An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alz… (NCT06736509) | Clinical Trial Compass
TerminatedPhase 3
An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study
Stopped: Study AXS-05-AD-305 was terminated due to completion of overall program objectives.
United States139 participantsStarted 2024-11-21
Plain-language summary
The primary objective of this open-label extension trial is to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 and ACCORD-2.
Who can participate
Age range65 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Completed the treatment period in Study AXS-05-AD-304 or exited from Study AXS-05-AD-303 due to study completion.
* 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-304 and/or AXS-05-AD-303 which may pose a safety risk when taken concurrently with AXS-05.