Addressing Dementia Via Agitation-Centered Evaluation

Last updated: August 22, 2023
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Completed

Phase

2/3

Condition

Dementia

Williams Syndrome

Manic Disorders

Treatment

AXS-05

Placebo

Bupropion

Clinical Study ID

NCT03226522
AXS-05-AD-301
  • Ages 65-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

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

Exclusion

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 Design

Total Participants: 366
Treatment Group(s): 3
Primary Treatment: AXS-05
Phase: 2/3
Study Start date:
July 13, 2017
Estimated Completion Date:
April 17, 2020

Connect with a study center

  • Axsome study site

    Caulfield, Melbourne, Victoria 3162
    Australia

    Site Not Available

  • Axsome Study Site

    Gilbert, Arizona 85297
    United States

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  • Axsome Study Site

    Phoenix, Arizona 85004
    United States

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  • Axsome study site

    Scottsdale, Arizona 85251
    United States

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  • Axsome Study Site

    Tucson, Arizona 85704
    United States

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  • Axsome Study Site

    Little Rock, Arkansas 72209
    United States

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  • Axsome study site

    Canoga Park, California 91303
    United States

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  • Axsome study site

    Costa Mesa, California 92626
    United States

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  • Axsome study site

    Fresno, California 93710
    United States

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  • Axsome study site

    Long Beach, California 90807
    United States

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  • Axsome Study Site

    Los Alamitos, California 90720
    United States

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  • Axsome study site

    Riverside, California 92503
    United States

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  • Axsome study site

    Sacramento, California 95821
    United States

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  • Axsome study site

    Santa Ana, California 92705
    United States

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  • Axsome Study Site

    Santa Clarita, California 91321
    United States

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  • Axsome study site

    Sherman Oaks, California 91403
    United States

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  • Axsome study site

    Simi Valley, California 93065
    United States

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  • Axsome study site

    Temecula, California 92591
    United States

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  • Axsome study site

    Ventura, California 93003
    United States

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  • Axsome Study Site

    Colorado Springs, Colorado 80910
    United States

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  • Axsome study site

    Cromwell, Connecticut 06416
    United States

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  • Axsome study site

    New London, Connecticut 06320
    United States

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  • Axsome Study Site

    Apopka, Florida 32703
    United States

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  • Axsome study site

    Boca Raton, Florida 33487
    United States

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  • Axsome study site

    Boynton Beach, Florida 33437
    United States

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  • Meridian Research

    Brooksville, Florida 34601
    United States

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  • Axsome Study Site

    Coconut Creek, Florida 33066
    United States

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  • Axsome Study Site

    Greenacres City, Florida 33467
    United States

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  • Axsome study site

    Hallandale Beach, Florida 33009
    United States

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  • Axsome study site

    Hialeah, Florida 33012
    United States

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  • Axsome Study Site

    Lake City, Florida 32055
    United States

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  • Axsome study site

    Miami, Florida 33165
    United States

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  • Axsome Study Site

    Orlando, Florida 32807
    United States

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  • Axsome study site

    Pensacola, Florida 32502
    United States

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  • Axsome Study Site

    Port Orange, Florida 32127
    United States

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  • Axsome study site

    Spring Hill, Florida 34609
    United States

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  • Axsome study site

    Tampa, Florida 33613
    United States

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  • Axsome study site

    Atlanta, Georgia 30331
    United States

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  • Axsome study site

    Decatur, Georgia 30030
    United States

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  • Axsome Study Site

    Honolulu, Hawaii 96817
    United States

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  • Axsome study site

    Boise, Idaho 83704
    United States

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  • Axsome Study Site

    Flossmoor, Illinois 60422
    United States

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  • Axsome study site

    Avon, Indiana 46123
    United States

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  • Axsome Study Site

    Overland Park, Kansas 66212
    United States

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  • Axsome Study Site

    Topeka, Kansas 66606
    United States

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  • Axsome study site

    Baton Rouge, Louisiana 70808
    United States

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  • Axsome Study Site

    Lake Charles, Louisiana 70629
    United States

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  • Axsome Study Site

    Hattiesburg, Mississippi 39401
    United States

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  • Axsome study site

    Chesterfield, Missouri 63005
    United States

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  • Axsome Study Site

    Saint Louis, Missouri 63128
    United States

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  • Axsome Study Site

    Las Vegas, Nevada 89109
    United States

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  • Axsome study site

    Las Vegas, Nevada 89102
    United States

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  • Axsome Study Site

    Princeton, New Jersey 08540
    United States

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  • Axsome study site

    Toms River, New Jersey 08755
    United States

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  • Axsome Study Site

    Albany, New York 12208
    United States

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  • Axsome study site

    Brooklyn, New York 11229
    United States

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  • Axsome study site

    New York, New York 10036
    United States

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  • Axsome study site

    Staten Island, New York 10312
    United States

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  • Axsome Study Site

    Charlotte, North Carolina 28211
    United States

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  • Axsome study site

    Charlotte, North Carolina 28270
    United States

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  • Axsome Study Site

    Winston-Salem, North Carolina 27103
    United States

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  • Axsome study site

    Cincinnati, Ohio 45069
    United States

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  • Axsome Study Site

    Dayton, Ohio 45459
    United States

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  • Axsome study site

    Shaker Heights, Ohio 44122
    United States

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  • Axsome Study Site

    Oklahoma City, Oklahoma 73112
    United States

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  • Axsome study site

    DeSoto, Texas 75115
    United States

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  • Axsome Study Site

    McKinney, Texas 75071
    United States

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  • Axsome study site

    Wichita Falls, Texas 76309
    United States

    Site Not Available

  • Axsome study site

    Orem, Utah 84058
    United States

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  • Axsome Study Site

    Charlottesville, Virginia 22903
    United States

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  • Axsome Study Site

    Richmond, Virginia 23235
    United States

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  • Axsome study site

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Axsome Study Site

    Everett, Washington 98201
    United States

    Site Not Available

  • Axsome study site

    Spokane, Washington 99202
    United States

    Site Not Available

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