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

Completed · Phase 3 · Has a placebo group

Conditions studied: Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor

In brief

This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.

Key facts

Study ID

NCT04947553

Run by

Axsome Therapeutics, Inc.

People needed

456

Starts

2021-06-17

Expected to finish

2024-12-21

Last updated by the study team

2025-12-08

Who can join

Age: 65 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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