A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer’s Type

Sponsor:

Brief Summary:

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.

Criteria

Inclusion Criteria:

– 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.

Exclusion Criteria:

– 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.

Locations

Clinical Research Site, Los Alamitos, California, United States, 90720
Clinical Research Site, Santa Ana, California, United States, 92705
Clinical Research Site, Temecula, California, United States, 92591