Assessing Clinical Outcomes in Alzheimer's Disease Agitation
NCT ID: NCT04797715
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
178 participants
INTERVENTIONAL
2020-12-31
2022-11-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AXS-05
Up to 26 weeks in double-blind period
AXS-05
AXS-05 tablets, taken twice daily
Placebo
Up to 26 weeks in double-blind period
Placebo
Placebo tablets, taken twice daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AXS-05
AXS-05 tablets, taken twice daily
Placebo
Placebo tablets, taken twice daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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 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.
65 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Axsome Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Research Site
Sun City, Arizona, United States
Clinical Research Site
Tucson, Arizona, United States
Clinical Research Site
Chula Vista, California, United States
Clinical Research Site
Imperial, California, United States
Clinical Research Site
Lafayette, California, United States
Clinical Research Site
Los Alamitos, California, United States
Clinical Research Site
Los Angeles, California, United States
Clinical Research Site
Oceanside, California, United States
Clinical Research Site
San Diego, California, United States
Clinical Research Site
Santa Ana, California, United States
Clinical Research Site
Temecula, California, United States
Clinical Research Site
Coral Springs, Florida, United States
Clinical Research Site
Hialeah, Florida, United States
Clinical Research Site
Kissimmee, Florida, United States
Clinical Research Site
Lake City, 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 Lakes, Florida, United States
Clinical Research Site
Naples, Florida, United States
Clinical Research Site
Ocoee, Florida, United States
Clinical Research Site
Orlando, Florida, United States
Clinical Research Site
Orlando, Florida, United States
Clinical Research Site
Pembroke Pines, Florida, United States
Clinical Research Site
Pensacola, Florida, United States
Clinical Research Site
St. Petersburg, Florida, United States
Clinical Research Site
Sunrise, Florida, United States
Clinical Research Site
Tampa, Florida, United States
Clinical Research Site
Trinity, Florida, United States
Clinical Research Site
Augusta, Georgia, United States
Clinical Research Site
Columbus, Georgia, United States
Clinical Research Site
Suwanee, Georgia, United States
Clinical Research Site
Honolulu, Hawaii, United States
Clinical Research Site
Boise, Idaho, United States
Clinical Research Site
Wichita, Kansas, United States
Clinical Research Site
Bangor, Maine, United States
Clinical Research Site
Lowell, Massachusetts, United States
Clinical Research Site
Flint, Michigan, United States
Clinical Research Site
Chesterfield, Missouri, United States
Clinical Research Site
Las Vegas, Nevada, United States
Clinical Research Site
Toms River, New Jersey, United States
Clinical Research Site
Brooklyn, New York, United States
Clinical Research Site
East Syracuse, New York, United States
Clinical Research Site
New Windsor, New York, United States
Clinical Research Site
New York, New York, United States
Clinical Research Site
Charlotte, North Carolina, United States
Clinical Research Site
Hickory, North Carolina, United States
Clinical Research Site
Dayton, Ohio, United States
Clinical Research Site
Jenkintown, Pennsylvania, United States
Clinical Research Site
Philadelphia, Pennsylvania, United States
Clinical Research Site
Austin, Texas, United States
Clinical Research Site
Cypress, Texas, United States
Clinical Research Site
Houston, Texas, United States
Clinical Research Site
McKinney, Texas, United States
Clinical Research Site
Mesquite, Texas, United States
Clinical Research Site
San Antonio, Texas, United States
Clinical Research Site
Sugar Land, Texas, United States
Clinical Research Site
West Jordan, Utah, United States
Clinical Research Site
Woodstock, Vermont, United States
Clinical Research Site
Everett, Washington, United States
Clinical Research Site
Waukesha, Wisconsin, United States
Clinical Research Site
Kelowna, British Columbia, Canada
Clinical Research Site
Newmarket, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Axsome Therapeutics Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AXS-05-AD-302
Identifier Type: -
Identifier Source: org_study_id