A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Diseas… (NCT04947553) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
United States456 participantsStarted 2021-06-17
Plain-language summary
This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.
Who can participate
Age range65 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participation in Study AXS-05-AD-302 or Study AXS-05-AD-304.
* 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:
* Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
* 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.