A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

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 requiredstudy procedures, and oversee administration and compliance with the subject's studytreatment.

Exclusion Criteria:

• Caregiver is unwilling or unable, in the opinion of the investigator, to comply withstudy instructions.

• Subject is hospitalized in a mental health facility (e.g., psychiatric hospital orward), 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-304which may pose a safety risk when taken concurrently with AXS-05.