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Addressing Dementia Via Agitation-Centered Evaluation (ADVANCE)

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ClinicalTrials.gov Identifier: NCT03226522
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : June 25, 2018
Sponsor:
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
AXS-05

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

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




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



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

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 ClinicalTrials.gov identifier (NCT number): NCT03226522


Contacts
Contact: Axsome Clinical Trials +1 (212) 332-3241 ADVANCE-1@axsome.com

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

Additional Information:
Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov 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
Dementia
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Bupropion
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