A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation

Conditions: Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation

Sex: All

Ages: 65 Years – 90 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 408

Sponsor: Axsome Therapeutics, Inc.

Summary

This trial was 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.

Eligibility 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 significant 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. * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05557409). StuddyBuddy aggregates publicly available trial information.