mar 12, 2021
Trial Information
Current as of July 22, 2025
Completed
Keywords
ClinConnect Summary
Enrolled patients will first enter a 9-week, open-label stabilization period, during which they will be treated with AXS-05 and monitored for a treatment response. Patients who experience a treatment response during the stabilization period will then be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs.
Gender
ALL
Eligibility criteria
- 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.
- • Patient has symptoms of agitation that are not secondary to AD (e.g., pain, other psychiatric disorder or delirium due to a metabolic disorder, systemic infection, or substance-induced).
- • Unable to comply with study procedures.
- • Medically inappropriate for study participation in the opinion of the investigator.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders. With a commitment to addressing unmet medical needs, Axsome leverages its proprietary drug development platform to advance a diverse pipeline of product candidates targeting conditions such as depression, migraine, and insomnia. The company is dedicated to improving patient outcomes through rigorous clinical research and collaboration with healthcare professionals, aiming to transform the treatment landscape for patients suffering from debilitating neurological and psychiatric conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Antonio, Texas, United States
West Jordan, Utah, United States
Los Alamitos, California, United States
San Diego, California, United States
Hialeah, Florida, United States
Lake City, Florida, United States
Miami, Florida, United States
Ocoee, Florida, United States
Sunrise, Florida, United States
Tampa, Florida, United States
Toms River, New Jersey, United States
Lafayette, California, United States
Oceanside, California, United States
Everett, Washington, United States
Coral Springs, Florida, United States
Boise, Idaho, United States
Hickory, North Carolina, United States
Philadelphia, Pennsylvania, United States
Dayton, Ohio, United States
Santa Ana, California, United States
Naples, Florida, United States
Pensacola, Florida, United States
Cypress, Texas, United States
Kelowna, British Columbia, Canada
Sun City, Arizona, United States
Tucson, Arizona, United States
Chula Vista, California, United States
Imperial, California, United States
Los Angeles, California, United States
Temecula, California, United States
Kissimmee, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Saint Petersburg, Florida, United States
Trinity, Florida, United States
Columbus, Georgia, United States
Suwanee, Georgia, United States
Honolulu, Hawaii, United States
Wichita, Kansas, United States
Bangor, Maine, United States
Lowell, Massachusetts, United States
Flint, Michigan, United States
Chesterfield, Missouri, United States
Las Vegas, Nevada, United States
Brooklyn, New York, United States
East Syracuse, New York, United States
New Windsor, New York, United States
New York, New York, United States
Jenkintown, Pennsylvania, United States
Austin, Texas, United States
Houston, Texas, United States
Mckinney, Texas, United States
Mesquite, Texas, United States
Sugar Land, Texas, United States
Woodstock, Vermont, United States
Waukesha, Wisconsin, United States
Newmarket, Ontario, Canada
Augusta, Georgia, United States
Charlotte, North Carolina, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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