Addressing Dementia Via Agitation-Centered Evaluation (ADVANCE)

August 22, 2023 updated by: Axsome Therapeutics, Inc.

A Randomized, Double-blind, Placebo-controlled 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, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

366

Phase

  • Phase 2
  • 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

  • Australia
    • Melbourne, Victoria
      • Caulfield, Melbourne, Victoria, Australia, 3162
        • Axsome study site
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Axsome study site
      • Phoenix, Arizona, United States, 85004
        • Axsome study site
      • Scottsdale, Arizona, United States, 85251
        • Axsome study site
      • Scottsdale, Arizona, United States, 85258
        • Axsome study site
      • Tucson, Arizona, United States, 85704
        • Axsome study site
    • Arkansas
      • Little Rock, Arkansas, United States, 72209
        • Axsome study site
    • California
      • Canoga Park, California, United States, 91303
        • Axsome study site
      • Costa Mesa, California, United States, 92626
        • Axsome study site
      • Fresno, California, United States, 93710
        • Axsome study site
      • Long Beach, California, United States, 90806
        • Axsome study site
      • Long Beach, California, United States, 90807
        • Axsome study site
      • Los Alamitos, California, United States, 90720
        • Axsome study site
      • Riverside, California, United States, 92503
        • Axsome study site
      • Sacramento, California, United States, 95821
        • Axsome study site
      • Santa Ana, California, United States, 92705
        • Axsome study site
      • Santa Clarita, California, United States, 91321
        • Axsome study site
      • Sherman Oaks, California, United States, 91403
        • Axsome study site
      • Simi Valley, California, United States, 93065
        • Axsome study site
      • Temecula, California, United States, 92591
        • Axsome study site
      • Ventura, California, United States, 93003
        • Axsome study site
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Axsome study site
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Axsome study site
      • New London, Connecticut, United States, 06320
        • Axsome study site
    • Florida
      • Apopka, Florida, United States, 32703
        • Axsome study site
      • Boca Raton, Florida, United States, 33487
        • Axsome study site
      • Boynton Beach, Florida, United States, 33437
        • Axsome study site
      • Coconut Creek, Florida, United States, 33066
        • Axsome study site
      • Greenacres City, Florida, United States, 33467
        • Axsome study site
      • Hallandale Beach, Florida, United States, 33009
        • Axsome study site
      • Hialeah, Florida, United States, 33012
        • Axsome study site
      • Lake City, Florida, United States, 32055
        • Axsome study site
      • Miami, Florida, United States, 33122
        • Axsome study site
      • Miami, Florida, United States, 33165
        • Axsome study site
      • Orlando, Florida, United States, 32807
        • Axsome study site
      • Pensacola, Florida, United States, 32502
        • Axsome study site
      • Port Orange, Florida, United States, 32127
        • Axsome study site
      • Spring Hill, Florida, United States, 34609
        • Axsome study site
      • Tampa, Florida, United States, 33609
        • Axsome study site
      • Tampa, Florida, United States, 33613
        • Axsome study site
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Axsome study site
      • Decatur, Georgia, United States, 30030
        • Axsome study site
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Axsome study site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Axsome study site
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • Axsome study site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Axsome study site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Axsome study site
      • Topeka, Kansas, United States, 66606
        • Axsome study site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Axsome study site
      • Lake Charles, Louisiana, United States, 70629
        • Axsome study site
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Axsome study site
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Axsome study site
      • Saint Louis, Missouri, United States, 63128
        • Axsome study site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Axsome study site
      • Las Vegas, Nevada, United States, 89109
        • Axsome study site
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Axsome study site
      • Toms River, New Jersey, United States, 08755
        • Axsome study site
    • New York
      • Albany, New York, United States, 12208
        • Axsome study site
      • Brooklyn, New York, United States, 11229
        • Axsome study site
      • New York, New York, United States, 10036
        • Axsome study site
      • New York, New York, United States, 10128
        • Axsome study site
      • Staten Island, New York, United States, 10312
        • Axsome study site
    • North Carolina
      • Charlotte, North Carolina, United States, 28270
        • Axsome study site
      • Charlotte, North Carolina, United States, 28211
        • Axsome study site
      • Winston-Salem, North Carolina, United States, 27103
        • Axsome study site
    • Ohio
      • Cincinnati, Ohio, United States, 45069
        • Axsome study site
      • Dayton, Ohio, United States, 45459
        • Axsome study site
      • Shaker Heights, Ohio, United States, 44122
        • Axsome study site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Axsome study site
    • Texas
      • DeSoto, Texas, United States, 75115
        • Axsome study site
      • McKinney, Texas, United States, 75071
        • Axsome study site
      • Wichita Falls, Texas, United States, 76309
        • Axsome study site
    • Utah
      • Orem, Utah, United States, 84058
        • Axsome study site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Axsome study site
      • Richmond, Virginia, United States, 23235
        • Axsome study site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Axsome study site
      • Everett, Washington, United States, 98201
        • Axsome study site
      • Spokane, Washington, United States, 99202
        • Axsome study 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

Key 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.
  • 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
AXS-05 tablets taken by mouth for 5 weeks.
Drug: AXS-05
AXS-05
Active Comparator: Bupropion
Bupropion tablets taken by mouth for 5 weeks.
Drug: Bupropion
Bupropion
Placebo Comparator: Placebo
Placebo tablets taken by mouth for 5 weeks.
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in CMAI Total Score
Time Frame: 5 weeks
The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver-rated questionnaire that assesses the frequency of agitation-related and disruptive behaviors in subjects with dementia. The scale contains 29 behaviors or items organized into four subscales: physically aggressive, physically non-aggressive, verbally aggressive, and verbally non-aggressive. The CMAI is administered by interviewing the caregiver and asking him or her to rate the frequency with which the subject manifests each behavior using a seven-point scale: 1=never (better outcome), 7=several times an hour (worse outcome). The CMAI total score is the sum of the scores for all of the items in the CMAI. CMAI total scores range from a minimum of 29 (better outcome) to a maximum of 203 (worse outcome).
5 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)

July 13, 2017

Primary Completion (Actual)

April 17, 2020

Study Completion (Actual)

April 17, 2020

Study Registration Dates

First Submitted

July 20, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS-05-AD-301

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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