- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05557409
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation (ADVANCE-2)
April 25, 2024 updated by: Axsome Therapeutics, Inc.
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
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
350
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Director
- Phone Number: 212-332-5061
- Email: ADVANCE-2@axsome.com
Study Locations
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Bayamon, Puerto Rico, 00961
- Recruiting
- Clinical Research Site
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San Juan, Puerto Rico, 00918
- Recruiting
- Clinical Research Site
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Arizona
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Peoria, Arizona, United States, 85381
- Recruiting
- Clinical Research Site
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Tempe, Arizona, United States, 85282
- Terminated
- Clinical Research Site
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Tucson, Arizona, United States, 85710
- Recruiting
- Clinical Research Site
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California
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Canoga Park, California, United States, 91303
- Recruiting
- Clinical Research Site
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Lafayette, California, United States, 94549
- Recruiting
- Clinical Research Site
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Long Beach, California, United States, 90807
- Recruiting
- Clinical Research Site
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Los Alamitos, California, United States, 90720
- Recruiting
- Clinical Research Site
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San Marcos, California, United States, 92069
- Withdrawn
- Clinical Research Site
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West Covina, California, United States, 91790
- Recruiting
- Clinical Research Site
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Florida
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Brandon, Florida, United States, 33511
- Recruiting
- Clinical Research Site
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Greenacres City, Florida, United States, 33467
- Recruiting
- Clinical Research Site
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Hialeah, Florida, United States, 33012
- Recruiting
- Clinical Research Site
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Hollywood, Florida, United States, 33024
- Recruiting
- Clinical Research Site
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Kissimmee, Florida, United States, 34741
- Recruiting
- Clinical Research Site
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Miami, Florida, United States, 33155
- Recruiting
- Clinical Research Site
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Miami, Florida, United States, 33175
- Recruiting
- Clinical Research Site
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Miami, Florida, United States, 33145
- Recruiting
- Clinical Research Site
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Miami, Florida, United States, 33126
- Recruiting
- Clinical Research Site
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Miami, Florida, United States, 33165
- Recruiting
- Clinical Research Site
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Miami, Florida, United States, 33135
- Recruiting
- Clinical Research Site
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Miami, Florida, United States, 33173
- Recruiting
- Clinical Research Site
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Miami Gardens, Florida, United States, 33014
- Recruiting
- Clinical Research Site
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Miami Lakes, Florida, United States, 33014
- Recruiting
- Clinical Research Site
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Orlando, Florida, United States, 32807
- Recruiting
- Clinical Research Site
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Pembroke Pines, Florida, United States, 33024
- Recruiting
- Clinical Research Site
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Georgia
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Augusta, Georgia, United States, 30912
- Recruiting
- Clinical Research Site
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Columbus, Georgia, United States, 31909
- Recruiting
- Clinical Research Site
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Kansas
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Wichita, Kansas, United States, 67214
- Recruiting
- Clinical Research Site
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Louisiana
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Marrero, Louisiana, United States, 70072
- Recruiting
- Clinical Research Site
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Massachusetts
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Braintree, Massachusetts, United States, 02184
- Recruiting
- Clinical Research Site
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Methuen, Massachusetts, United States, 01844
- Withdrawn
- Clinical Research Site
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Michigan
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Flint, Michigan, United States, 48532
- Recruiting
- Clinical Research Site
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Rochester Hills, Michigan, United States, 48307
- Recruiting
- Clinical Research Site
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Missouri
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Chesterfield, Missouri, United States, 63005
- Recruiting
- Clinical Research Site
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New Jersey
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Berlin, New Jersey, United States, 08009
- Recruiting
- Clinical Research Site
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Toms River, New Jersey, United States, 08755
- Recruiting
- Clinical Research Site
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New York
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Bronx, New York, United States, 10466
- Recruiting
- Clinical Research Site
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Brooklyn, New York, United States, 11229
- Recruiting
- Clinical Research Site
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New Windsor, New York, United States, 12553
- Recruiting
- Clinical Research Site
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Staten Island, New York, United States, 10312
- Recruiting
- Clinical Research Site
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Woodmere, New York, United States, 11598
- Recruiting
- Clinical Research Site
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North Carolina
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Charlotte, North Carolina, United States, 28211
- Recruiting
- Clinical Research Site
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Hickory, North Carolina, United States, 28601
- Recruiting
- Clinical Research Site
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Ohio
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Cincinnati, Ohio, United States, 45242
- Recruiting
- Clinical Research Site
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Middleburg Heights, Ohio, United States, 44130
- Recruiting
- Clinical Research Site
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Texas
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Austin, Texas, United States, 78737
- Recruiting
- Clinical Research Site
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Cypress, Texas, United States, 77429
- Recruiting
- Clinical Research Site
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Mesquite, Texas, United States, 75149
- Recruiting
- Clinical Research Site
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San Antonio, Texas, United States, 78229
- Recruiting
- Clinical Research Site
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Sugar Land, Texas, United States, 77478
- Recruiting
- Clinical Research Site
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Virginia
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Arlington, Virginia, United States, 22205
- Recruiting
- Clinical Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 90 years (Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AXS-05
Up to 5 weeks
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AXS-05 tablets, taken twice daily
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Placebo Comparator: Placebo
Up to 5 weeks
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Placebo tablets, taken twice daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cohen-Mansfield Agitation Inventory (CMAI)
Time Frame: Up to 5 weeks
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Up to 5 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2022
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
September 23, 2022
First Submitted That Met QC Criteria
September 23, 2022
First Posted (Actual)
September 28, 2022
Study Record Updates
Last Update Posted (Estimated)
April 26, 2024
Last Update Submitted That Met QC Criteria
April 25, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Psychomotor Disorders
- Tauopathies
- Aberrant Motor Behavior in Dementia
- Psychomotor Agitation
- Dementia
- Alzheimer Disease
Other Study ID Numbers
- AXS-05-AD-304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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