Assessing Clinical Outcomes in 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 is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.

Key facts

Study ID

NCT04797715

Run by

Axsome Therapeutics, Inc.

People needed

178

Starts

2020-12-31

Expected to finish

2022-11-21

Last updated by the study team

2023-11-29

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 signification 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.
• Patient has symptoms of agitation that are not secondary to AD (e.g., pain, other psychiatric disorder or delirium due to a metabolic disorder, systemic infection, or substance-induced).
• Unable to comply with study procedures.
• Medically inappropriate for study participation in the opinion of the investigator.

Where it is running

• Clinical Research Site — Tucson, Arizona, United States
• Clinical Research Site — Chula Vista, California, United States
• Clinical Research Site — Imperial, California, United States
• Clinical Research Site — Lafayette, California, United States
• Clinical Research Site — Los Alamitos, California, United States
• Clinical Research Site — Los Angeles, California, United States
• Clinical Research Site — Oceanside, California, United States
• Clinical Research Site — San Diego, California, United States
• Clinical Research Site — Santa Ana, California, United States
• Clinical Research Site — Temecula, California, United States
• Clinical Research Site — Coral Springs, Florida, United States
• Clinical Research Site — Hialeah, 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 Lakes, Florida, United States
• Clinical Research Site — Naples, Florida, United States
• Clinical Research Site — Ocoee, Florida, United States
• Clinical Research Site — Orlando, Florida, United States
• Clinical Research Site — Orlando, Florida, United States
• Clinical Research Site — Pembroke Pines, Florida, United States
• Clinical Research Site — Pensacola, Florida, United States
• Clinical Research Site — Sun City, Arizona, United States

Full record on ClinicalTrials.gov

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