Addressing Dementia Via Agitation-Centered Evaluation (ADVANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03226522
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : June 25, 2018
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Agitation in Patients With Dementia of the Alzheimer's Type Alzheimer Disease Agitation,Psychomotor Drug: AXS-05 Drug: Bupropion Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 435 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 13, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: AXS-05
AXS-05 tablets taken by mouth for 5 weeks.
Drug: AXS-05

Active Comparator: Bupropion
Bupropion tablets taken by mouth for 5 weeks.
Drug: Bupropion

Placebo Comparator: Placebo
Placebo tablets taken by mouth for 5 weeks.
Drug: Placebo

Primary Outcome Measures :
  1. Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 5 weeks ]
    Change from Baseline to Week 5 in the CMAI

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03226522

Contact: Axsome Clinical Trials +1 (212) 332-3241

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United States, Arizona
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Tucson, Arizona, United States, 85704
United States, Arkansas
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Little Rock, Arkansas, United States, 72209
United States, California
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Costa Mesa, California, United States, 92626
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Fresno, California, United States, 93710
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Long Beach, California, United States, 90806
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Long Beach, California, United States, 90807
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Santa Ana, California, United States, 92705
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Sherman Oaks, California, United States, 91403
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Simi Valley, California, United States, 93065
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Temecula, California, United States, 92591
United States, Colorado
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Colorado Springs, Colorado, United States, 80910
United States, Florida
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Boynton Beach, Florida, United States, 33437
Meridian Research Recruiting
Brooksville, Florida, United States, 34601
Contact: Research Director         
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Coconut Creek, Florida, United States, 33066
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Hallandale Beach, Florida, United States, 33009
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Hialeah, Florida, United States, 33012
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Lake City, Florida, United States, 32055
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Miami, Florida, United States, 33165
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Pensacola, Florida, United States, 32502
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Spring Hill, Florida, United States, 34609
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Tampa, Florida, United States, 33609
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Tampa, Florida, United States, 33613
United States, Georgia
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Atlanta, Georgia, United States, 30331
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Decatur, Georgia, United States, 30030
United States, Hawaii
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Honolulu, Hawaii, United States, 96817
United States, Illinois
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Flossmoor, Illinois, United States, 60422
United States, Kansas
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Overland Park, Kansas, United States, 66212
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Topeka, Kansas, United States, 66606
United States, Louisiana
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Lake Charles, Louisiana, United States, 70629
United States, Nevada
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Las Vegas, Nevada, United States, 89102
United States, New Jersey
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Princeton, New Jersey, United States, 08540
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Toms River, New Jersey, United States, 08755
United States, New York
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New York, New York, United States, 10036
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New York, New York, United States, 10128
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Staten Island, New York, United States, 10312
United States, North Carolina
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Charlotte, North Carolina, United States, 28270
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Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Shaker Heights, Ohio, United States, 44122
United States, Texas
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DeSoto, Texas, United States, 75115
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Wichita Falls, Texas, United States, 76309
United States, Utah
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Orem, Utah, United States, 84058
United States, Virginia
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Charlottesville, Virginia, United States, 22903
United States, Washington
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Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Axsome Therapeutics, Inc.

Additional Information:
Responsible Party: Axsome Therapeutics, Inc. Identifier: NCT03226522     History of Changes
Other Study ID Numbers: AXS-05-AD-301
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors