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AXS-05 for Agitation in Alzheimer's

Completed

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
April 17, 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
Axsome Study Site
Phoenix Arizona 85004

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Scottsdale Arizona 85251

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Scottsdale Arizona 85258

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Tucson Arizona 85704

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Little Rock Arkansas 72209

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Canoga Park California 91303

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Costa Mesa California 92626

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Fresno California 93710

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Long Beach California 90806

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Long Beach California 90807

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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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Sherman Oaks California 91403

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Simi Valley California 93065

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Temecula California 92591

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Ventura California 93003

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Colorado Springs Colorado 80910

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Cromwell Connecticut 06416

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New London Connecticut 06320

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Boca Raton Florida 33487

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Boynton Beach Florida 33437

Meridian Research
Brooksville Florida 34601

Axsome Study Site
Coconut Creek Florida 33066

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Hallandale Beach Florida 33009

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Hialeah Florida 33012

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Lake City Florida 32055

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Miami Florida 33122

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Miami Florida 33165

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Pensacola Florida 32502

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Spring Hill Florida 34609

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Tampa Florida 33609

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Tampa Florida 33613

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Atlanta Georgia 30331

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Decatur Georgia 30030

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Honolulu Hawaii 96817

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Boise Idaho 83704

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Flossmoor Illinois 60422

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Avon Indiana 46123

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Overland Park Kansas 66212

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Topeka Kansas 66606

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Baton Rouge Louisiana 70808

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Lake Charles Louisiana 70629

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Chesterfield Missouri 63005

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Las Vegas Nevada 89102

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Princeton New Jersey 08540

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Toms River New Jersey 08755

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Brooklyn New York 11229

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New York New York 10036

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New York New York 10128

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Staten Island New York 10312

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Charlotte North Carolina 28270

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Winston-Salem North Carolina 27103

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Cincinnati Ohio 45069

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Shaker Heights Ohio 44122

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DeSoto Texas 75115

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Wichita Falls Texas 76309

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Orem Utah 84058

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Charlottesville Virginia 22903

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Bellevue Washington 98007

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Spokane Washington 99202

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