Addressing Dementia Via Agitation-Centered Evaluation



Status:Recruiting
Conditions:Alzheimer Disease, Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:65 - 90
Updated:3/30/2019
Start Date:July 13, 2017
End Date:September 2019
Contact:Axsome Clinical Trials
Email:ADVANCE-1@axsome.com
Phone:+1 (212) 332-3241

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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.


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.
We found this trial at
57
sites
Tampa, Florida 33609
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Atlanta, Georgia 30331
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Atlanta, GA
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Avon, Indiana 46123
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Avon, IN
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Baton Rouge, Louisiana 70808
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Bellevue, Washington 98007
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Boca Raton, Florida 33487
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Boise, Idaho 83704
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Boynton Beach, Florida 33437
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Brooklyn, New York 11229
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Brooksville, Florida 34601
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Canoga Park, California 91303
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Caulfield, Melbourne, Victoria
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Charlotte, North Carolina 28270
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Charlotte, NC
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Charlottesville, Virginia 22903
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Charlottesville, VA
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Chesterfield, Missouri 63005
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Cincinnati, Ohio 45069
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Cincinnati, OH
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Coconut Creek, Florida 33066
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Colorado Springs, Colorado 80910
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Costa Mesa, California 92626
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Cromwell, Connecticut 06416
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Decatur, Georgia 30030
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DeSoto, Texas 75115
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Flossmoor, Illinois 60422
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Fresno, California 93710
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Hallandale Beach, Florida 33009
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Hialeah, Florida 33012
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Honolulu, Hawaii 96817
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Lake Charles, Louisiana 70629
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Lake City, Florida 32055
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Las Vegas, Nevada 89102
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Little Rock, Arkansas 72209
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Long Beach, California 90806
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Miami, Florida 33165
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New London, Connecticut 06320
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New York, New York 10036
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1215 South 1680 West
Orem, Utah 84058
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Orem, UT
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Overland Park, Kansas 66212
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Overland Park, KS
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Pensacola, Florida 32502
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Phoenix, Arizona 85004
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Princeton, New Jersey 08540
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Riverside, California 92503
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Sacramento, California 95821
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Santa Ana, California 92705
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Scottsdale, Arizona 85251
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Shaker Heights, Ohio 44122
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Sherman Oaks, California 91403
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Simi Valley, California 93065
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Spokane, Washington 99202
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Spring Hill, Florida 34609
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Staten Island, New York 10312
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Temecula, California 92591
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Toms River, New Jersey 08755
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Topeka, Kansas 66606
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Tucson, Arizona 85704
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Ventura, California 93003
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Wichita Falls, Texas 76309
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Winston-Salem, North Carolina 27103
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