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NCT04947553 Clinical Trial

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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04947553
Other study ID # AXS-05-AD-303
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date June 17, 2021
Est. completion date December 2024

Study information
Verified date March 2024
Source Axsome Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

This study is a multi-center trial consisting of an open-label segment of up to 52 weeks, followed by a double-blind, placebo-controlled, randomized withdrawal segment. Subjects participating in the randomized-withdrawal segment will be randomized in a 1:1 ratio either to continue to receive AXS-05 or switch to placebo, for up to 24 weeks.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 300
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years to 90 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AXS-05 (dextromethorphan-bupropion)
AXS-05 tablets, taken twice daily
• Placebo
Placebo tablets, taken twice daily

Locations
Country Name City State
Canada Clinical Research Site Kelowna British Columbia
United States Clinical Research Site Arlington Virginia
United States Clinical Research Site Austin Texas
United States Clinical Research Site Brandon Florida
United States Clinical Research Site Brooklyn New York
United States Clinical Research Site Chesterfield Missouri
United States Clinical Research Site Columbus Georgia
United States Clinical Research Site Coral Springs Florida
United States Clinical Research Site Cypress Texas
United States Clinical Research Site Flint Michigan
United States Clinical Research Site Greenacres City Florida
United States Clinical Research Site Hialeah Florida
United States Clinical Research Site Hickory North Carolina
United States Clinical Research Site Hollywood Florida
United States Clinical Research Site Kissimmee Florida
United States Clinical Research Site Lafayette California
United States Clinical Research Site Lake City Florida
United States Clinical Research Site Long Beach California
United States Clinical Research Site McKinney Texas
United States Clinical Research Site Miami Florida
United States Clinical Research Site Miami Florida
United States Clinical Research Site Miami Florida
United States Clinical Research Site Miami Florida
United States Clinical Research Site Miami Florida
United States Clinical Research Site Miami Florida
United States Clinical Research Site Miami Florida
United States Clinical Research Site Miami Gardens Florida
United States Clinical Research Site Miami Lakes Florida
United States Clinical Research Site New Windsor New York
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Pembroke Pines Florida
United States Clinical Research Site Peoria Arizona
United States Clinical Research Site Rochester Hills Michigan
United States Clinical Research Site Santa Ana California
United States Clinical Research Site Staten Island New York
United States Clinical Research Site Sugar Land Texas
United States Clinical Research Site Temecula California
United States Clinical Research Site Toms River New Jersey
United States Clinical Research Site Trinity Florida
United States Clinical Research Site Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Axsome Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Other Cohen-Mansfield Agitation Inventory (CMAI) Change from Baseline to last dose in the CMAI up to 76 weeks
Primary Long-term Safety Incidence of treatment-emergent adverse events following dosing with AXS-05 up to 76 weeks
Primary Time to relapse of agitation symptoms up to 24 weeks
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