A Study to Assess the Long-term Safety and Efficacy 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

Dementia

Williams Syndrome

Manic Disorders

Treatment

AXS-05 (dextromethorphan-bupropion)

Placebo

Clinical Study ID

NCT04947553
AXS-05-AD-303
  • Ages 65-90
  • All Genders

Study Summary

This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participation in Study AXS-05-AD-302 or Study AXS-05-AD-304.

  • Caregiver is willing to communicate with site personnel, comply with all requiredstudy procedures, and oversee administration and compliance with the subject's studytreatment.

Exclusion

Exclusion Criteria:

  • Caregiver is unwilling or unable, in the opinion of the investigator, to comply withstudy instructions.

  • Subject is hospitalized in a mental health facility (e.g., psychiatric hospital orward), living in a nursing home, or living alone.

  • Any concurrent medical condition that might interfere with the conduct of the study,confound the interpretation of study results, or endanger the subject's well-being.

  • Initiation of a new medication since enrolling in AXS-05-AD-302 or AXS-05-AD-304which may pose a safety risk when taken concurrently with AXS-05.

Study Design

Total Participants: 456
Treatment Group(s): 2
Primary Treatment: AXS-05 (dextromethorphan-bupropion)
Phase: 3
Study Start date:
June 17, 2021
Estimated Completion Date:
December 21, 2024

Study Description

This study is a multi-center trial consisting of an open-label segment of up to 52 weeks, followed by a double-blind, placebo-controlled, randomized withdrawal segment. Subjects participating in the randomized-withdrawal segment will be randomized in a 1:1 ratio either to continue to receive AXS-05 or switch to placebo, for up to 24 weeks.

Connect with a study center

  • Clinical Research Site

    Kelowna, British Columbia V1Y 1Z9
    Canada

    Site Not Available

  • Clinical Research Site

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Clinical Research Site

    Peoria, Arizona 83581
    United States

    Site Not Available

  • Clinical Research Site

    Tempe, Arizona 85282
    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

    Santa Ana, California 92705
    United States

    Site Not Available

  • Clinical Research Site

    Temecula, California 92591
    United States

    Site Not Available

  • Clinical Research Site

    Walnut Creek, California 94596
    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

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Clinical Research Site

    Greenacres, Florida 33467
    United States

    Site Not Available

  • Clinical Research Site

    Greenacres City, Florida 33467
    United States

    Site Not Available

  • Clinical Research Site

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Clinical Research Site

    Hollywood, Florida 33024
    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 33145
    United States

    Site Not Available

  • 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

    Site Not Available

  • Clinical Research Site

    Sunrise, Florida 33351
    United States

    Site Not Available

  • 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

    Columbus, Georgia 31909
    United States

    Site Not Available

  • Clinical Research Site

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Clinical Research Site

    Braintree, Massachusetts 02184
    United States

    Site Not Available

  • Clinical Research Site

    Flint, Michigan 48532
    United States

    Site Not Available

  • Clinical Research Site

    Rochester Hills, Michigan 48307
    United States

    Site Not Available

  • Clinical Research Site

    Chesterfield, Missouri 63005
    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

    New Windsor, New York 12553
    United States

    Site Not Available

  • Clinical Research Site

    Staten Island, New York 10314
    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

    Austin, Texas 78737
    United States

    Site Not Available

  • Clinical Research Site

    Cypress, Texas 77429
    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

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Clinical Research Site

    Arlington, Virginia 22205
    United States

    Site Not Available

  • Clinical Research Site

    Waukesha, Wisconsin 53188
    United States

    Site Not Available

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