A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

NCT04947553 | Completed Phase 3 FDA Drug

• 1 other identifier: AXS-05-AD-303
• Study Type: interventional
• Target: 456
• Locations: 3 countries
• Sites: 47

Brief Summary

This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.

Conditions

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

Keywords

AD agitation; AXS-05; NMDA receptor antagonist; dextromethorphan; bupropion; Axsome

Outcome Measures

Primary Outcomes (2)

• Long-term Safety

  Incidence of treatment-emergent adverse events following dosing with AXS-05

  up to 76 weeks

• Time to relapse of agitation symptoms

  up to 24 weeks

Other Outcomes (1)

• Cohen-Mansfield Agitation Inventory (CMAI)

  up to 76 weeks

Study Arms (2)

AXS-05 (dextromethorphan-bupropion)

EXPERIMENTAL

* Up to 52 weeks in the open-label segment; * Up to 24 weeks in the randomized double-blind segment (if applicable)

Drug: AXS-05 (dextromethorphan-bupropion)

Placebo

PLACEBO COMPARATOR

Up to 24 weeks in the randomized double-blind segment (if applicable)

Drug: Placebo

Interventions

AXS-05 (dextromethorphan-bupropion) DRUG

AXS-05 tablets, taken twice daily

AXS-05 (dextromethorphan-bupropion)

Placebo DRUG

Placebo tablets, taken twice daily

Placebo

Eligibility Criteria

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

You may qualify if:

• Participation in Study AXS-05-AD-302 or Study AXS-05-AD-304.
• Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment.

You may not qualify if:

• Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
• Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone.
• Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being.
• Initiation of a new medication since enrolling in AXS-05-AD-302 or AXS-05-AD-304 which may pose a safety risk when taken concurrently with AXS-05.

Sponsors & Collaborators

• Axsome Therapeutics, Inc.: lead

Study Sites (47)

Clinical Research Site

Peoria, Arizona, 83581, United States

Location

Clinical Research Site

Tempe, Arizona, 85282, United States

Location

Clinical Research Site

Long Beach, California, 90807, United States

Location

Clinical Research Site

Santa Ana, California, 92705, United States

Location

Clinical Research Site

Temecula, California, 92591, United States

Location

Clinical Research Site

Walnut Creek, California, 94596, United States

Location

Clinical Research Site

Bonita Springs, Florida, 34134, United States

Location

Clinical Research Site

Brandon, Florida, 33511, United States

Location

Clinical Research Site

Coral Springs, Florida, 33067, United States

Location

Clinical Research Site

Greenacres City, Florida, 33467, United States

Location

Clinical Research Site

Hialeah, Florida, 33012, United States

Location

Clinical Research Site

Hollywood, Florida, 33024, United States

Location

Clinical Research Site

Kissimmee, Florida, 34741, United States

Location

Clinical Research Site

Lake City, Florida, 32055, United States

Location

Clinical Research Site

Miami, Florida, 33126, United States

Location

Clinical Research Site

Miami, Florida, 33135, United States

Location

Clinical Research Site

Miami, Florida, 33145, United States

Location

Clinical Research Site

Miami, Florida, 33155, United States

Location

Clinical Research Site

Miami, Florida, 33165, United States

Location

Clinical Research Site

Miami, Florida, 33173, United States

Location

Clinical Research Site

Miami, Florida, 33175, United States

Location

Clinical Research Site

Miami Gardens, Florida, 33014, United States

Location

Clinical Research Site

Miami Lakes, Florida, 33014, United States

Location

Clinical Research Site

Orlando, Florida, 32807, United States

Location

Clinical Research Site

Pembroke Pines, Florida, 33025, United States

Location

Clinical Research Site

Tampa, Florida, 33614, United States

Location

Clinical Research Site

Tampa, Florida, 33634, United States

Location

Clinical Research Site

Trinity, Florida, 34655, United States

Location

Clinical Research Site

Columbus, Georgia, 31909, United States

Location

Clinical Research Site

Wichita, Kansas, 67214, United States

Location

Clinical Research Site

Braintree, Massachusetts, 02184, United States

Location

Clinical Research Site

Flint, Michigan, 48532, United States

Location

Clinical Research Site

Rochester Hills, Michigan, 48307, United States

Location

Clinical Research Site

Chesterfield, Missouri, 63005, United States

Location

Clinical Research Site

Toms River, New Jersey, 08755, United States

Location

Clinical Research Site

Brooklyn, New York, 11229, United States

Location

Clinical Research Site

New Windsor, New York, 12553, United States

Location

Clinical Research Site

Staten Island, New York, 10314, United States

Location

Clinical Research Site

Charlotte, North Carolina, 28211, United States

Location

Clinical Research Site

Hickory, North Carolina, 28601, United States

Location

Clinical Research Site

Austin, Texas, 78737, United States

Location

Clinical Research Site

Cypress, Texas, 77429, United States

Location

Clinical Research Site

Mesquite, Texas, 75149, United States

Location

Clinical Research Site

Sugar Land, Texas, 77478, United States

Location

Clinical Research Site

Arlington, Virginia, 22205, United States

Location

Clinical Research Site

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Clinical Research Site

San Juan, 00918, Puerto Rico

Location

Related Links

• Axsome Therapeutics Website

MeSH Terms

Conditions

Alzheimer Disease; Psychomotor Agitation

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: June 24, 2021
• First Posted: July 1, 2021
• Study Start: June 17, 2021
• Primary Completion: December 3, 2024
• Study Completion: December 21, 2024
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (45); CA (1)