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

Last updated: January 15, 2025
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Williams Syndrome

Manic Disorders

Dementia

Treatment

Placebo

AXS-05

Clinical Study ID

NCT05557409
AXS-05-AD-304
  • Ages 65-90
  • All Genders

Study Summary

This trial is 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

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Instituteon Aging-Alzheimer Association (NIA-AA) criteria.

  • Diagnosis of clinically significant agitation resulting from probable AD accordingto the International Psychogeriatric Association (IPA) provisional definition ofagitation.

Exclusion

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.

Study Design

Total Participants: 408
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 06, 2022
Estimated Completion Date:
December 21, 2024

Study Description

Eligible subjects will be randomized in a 1:1 ratio for up to 5 weeks to be treated with AXS-05 or placebo.

Connect with a study center

  • Clinical Research Site

    Bayamon, 00961
    Puerto Rico

    Site Not Available

  • Clinical Research Site

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Clinical Research Site

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Clinical Research Site

    Tempe, Arizona 85282
    United States

    Site Not Available

  • Clinical Research Site

    Tucson, Arizona 85710
    United States

    Site Not Available

  • Clinical Research Site

    Canoga Park, California 91303
    United States

    Site Not Available

  • Clinical Research Site

    Lafayette, California 94549
    United States

    Site Not Available

  • Clinical Research Site

    Long Beach, California 90807
    United States

    Site Not Available

  • Clinical Research Site

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Clinical Research Site

    San Marcos, California 92069
    United States

    Site Not Available

  • Clinical Research Site

    Walnut Creek, California 94596
    United States

    Site Not Available

  • Clinical Research Site

    West Covina, California 91790
    United States

    Site Not Available

  • Clinical Research Site

    Bonita Springs, Florida 34134
    United States

    Site Not Available

  • Clinical Research Site

    Brandon, Florida 33511
    United States

    Site Not Available

  • Clinical Research Site

    Green Acres, Florida 33467
    United States

    Site Not Available

  • Clinical Research Site

    Greenacres City, Florida 33467
    United States

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  • Clinical Research Site

    Hialeah, Florida 33012
    United States

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  • Clinical Research Site

    Hollywood, Florida 33024
    United States

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  • Clinical Research Site

    Kissimmee, Florida 34741
    United States

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  • Clinical Research Site

    Miami, Florida 33135
    United States

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  • Clinical Research Site

    Miami Gardens, Florida 33014
    United States

    Site Not Available

  • Clinical Research Site

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Clinical Research Site

    Orlando, Florida 32807
    United States

    Site Not Available

  • Clinical Research Site

    Pembroke Pines, Florida 33025
    United States

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  • Clinical Research Site

    Sunrise, Florida 33351
    United States

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  • Clinical Research Site

    Tampa, Florida 33634
    United States

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  • Clinical Research Site

    Augusta, Georgia 30912
    United States

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  • Clinical Research Site

    College Park, Georgia 30349
    United States

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  • Clinical Research Site

    Columbus, Georgia 31909
    United States

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  • Clinical Research Site

    Wichita, Kansas 67214
    United States

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  • Clinical Research Site

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Clinical Research Site

    Braintree, Massachusetts 02184
    United States

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  • Clinical Research Site

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Clinical Research Site

    Flint, Michigan 48532
    United States

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  • Clinical Research Site

    Rochester Hills, Michigan 48307
    United States

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  • Clinical Research Site

    Troy, Michigan 48085
    United States

    Site Not Available

  • Clinical Research Site

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • Clinical Research Site

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Clinical Research Site

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Clinical Research Site

    Bronx, New York 10466
    United States

    Site Not Available

  • Clinical Research Site

    Brooklyn, New York 11229
    United States

    Site Not Available

  • Clinical Research Site

    New Windsor, New York 12553
    United States

    Site Not Available

  • Clinical Research Site

    Staten Island, New York 10312
    United States

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  • Clinical Research Site

    Woodmere, New York 11598
    United States

    Site Not Available

  • Clinical Research Site

    Charlotte, North Carolina 28211
    United States

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  • Clinical Research Site

    Hickory, North Carolina 28601
    United States

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  • Clinical Research Site

    Cincinnati, Ohio 45242
    United States

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  • Clinical Research Site

    Middleburg Heights, Ohio 44130
    United States

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  • Clinical Research Site

    Austin, Texas 78737
    United States

    Site Not Available

  • Clinical Research Site

    Cypress, Texas 77429
    United States

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  • Clinical Research Site

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Clinical Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Research Site

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Clinical Research Site

    Sugarland, Texas 77478
    United States

    Site Not Available

  • Clinical Research Site

    Rutland, Vermont 05701
    United States

    Site Not Available

  • Clinical Research Site

    Arlington, Virginia 22205
    United States

    Site Not Available

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