CompletedPhase 3

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

United States178 participantsStarted 2020-12-31

Plain-language 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.

Who can participate

Age range65 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Time from randomization to relapse of agitation symptoms

Timeframe: up to 26 weeks

Trial details

NCT IDNCT04797715

SponsorAxsome Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-21

View on ClinicalTrials.gov More Agitation in Patients With Dementia of the Alzheimer's Type trials