A Study to Assess the Efficacy and Safety 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

In brief

This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.

Key facts

Study ID

NCT05557409

Run by

Axsome Therapeutics, Inc.

People needed

408

Starts

2022-09-06

Expected to finish

2024-12-21

Last updated by the study team

2025-11-26

Who can join

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

You may qualify if…

• Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
• Diagnosis of clinically significant agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.

You may not qualify if…

• Patient has dementia predominantly of non-Alzheimer's type.
• Unable to comply with study procedures.
• Medically inappropriate for study participation in the opinion of the investigator.

Where it is running

• Clinical Research Site — Tempe, Arizona, United States
• Clinical Research Site — Tucson, Arizona, United States
• Clinical Research Site — Canoga Park, California, United States
• Clinical Research Site — Long Beach, California, United States
• Clinical Research Site — Los Alamitos, California, United States
• Clinical Research Site — Walnut Creek, California, United States
• Clinical Research Site — West Covina, 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 — Hollywood, Florida, United States
• Clinical Research Site — Kissimmee, 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
• Clinical Research Site — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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