Assessing Clinical Outcomes in Alzheimer's Disease Agitation

Last updated: November 27, 2023
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Williams Syndrome

Manic Disorders

Dementia

Treatment

Placebo

AXS-05

Clinical Study ID

NCT04797715
AXS-05-AD-302
  • Ages 65-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute onAging-Alzheimer Association (NIA-AA) criteria.
  • Diagnosis of clinically signification 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.
  • Patient has symptoms of agitation that are not secondary to AD (e.g., pain, otherpsychiatric disorder or delirium due to a metabolic disorder, systemic infection, orsubstance-induced).
  • Unable to comply with study procedures.
  • Medically inappropriate for study participation in the opinion of the investigator.

Study Design

Total Participants: 178
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 31, 2020
Estimated Completion Date:
November 21, 2022

Study Description

Enrolled patients will first enter a 9-week, open-label stabilization period, during which they will be treated with AXS-05 and monitored for a treatment response. Patients who experience a treatment response during the stabilization period will then be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs.

Connect with a study center

  • Clinical Research Site

    Kelowna, British Columbia V1Y 1Z9
    Canada

    Site Not Available

  • Clinical Research Site

    Newmarket, Ontario L3Y G8
    Canada

    Site Not Available

  • Clinical Research Site

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Clinical Research Site

    Tucson, Arizona 85710
    United States

    Site Not Available

  • Clinical Research Site

    Chula Vista, California 91910
    United States

    Site Not Available

  • Clinical Research Site

    Imperial, California 92251
    United States

    Site Not Available

  • Clinical Research Site

    Lafayette, California 94549
    United States

    Site Not Available

  • Clinical Research Site

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Clinical Research Site

    Los Angeles, California 90064
    United States

    Site Not Available

  • Clinical Research Site

    Oceanside, California 92056
    United States

    Site Not Available

  • Clinical Research Site

    San Diego, California 92103
    United States

    Site Not Available

  • Clinical Research Site

    Santa Ana, California 92705
    United States

    Site Not Available

  • Clinical Research Site

    Temecula, California 92591
    United States

    Site Not Available

  • Clinical Research Site

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Clinical Research Site

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Clinical Research Site

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Clinical Research Site

    Lake City, Florida 32055
    United States

    Site Not Available

  • Clinical Research Site

    Miami, Florida 33155
    United States

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  • Clinical Research Site

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Clinical Research Site

    Naples, Florida 34105
    United States

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  • Clinical Research Site

    Ocoee, Florida 34761
    United States

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  • Clinical Research Site

    Orlando, Florida 32819
    United States

    Site Not Available

  • Clinical Research Site

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Clinical Research Site

    Pensacola, Florida 32502
    United States

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  • Clinical Research Site

    Saint Petersburg, Florida 33709
    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

    Site Not Available

  • Clinical Research Site

    Trinity, Florida 34655
    United States

    Site Not Available

  • Clinical Research Site

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Clinical Research Site

    Columbus, Georgia 31909
    United States

    Site Not Available

  • Clinical Research Site

    Suwanee, Georgia 30024
    United States

    Site Not Available

  • Clinical Research Site

    Honolulu, Hawaii 92103
    United States

    Site Not Available

  • Clinical Research Site

    Boise, Idaho 83704
    United States

    Site Not Available

  • Clinical Research Site

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Clinical Research Site

    Bangor, Maine 04401
    United States

    Site Not Available

  • Clinical Research Site

    Lowell, Massachusetts 01852
    United States

    Site Not Available

  • Clinical Research Site

    Flint, Michigan 48532
    United States

    Site Not Available

  • Clinical Research Site

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • Clinical Research Site

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Clinical Research Site

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Clinical Research Site

    Brooklyn, New York 11229
    United States

    Site Not Available

  • Clinical Research Site

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Clinical Research Site

    New Windsor, New York 12553
    United States

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  • Clinical Research Site

    New York, New York 10036
    United States

    Site Not Available

  • Clinical Research Site

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Clinical Research Site

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • Clinical Research Site

    Dayton, Ohio 45459
    United States

    Site Not Available

  • Clinical Research Site

    Jenkintown, Pennsylvania 19046
    United States

    Site Not Available

  • Clinical Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Clinical Research Site

    Austin, Texas 78737
    United States

    Site Not Available

  • Clinical Research Site

    Cypress, Texas 77429
    United States

    Site Not Available

  • Clinical Research Site

    Houston, Texas 77074
    United States

    Site Not Available

  • Clinical Research Site

    McKinney, Texas 75071
    United States

    Site Not Available

  • 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 77479
    United States

    Site Not Available

  • Clinical Research Site

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Clinical Research Site

    Woodstock, Vermont 05091
    United States

    Site Not Available

  • Clinical Research Site

    Everett, Washington 98201
    United States

    Site Not Available

  • Clinical Research Site

    Waukesha, Wisconsin 53188
    United States

    Site Not Available

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