A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
NCT ID: NCT04947553
Last Updated: 2025-12-08
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
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COMPLETED
PHASE3
456 participants
INTERVENTIONAL
2021-06-17
2024-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AXS-05 (dextromethorphan-bupropion)
* Up to 52 weeks in the open-label segment;
* Up to 24 weeks in the randomized double-blind segment (if applicable)
AXS-05 (dextromethorphan-bupropion)
AXS-05 tablets, taken twice daily
Placebo
Up to 24 weeks in the randomized double-blind segment (if applicable)
Placebo
Placebo tablets, taken twice daily
Interventions
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AXS-05 (dextromethorphan-bupropion)
AXS-05 tablets, taken twice daily
Placebo
Placebo tablets, taken twice daily
Eligibility Criteria
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Inclusion Criteria
* Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment.
Exclusion Criteria
* Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone.
* Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being.
* Initiation of a new medication since enrolling in AXS-05-AD-302 or AXS-05-AD-304 which may pose a safety risk when taken concurrently with AXS-05.
65 Years
90 Years
ALL
No
Sponsors
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Axsome Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Site
Peoria, Arizona, United States
Clinical Research Site
Tempe, Arizona, United States
Clinical Research Site
Long Beach, California, United States
Clinical Research Site
Santa Ana, California, United States
Clinical Research Site
Temecula, California, United States
Clinical Research Site
Walnut Creek, California, United States
Clinical Research Site
Bonita Springs, Florida, United States
Clinical Research Site
Brandon, Florida, United States
Clinical Research Site
Coral Springs, Florida, United States
Clinical Research Site
Greenacres City, Florida, United States
Clinical Research Site
Hialeah, Florida, United States
Clinical Research Site
Hollywood, 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, 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
Orlando, Florida, United States
Clinical Research Site
Pembroke Pines, Florida, United States
Clinical Research Site
Tampa, Florida, United States
Clinical Research Site
Tampa, Florida, United States
Clinical Research Site
Trinity, Florida, United States
Clinical Research Site
Columbus, Georgia, United States
Clinical Research Site
Wichita, Kansas, United States
Clinical Research Site
Braintree, Massachusetts, United States
Clinical Research Site
Flint, Michigan, United States
Clinical Research Site
Rochester Hills, Michigan, United States
Clinical Research Site
Chesterfield, Missouri, United States
Clinical Research Site
Toms River, New Jersey, United States
Clinical Research Site
Brooklyn, New York, United States
Clinical Research Site
New Windsor, New York, United States
Clinical Research Site
Staten Island, New York, United States
Clinical Research Site
Charlotte, North Carolina, United States
Clinical Research Site
Hickory, North Carolina, United States
Clinical Research Site
Austin, Texas, United States
Clinical Research Site
Cypress, Texas, United States
Clinical Research Site
Mesquite, Texas, United States
Clinical Research Site
Sugar Land, Texas, United States
Clinical Research Site
Arlington, Virginia, United States
Clinical Research Site
Kelowna, British Columbia, Canada
Clinical Research Site
San Juan, , Puerto Rico
Countries
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Related Links
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Axsome Therapeutics Website
Other Identifiers
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AXS-05-AD-303
Identifier Type: -
Identifier Source: org_study_id
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