Addressing Dementia Via Agitation-Centered Evaluation

Completed · Phase 2/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 is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.

Key facts

Study ID

NCT03226522

Run by

Axsome Therapeutics, Inc.

People needed

366

Starts

2017-07-13

Expected to finish

2020-04-17

Last updated by the study team

2023-09-13

Who can join

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

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

• Axsome Study Site — Phoenix, Arizona, United States
• Axsome study site — Scottsdale, Arizona, United States
• Axsome study site — Scottsdale, Arizona, United States
• Axsome Study Site — Tucson, Arizona, United States
• Axsome Study Site — Little Rock, Arkansas, United States
• Axsome study site — Canoga Park, California, United States
• Axsome study site — Costa Mesa, California, United States
• Axsome study site — Fresno, California, United States
• Axsome study site — Long Beach, California, United States
• Axsome study site — Long Beach, California, United States
• Axsome Study Site — Los Alamitos, California, United States
• Axsome study site — Riverside, California, United States
• Axsome study site — Sacramento, California, United States
• Axsome study site — Santa Ana, California, United States
• Axsome Study Site — Santa Clarita, California, United States
• Axsome study site — Sherman Oaks, California, United States
• Axsome study site — Simi Valley, California, United States
• Axsome study site — Temecula, California, United States
• Axsome study site — Ventura, California, United States
• Axsome Study Site — Colorado Springs, Colorado, United States
• Axsome study site — Cromwell, Connecticut, United States
• Axsome study site — New London, Connecticut, United States
• Axsome Study Site — Apopka, Florida, United States
• Axsome study site — Boca Raton, Florida, United States
• Axsome Study Site — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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