Addressing Dementia Via Agitation-Centered Evaluation: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer's Disease Agitation

Last updated: July 23, 2024
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Alzheimer's Disease

Dementia

Treatment

N/A

Clinical Study ID

TX400019
AXS-05-AD-304
  • Ages 65-90
  • All Genders

Study Summary

"A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation (ADVANCE-2) "

Eligibility Criteria

Inclusion

<p>Inclusion Criteria:</p><ul><li>Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.</li><li>Diagnosis of clinically significant agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.</li></ul>

Exclusion

<p>Exclusion Criteria:</p><ul><li>Patient has dementia predominantly of non-Alzheimer's type.</li><li>Unable to comply with study procedures.</li><li>Medically inappropriate for study participation in the opinion of the investigator.</li></ul>

Study Design

Study Start date:
Estimated Completion Date:

Study Description

<p><span style="background-color:rgb(255,255,255);color:rgb(23,23,22);">This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of </span><strong>AXS-05</strong><span style="background-color:rgb(255,255,255);color:rgb(23,23,22);"> compared to placebo for the treatment of agitation associated with Alzheimer's disease.</span></p><p>Eligible subjects will be randomized in a 1:1 ratio for up to 5 weeks to be treated with AXS-05 or placebo.</p>

Connect with a study center

  • Mid Hudson Medical Research, PLLC

    New Windsor, New York 12553
    United States

    Active - Recruiting

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