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A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation (ADVANCE-2)

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: NCT05557409
Recruitment Status : Recruiting
First Posted : September 28, 2022
Last Update Posted : March 7, 2023
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Brief Summary:
This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.

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

Detailed Description:
Eligible subjects will be randomized in a 1:1 ratio for up to 5 weeks to be treated with AXS-05 or placebo.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: ADVANCE-2: Addressing Dementia Via Agitation-Centered Evaluation 2: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer's Disease Agitation
Actual Study Start Date : September 6, 2022
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: AXS-05
Up to 5 weeks
Drug: AXS-05
AXS-05 tablets, taken twice daily

Placebo Comparator: Placebo
Up to 5 weeks
Drug: Placebo
Placebo tablets, taken twice daily

Primary Outcome Measures :
  1. Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: Up to 5 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 significant 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): NCT05557409

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Contact: Study Director 212-332-5061

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United States, Arizona
Clinical Research Site Recruiting
Peoria, Arizona, United States, 85381
Clinical Research Site Recruiting
Tempe, Arizona, United States, 85282
United States, California
Clinical Research Site Recruiting
Long Beach, California, United States, 90807
Clinical Research Site Recruiting
San Marcos, California, United States, 92069
United States, Florida
Clinical Research Site Recruiting
Greenacres City, Florida, United States, 33467
Clinical Research Site Recruiting
Hialeah, Florida, United States, 33012
Clinical Research Site Recruiting
Kissimmee, Florida, United States, 34741
Clinical Research Site Recruiting
Miami Gardens, Florida, United States, 33014
Clinical Research Site Recruiting
Miami Lakes, Florida, United States, 33014
Clinical Research Site Recruiting
Miami, Florida, United States, 33125
Clinical Research Site Recruiting
Miami, Florida, United States, 33126
Clinical Research Site Recruiting
Miami, Florida, United States, 33145
Clinical Research Site Recruiting
Miami, Florida, United States, 33155
Clinical Research Site Recruiting
Miami, Florida, United States, 33165
Clinical Research Site Recruiting
Miami, Florida, United States, 33175
Clinical Research Site Recruiting
Sunrise, Florida, United States, 33351
United States, Georgia
Clinical Research Site Recruiting
Augusta, Georgia, United States, 30912
Clinical Research Site Recruiting
Columbus, Georgia, United States, 31909
United States, Kansas
Clinical Research Site Recruiting
Wichita, Kansas, United States, 67214
United States, Louisiana
Clinical Research Site Recruiting
Marrero, Louisiana, United States, 70072
United States, Massachusetts
Clinical Research Site Recruiting
Methuen, Massachusetts, United States, 01844
United States, Michigan
Clinical Research Site Recruiting
Flint, Michigan, United States, 48532
United States, Missouri
Clinical Research Site Recruiting
Chesterfield, Missouri, United States, 63005
United States, New Jersey
Clinical Research Site Recruiting
Toms River, New Jersey, United States, 08755
United States, New York
Clinical Research Site Recruiting
Brooklyn, New York, United States, 11229
Clinical Research Site Recruiting
New Windsor, New York, United States, 12553
Clinical Research Site Recruiting
Staten Island, New York, United States, 10312
United States, North Carolina
Clinical Research Site Recruiting
Charlotte, North Carolina, United States, 28211
Clinical Research Site Recruiting
Hickory, North Carolina, United States, 28601
United States, Ohio
Clinical Research Site Recruiting
Cincinnati, Ohio, United States, 45242
United States, Texas
Clinical Research Site Recruiting
Austin, Texas, United States, 78737
Clinical Research Site Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Axsome Therapeutics, Inc.
Additional Information:
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Responsible Party: Axsome Therapeutics, Inc. Identifier: NCT05557409    
Other Study ID Numbers: AXS-05-AD-304
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Axsome Therapeutics, Inc.:
AD agitation
NMDA receptor antagonist
Additional relevant MeSH terms:
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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