CompletedPhase 2/3

Addressing Dementia Via Agitation-Centered Evaluation

United States366 participantsStarted 2017-07-13

Plain-language summary

This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients 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.

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

What they're measuring

Change in CMAI Total Score

Timeframe: 5 weeks

Trial details

NCT IDNCT03226522

SponsorAxsome Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-17

Results submitted2023-02-14

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