skip to Main Content

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


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.


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

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

– Unable to comply with study procedures.

– Medically inappropriate for study participation in the opinion of the investigator.


  • 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
Back To Top