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

Last updated: November 20, 2025
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Williams Syndrome

Dementia

Manic Disorders

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

    Bayamón 4562831, 00961
    Puerto Rico

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  • Clinical Research Site

    San Juan, 00918
    Puerto Rico

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  • Clinical Research Site

    San Juan 4568127, 00918
    Puerto Rico

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  • Clinical Research Site

    Peoria, Arizona 85381
    United States

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  • Clinical Research Site

    Tempe, Arizona 85282
    United States

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  • Clinical Research Site

    Tucson, Arizona 85710
    United States

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  • Clinical Research Site

    Peoria 5308480, Arizona 5551752 85381
    United States

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  • Clinical Research Site

    Tempe 5317058, Arizona 5551752 85282
    United States

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  • Clinical Research Site

    Tucson 5318313, Arizona 5551752 85710
    United States

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  • Clinical Research Site

    Canoga Park, California 91303
    United States

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  • Clinical Research Site

    Lafayette, California 94549
    United States

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  • Clinical Research Site

    Long Beach, California 90807
    United States

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  • Clinical Research Site

    Los Alamitos, California 90720
    United States

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  • Clinical Research Site

    San Marcos, California 92069
    United States

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  • Clinical Research Site

    Walnut Creek, California 94596
    United States

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  • Clinical Research Site

    West Covina, California 91790
    United States

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  • Clinical Research Site

    Canoga Park 5333913, California 5332921 91303
    United States

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  • Clinical Research Site

    Long Beach 5367929, California 5332921 90807
    United States

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  • Clinical Research Site

    Los Alamitos 5368304, California 5332921 90720
    United States

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  • Clinical Research Site

    Walnut Creek 5406990, California 5332921 94596
    United States

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  • Clinical Research Site

    West Covina 5407933, California 5332921 91790
    United States

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  • Clinical Research Site

    Bonita Springs, Florida 34134
    United States

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  • Clinical Research Site

    Brandon, Florida 33511
    United States

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    Green Acres, Florida 33467
    United States

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    Greenacres City, Florida 33467
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    Hialeah, Florida 33012
    United States

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    Hollywood, Florida 33024
    United States

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    Kissimmee, Florida 34741
    United States

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    Miami, Florida 33173
    United States

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    Miami Gardens, Florida 33014
    United States

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    Miami Lakes, Florida 33014
    United States

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    Orlando, Florida 32807
    United States

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    Pembroke Pines, Florida 33025
    United States

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    Sunrise, Florida 33351
    United States

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    Tampa, Florida 33634
    United States

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  • Clinical Research Site

    Bonita Springs 4148533, Florida 4155751 34134
    United States

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    Brandon 4148757, Florida 4155751 33511
    United States

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    Greenacres City 4157467, Florida 4155751 33467
    United States

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    Hialeah 4158476, Florida 4155751 33012
    United States

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  • Clinical Research Site

    Hollywood 4158928, Florida 4155751 33024
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    Kissimmee 4160983, Florida 4155751 34741
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    Miami 4164138, Florida 4155751 33126
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    Miami Gardens 4164167, Florida 4155751 33014
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    Miami Lakes 4164186, Florida 4155751 33014
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    Orlando 4167147, Florida 4155751 32807
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    Pembroke Pines 4168139, Florida 4155751 33025
    United States

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    Tampa 4174757, Florida 4155751 33614
    United States

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    Augusta, Georgia 30912
    United States

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    College Park, Georgia 30349
    United States

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    Columbus, Georgia 31909
    United States

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    Augusta 4180531, Georgia 4197000 30912
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    College Park 4188815, Georgia 4197000 30349
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    Columbus 4188985, Georgia 4197000 31909
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    Wichita, Kansas 67214
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    Wichita 4281730, Kansas 4273857 67214
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    Marrero, Louisiana 70072
    United States

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    Marrero 4332628, Louisiana 4331987 70072
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    Braintree, Massachusetts 02184
    United States

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    Methuen, Massachusetts 01844
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  • Clinical Research Site

    Braintree 7257540, Massachusetts 6254926 02184
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    Flint, Michigan 48532
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    Rochester Hills, Michigan 48307
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    Troy, Michigan 48085
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    Flint 4992982, Michigan 5001836 48532
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    Rochester Hills 5007402, Michigan 5001836 48307
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    Troy 5012639, Michigan 5001836 48085
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    Chesterfield, Missouri 63005
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    Chesterfield 4381072, Missouri 4398678 63005
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    Berlin, New Jersey 08009
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    Toms River, New Jersey 08755
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    Berlin 4500771, New Jersey 5101760 08009
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    Toms River 4504476, New Jersey 5101760 08755
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    Bronx, New York 10466
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    Brooklyn, New York 11229
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    New Windsor, New York 12553
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    Staten Island, New York 10312
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    Woodmere, New York 11598
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    Brooklyn 5110302, New York 5128638 11229
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    New Windsor 5128577, New York 5128638 12553
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  • Clinical Research Site

    Staten Island 5139568, New York 5128638 10312
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  • Clinical Research Site

    Woodmere 5145028, New York 5128638 11598
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    Charlotte, North Carolina 28211
    United States

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    Hickory, North Carolina 28601
    United States

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  • Clinical Research Site

    Charlotte 4460243, North Carolina 4482348 28211
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    Hickory 4470778, North Carolina 4482348 28601
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    Cincinnati, Ohio 45242
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    Middleburg Heights, Ohio 44130
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    Middleburg Heights 5162851, Ohio 5165418 44130
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    Austin, Texas 78737
    United States

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    Cypress, Texas 77429
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    Mesquite, Texas 75149
    United States

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  • Clinical Research Site

    San Antonio, Texas 78229
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    Sugar Land, Texas 77478
    United States

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    Sugarland, Texas 77478
    United States

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  • Clinical Research Site

    Austin 4671654, Texas 4736286 78737
    United States

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  • Clinical Research Site

    Cypress 4684724, Texas 4736286 77429
    United States

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  • Clinical Research Site

    Mesquite 4710826, Texas 4736286 75149
    United States

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  • Clinical Research Site

    San Antonio 4726206, Texas 4736286 78229
    United States

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  • Clinical Research Site

    Sugar Land 4734825, Texas 4736286 77478
    United States

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  • Clinical Research Site

    Rutland, Vermont 05701
    United States

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  • Clinical Research Site

    Rutland 5240509, Vermont 5242283 05701
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  • Clinical Research Site

    Arlington, Virginia 22205
    United States

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  • Clinical Research Site

    Arlington 4744709, Virginia 6254928 22205
    United States

    Site Not Available

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