Addressing Dementia Via Agitation-Centered Evaluation

NCT03226522 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AXS-05-AD-301
• Study Type: interventional
• Target: 366
• Locations: 2 countries
• Sites: 78

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.

Conditions

Agitation in Patients With Dementia of the Alzheimer's Type; Alzheimer Disease; Agitation,Psychomotor

Outcome Measures

Primary Outcomes (1)

• Change in CMAI Total Score

  The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver-rated questionnaire that assesses the frequency of agitation-related and disruptive behaviors in subjects with dementia. The scale contains 29 behaviors or items organized into four subscales: physically aggressive, physically non-aggressive, verbally aggressive, and verbally non-aggressive. The CMAI is administered by interviewing the caregiver and asking him or her to rate the frequency with which the subject manifests each behavior using a seven-point scale: 1=never (better outcome), 7=several times an hour (worse outcome). The CMAI total score is the sum of the scores for all of the items in the CMAI. CMAI total scores range from a minimum of 29 (better outcome) to a maximum of 203 (worse outcome).

  5 weeks

Study Arms (3)

AXS-05

EXPERIMENTAL

AXS-05 tablets taken by mouth for 5 weeks.

Drug: AXS-05

Bupropion

ACTIVE COMPARATOR

Bupropion tablets taken by mouth for 5 weeks.

Drug: Bupropion

Placebo

PLACEBO COMPARATOR

Placebo tablets taken by mouth for 5 weeks.

Drug: Placebo

Interventions

AXS-05 DRUG

AXS-05

AXS-05

Bupropion DRUG

Bupropion

Bupropion

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Axsome Therapeutics, Inc.: lead

Study Sites (78)

Axsome Study Site

Gilbert, Arizona, 85297, United States

Location

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Phoenix, Arizona, 85004, United States

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Scottsdale, Arizona, 85251, United States

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Scottsdale, Arizona, 85258, United States

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Tucson, Arizona, 85704, United States

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Little Rock, Arkansas, 72209, United States

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Canoga Park, California, 91303, United States

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Costa Mesa, California, 92626, United States

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Fresno, California, 93710, United States

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Long Beach, California, 90806, United States

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Long Beach, California, 90807, United States

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Los Alamitos, California, 90720, United States

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Riverside, California, 92503, United States

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Sacramento, California, 95821, United States

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Santa Ana, California, 92705, United States

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Santa Clarita, California, 91321, United States

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Sherman Oaks, California, 91403, United States

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Simi Valley, California, 93065, United States

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Temecula, California, 92591, United States

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Ventura, California, 93003, United States

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Colorado Springs, Colorado, 80910, United States

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Cromwell, Connecticut, 06416, United States

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New London, Connecticut, 06320, United States

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Apopka, Florida, 32703, United States

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Boca Raton, Florida, 33487, United States

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Boynton Beach, Florida, 33437, United States

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Coconut Creek, Florida, 33066, United States

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Greenacres City, Florida, 33467, United States

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Hallandale, Florida, 33009, United States

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Hialeah, Florida, 33012, United States

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Lake City, Florida, 32055, United States

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Miami, Florida, 33122, United States

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Miami, Florida, 33165, United States

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Orlando, Florida, 32807, United States

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Pensacola, Florida, 32502, United States

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Port Orange, Florida, 32127, United States

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Spring Hill, Florida, 34609, United States

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Tampa, Florida, 33609, United States

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Tampa, Florida, 33613, United States

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Atlanta, Georgia, 30331, United States

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Decatur, Georgia, 30030, United States

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Honolulu, Hawaii, 96817, United States

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Boise, Idaho, 83704, United States

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Flossmoor, Illinois, 60422, United States

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Avon, Indiana, 46123, United States

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Overland Park, Kansas, 66212, United States

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Topeka, Kansas, 66606, United States

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Baton Rouge, Louisiana, 70808, United States

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Lake Charles, Louisiana, 70629, United States

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Hattiesburg, Mississippi, 39401, United States

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Chesterfield, Missouri, 63005, United States

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St Louis, Missouri, 63128, United States

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Las Vegas, Nevada, 89102, United States

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Las Vegas, Nevada, 89109, United States

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Princeton, New Jersey, 08540, United States

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Toms River, New Jersey, 08755, United States

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Albany, New York, 12208, United States

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Brooklyn, New York, 11229, United States

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New York, New York, 10036, United States

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New York, New York, 10128, United States

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Staten Island, New York, 10312, United States

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Charlotte, North Carolina, 28211, United States

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Charlotte, North Carolina, 28270, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45069, United States

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Dayton, Ohio, 45459, United States

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Shaker Heights, Ohio, 44122, United States

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Oklahoma City, Oklahoma, 73112, United States

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DeSoto, Texas, 75115, United States

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McKinney, Texas, 75071, United States

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Wichita Falls, Texas, 76309, United States

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Orem, Utah, 84058, United States

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Charlottesville, Virginia, 22903, United States

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Richmond, Virginia, 23235, United States

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Bellevue, Washington, 98007, United States

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Everett, Washington, 98201, United States

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Spokane, Washington, 99202, United States

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Caulfield, Melbourne, Victoria, 3162, Australia

Location

Related Links

• Axsome Therapeutics Website

MeSH Terms

Conditions

Alzheimer Disease; Psychomotor Agitation

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Dementia; 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; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Axsome Therapeutics

cstreicher@axsome.com

212-332-5061

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 21, 2017
• Study Start: July 13, 2017
• Primary Completion: April 17, 2020
• Study Completion: April 17, 2020
• Last Updated: September 13, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (77); AU (1)