Clinical Research Directory
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A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
Sponsor: Axsome Therapeutics, Inc.
Summary
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.
Official 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
Key Details
Gender
All
Age Range
65 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
408
Start Date
2022-09-06
Completion Date
2024-12-21
Last Updated
2026-08-13
Healthy Volunteers
No
Interventions
AXS-05
AXS-05 tablets, taken twice daily
Placebo
Placebo tablets, taken twice daily
Locations (55)
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Peoria, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Canoga Park, California, United States
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Long Beach, California, United States
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Los Alamitos, California, United States
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Walnut Creek, California, United States
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West Covina, California, United States
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Bonita Springs, Florida, United States
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Brandon, Florida, United States
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Green Acres, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Gardens, Florida, United States
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Miami Lakes, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Augusta, Georgia, United States
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College Park, Georgia, United States
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Columbus, Georgia, United States
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Wichita, Kansas, United States
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Marrero, Louisiana, United States
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Braintree, Massachusetts, United States
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Flint, Michigan, United States
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Rochester Hills, Michigan, United States
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Troy, Michigan, United States
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Chesterfield, Missouri, United States
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Berlin, New Jersey, United States
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Toms River, New Jersey, United States
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Brooklyn, New York, United States
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New Windsor, New York, United States
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Staten Island, New York, United States
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Woodmere, New York, United States
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Charlotte, North Carolina, United States
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Hickory, North Carolina, United States
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Middleburg Heights, Ohio, United States
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Austin, Texas, United States
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Cypress, Texas, United States
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Mesquite, Texas, United States
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San Antonio, Texas, United States
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Sugarland, Texas, United States
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Rutland, Vermont, United States
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Arlington, Virginia, United States
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Bayamón, Puerto Rico, Puerto Rico
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San Juan, Puerto Rico, Puerto Rico