Open-Label Safety Study of AXS-05 in Subjects With Alzheimer's Disease Agitation

• Status: Enrolling by invitation
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with agitation associated with Alzheimer's disease (AD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axsome Therapeutics, Inc.
• Treatments: Bupropion; Dextromethorphan

Criteria

Inclusion Criteria:

• Participation in Study AXS-05-AD-302.

• 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 which may pose a safety risk when taken concurrently with AXS-05.