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AXS-05 for Agitation in Alzheimer's

Recruiting

This Phase II/III randomized trial will assess the efficacy and safety of AXS-05, an investigational drug combining FDA-approved bupropion and dextromethorphan, to treat agitation in older adults with Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
65 Years 90 Years All No
July 13, 2017
June 2020
435

  • Diagnosis of probable Alzheimer's disease
  • Diagnosis of significant agitation resulting from probable Alzheimer's disease

  • Dementia other than Alzheimer's
  • Inability to comply with study procedures
  • Medically inappropriate for study participation

AXS-05 is an investigational drug combining bupropion, a drug approved to treat depression, and dextromethorphan, an active ingredient in some cough medicines. Researchers are exploring this treatment for Alzheimer's-related agitation, characterized by emotional distress, aggressive behaviors, disruptive irritability, and disinhibition. This study will compare the effectiveness of AXS-05 to that of bupropion alone or a placebo. Participants will take a pill of either the study drug or a placebo once daily by mouth for 5 weeks.

For more information about this study or study sites, contact Axsome Clinical Trials at 212-332-3241 or ADVANCE-1@axsome.com.

Name City State Zip Status Primary Contact
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Phoenix Arizona 85004 Recruiting

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Scottsdale Arizona 85251 Recruiting

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Scottsdale Arizona 85258 Recruiting

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Tucson Arizona 85704 Active, not recruiting

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Little Rock Arkansas 72209 Recruiting

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Canoga Park California 91303 Recruiting

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Costa Mesa California 92626 Recruiting

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Fresno California 93710 Recruiting

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Long Beach California 90806 Recruiting

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Long Beach California 90807 Recruiting

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Riverside California 92503 Recruiting

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Sacramento California 95821 Recruiting

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Santa Ana California 92705 Recruiting

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Sherman Oaks California 91403 Recruiting

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Simi Valley California 93065 Recruiting

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Temecula California 92591 Recruiting

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Ventura California 93003 Recruiting

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Colorado Springs Colorado 80910 Active, not recruiting

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Cromwell Connecticut 06416 Recruiting

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New London Connecticut 06320 Recruiting

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Boca Raton Florida 33487 Recruiting

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Boynton Beach Florida 33437 Active, not recruiting

Meridian Research
Brooksville Florida 34601 Recruiting Research Director

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Coconut Creek Florida 33066 Active, not recruiting

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Hallandale Beach Florida 33009 Recruiting

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Hialeah Florida 33012 Recruiting

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Lake City Florida 32055 Recruiting

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Miami Florida 33122 Recruiting

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Miami Florida 33165 Recruiting

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Pensacola Florida 32502 Recruiting

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Spring Hill Florida 34609 Recruiting

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Tampa Florida 33609 Recruiting

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Tampa Florida 33613 Active, not recruiting

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Atlanta Georgia 30331 Recruiting

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Decatur Georgia 30030 Recruiting

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Honolulu Hawaii 96817 Active, not recruiting

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Boise Idaho 83704 Recruiting

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Flossmoor Illinois 60422 Active, not recruiting

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Avon Indiana 46123 Recruiting

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Overland Park Kansas 66212 Recruiting

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Topeka Kansas 66606 Recruiting

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Baton Rouge Louisiana 70808 Recruiting

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Lake Charles Louisiana 70629 Recruiting

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Chesterfield Missouri 63005 Recruiting

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Las Vegas Nevada 89102 Recruiting

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Princeton New Jersey 08540 Recruiting

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Toms River New Jersey 08755 Recruiting

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Brooklyn New York 11229 Recruiting

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New York New York 10036 Recruiting

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New York New York 10128 Active, not recruiting

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Staten Island New York 10312 Recruiting

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Charlotte North Carolina 28270 Recruiting

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Winston-Salem North Carolina 27103 Recruiting

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Cincinnati Ohio 45069 Recruiting

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Shaker Heights Ohio 44122 Recruiting

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DeSoto Texas 75115 Recruiting

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Wichita Falls Texas 76309 Active, not recruiting

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Orem Utah 84058 Recruiting

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Charlottesville Virginia 22903 Active, not recruiting

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Bellevue Washington 98007 Recruiting

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Spokane Washington 99202 Recruiting

Axsome Therapeutics, Inc.

Name Phone Email
Axsome Clinical Trials 212-332-3241 ADVANCE-1@axsome.com

NCT03226522

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