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

May 29, 2026 updated by: Axsome Therapeutics, Inc.
The primary objective of this open-label extension trial was to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 or ACCORD-2.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This was 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 continued to receive AXS-05 given completion of ADVANCE-2 (AXS-05-AD-304) or ACCORD-2 (AXS-05-AD-303).

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Clinical Research Site
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Clinical Research Site
    • California
      • Walnut Creek, California, United States, 94596
        • Clinical Research Site
    • Florida
      • Bonita Springs, Florida, United States, 34134
        • Clinical Research Site
      • Brandon, Florida, United States, 33511
        • Clinical Research Site
      • Greenacres City, Florida, United States, 33467
        • Clinical Research Site
      • Hialeah, Florida, United States, 33012
        • Clinical Research Site
      • Miami, Florida, United States, 33155
        • Clinical Research Site
      • Miami, Florida, United States, 33126
        • Clinical Research Site
      • Miami, Florida, United States, 33145
        • Clinical Research Site
      • Miami, Florida, United States, 33165
        • Clinical Research Site
      • Miami, Florida, United States, 33173
        • Clinical Research Site
      • Miami Gardens, Florida, United States, 33014
        • Clinical Research Site
      • Miami Lakes, Florida, United States, 33014
        • Clinical Research Site
      • Pembroke Pines, Florida, United States, 33025
        • Clinical Research Site
      • Tampa, Florida, United States, 33634
        • Clinical Research Site
      • Tampa, Florida, United States, 33614
        • Clinical Research Site
    • Massachusetts
      • Braintree, Massachusetts, United States, 02184
        • Clinical Research Site
    • New York
      • Brooklyn, New York, United States, 11229
        • Clinical Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Clinical Research Site
    • Texas
      • Mesquite, Texas, United States, 75149
        • Clinical Research Site
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Completed the treatment period in Study AXS-05-AD-304 or exited from Study AXS-05-AD-303 due to study completion.
  • Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment.

Exclusion Criteria:

  • Caregiver is unwilling or unable, in the opinion of the Investigator, to comply with study instructions.
  • Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), 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-303 which may pose a safety risk when taken concurrently with AXS-05.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-Label
Experimental: AXS-05 (dextromethorphan-bupropion) up to 25 weeks
Drug: AXS-05 (dextromethorphan-bupropion)
AXS-05 tablets, taken twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-Term Safety
Time Frame: Up to 25 weeks
Incidence of treatment-emergent adverse events following dosing with AXS-05
Up to 25 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2024

Primary Completion (Actual)

February 17, 2025

Study Completion (Actual)

April 25, 2025

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

December 16, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS-05-AD-305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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