An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study

Last updated: May 19, 2025
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Terminated

Phase

3

Condition

Manic Disorders

Dementia

Williams Syndrome

Treatment

AXS-05 (dextromethorphan-bupropion)

Clinical Study ID

NCT06736509
AXS-05-AD-305
  • Ages 65-90
  • All Genders

Study Summary

The primary objective of this open-label extension trial is to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 and ACCORD-2.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completed the treatment period in Study AXS-05-AD-304 or exited from StudyAXS-05-AD-303 due to study completion.

  • 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-304 and/or AXS-05-AD-303which may pose a safety risk when taken concurrently with AXS-05.

Study Design

Total Participants: 139
Treatment Group(s): 1
Primary Treatment: AXS-05 (dextromethorphan-bupropion)
Phase: 3
Study Start date:
November 21, 2024
Estimated Completion Date:
April 25, 2025

Study Description

This is a multi-center, open-label extension trial to evaluate the long-term safety of AXS-05 in subjects with Alzheimer's disease (AD) agitation that wish to continue to receive AXS-05 given completion of ADVANCE-2 (AXS-05-AD-304) and ACCORD-2 (AXS-05-AD-303).

Connect with a study center

  • 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

    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

    Green Acres, Florida 33467
    United States

    Site Not Available

  • Clinical Research Site

    Hialeah, Florida 33012
    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

    Pembroke Pines, Florida 33025
    United States

    Site Not Available

  • Clinical Research Site

    Tampa, Florida 33614
    United States

    Site Not Available

  • Clinical Research Site

    Braintree, Massachusetts 02184
    United States

    Site Not Available

  • Clinical Research Site

    Brooklyn, New York 11229
    United States

    Site Not Available

  • Clinical Research Site

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Clinical Research Site

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Clinical Research Site

    Arlington, Virginia 22205
    United States

    Site Not Available

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