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 early · Phase 3

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

In brief

The primary objective of this open-label extension trial was to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 or ACCORD-2.

Key facts

Study ID

NCT06736509

Run by

Axsome Therapeutics, Inc.

People needed

139

Starts

2024-11-21

Expected to finish

2025-04-25

Last updated by the study team

2026-06-25

Who can join

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

You may qualify if…

• 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.

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-304 and/or AXS-05-AD-303 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 — Walnut Creek, California, United States
• Clinical Research Site — Bonita Springs, Florida, United States
• Clinical Research Site — Brandon, Florida, United States
• Clinical Research Site — Greenacres City, Florida, United States
• Clinical Research Site — Hialeah, 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 — Pembroke Pines, Florida, United States
• Clinical Research Site — Tampa, Florida, United States
• Clinical Research Site — Tampa, Florida, United States
• Clinical Research Site — Braintree, Massachusetts, United States
• Clinical Research Site — Brooklyn, New York, United States
• Clinical Research Site — Charlotte, North Carolina, United States
• Clinical Research Site — Mesquite, Texas, United States
• Clinical Research Site — Arlington, Virginia, United States
• Clinical Research Site — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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