Assessing Clinical Outcomes in Alzheimer's Disease Agitation (ACCORD)

November 27, 2023 updated by: Axsome Therapeutics, Inc.

A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

178

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

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Clinical Research Site
    • Ontario
      • Newmarket, Ontario, Canada, L3Y G8
        • Clinical Research Site
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Clinical Research Site
      • Tucson, Arizona, United States, 85710
        • Clinical Research Site
    • California
      • Chula Vista, California, United States, 91910
        • Clinical Research Site
      • Imperial, California, United States, 92251
        • Clinical Research Site
      • Lafayette, California, United States, 94549
        • Clinical Research Site
      • Los Alamitos, California, United States, 90720
        • Clinical Research Site
      • Los Angeles, California, United States, 90064
        • Clinical Research Site
      • Oceanside, California, United States, 92056
        • Clinical Research Site
      • San Diego, California, United States, 92103
        • Clinical Research Site
      • Santa Ana, California, United States, 92705
        • Clinical Research Site
      • Temecula, California, United States, 92591
        • Clinical Research Site
    • Florida
      • Coral Springs, Florida, United States, 33067
        • Clinical Research Site
      • Hialeah, Florida, United States, 33012
        • Clinical Research Site
      • Kissimmee, Florida, United States, 34741
        • Clinical Research Site
      • Lake City, Florida, United States, 32055
        • Clinical Research Site
      • Miami, Florida, United States, 33155
        • Clinical Research Site
      • Miami, Florida, United States, 33175
        • Clinical Research Site
      • Miami, Florida, United States, 48532
        • Clinical Research Site
      • Miami Lakes, Florida, United States, 33014
        • Clinical Research Site
      • Naples, Florida, United States, 34105
        • Clinical Research Site
      • Ocoee, Florida, United States, 34761
        • Clinical Research Site
      • Orlando, Florida, United States, 32807
        • Clinical Research Site
      • Orlando, Florida, United States, 32819
        • Clinical Research Site
      • Pembroke Pines, Florida, United States, 33024
        • Clinical Research Site
      • Pensacola, Florida, United States, 32502
        • Clinical Research Site
      • Saint Petersburg, Florida, United States, 33709
        • Clinical Research Site
      • Sunrise, Florida, United States, 33351
        • Clinical Research Site
      • Tampa, Florida, United States, 33634
        • Clinical Research Site
      • Trinity, Florida, United States, 34655
        • Clinical Research Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Clinical Research Site
      • Columbus, Georgia, United States, 31909
        • Clinical Research Site
      • Suwanee, Georgia, United States, 30024
        • Clinical Research Site
    • Hawaii
      • Honolulu, Hawaii, United States, 92103
        • Clinical Research Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Clinical Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Clinical Research Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Clinical Research Site
    • Massachusetts
      • Lowell, Massachusetts, United States, 01852
        • Clinical Research Site
    • Michigan
      • Flint, Michigan, United States, 48532
        • Clinical Research Site
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Clinical Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Clinical Research Site
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Clinical Research Site
    • New York
      • Brooklyn, New York, United States, 11229
        • Clinical Research Site
      • East Syracuse, New York, United States, 13057
        • Clinical Research Site
      • New Windsor, New York, United States, 12553
        • Clinical Research Site
      • New York, New York, United States, 10036
        • Clinical Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Clinical Research Site
      • Hickory, North Carolina, United States, 28601
        • Clinical Research Site
    • Ohio
      • Dayton, Ohio, United States, 45459
        • Clinical Research Site
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Clinical Research Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Clinical Research Site
    • Texas
      • Austin, Texas, United States, 78737
        • Clinical Research Site
      • Cypress, Texas, United States, 77429
        • Clinical Research Site
      • Houston, Texas, United States, 77074
        • Clinical Research Site
      • McKinney, Texas, United States, 75071
        • Clinical Research Site
      • Mesquite, Texas, United States, 75149
        • Clinical Research Site
      • San Antonio, Texas, United States, 78229
        • Clinical Research Site
      • Sugar Land, Texas, United States, 77479
        • Clinical Research Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • Clinical Research Site
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Clinical Research Site
    • Washington
      • Everett, Washington, United States, 98201
        • Clinical Research Site
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • 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

63 years to 88 years (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
  • Diagnosis of clinically signification agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.

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, other psychiatric disorder or delirium due to a metabolic disorder, systemic infection, or substance-induced).
  • Unable to comply with study procedures.
  • Medically inappropriate for study participation in the opinion of the investigator.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AXS-05
Up to 26 weeks in double-blind period
Drug: AXS-05
AXS-05 tablets, taken twice daily
Placebo Comparator: Placebo
Up to 26 weeks in double-blind period
Drug: Placebo
Placebo tablets, taken twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from randomization to relapse of agitation symptoms
Time Frame: up to 26 weeks
up to 26 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Types and rates of adverse events
Time Frame: up to 35 weeks
up to 35 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)

December 31, 2020

Primary Completion (Actual)

November 21, 2022

Study Completion (Actual)

November 21, 2022

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS-05-AD-302

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

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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