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NCT04797715 Clinical Trial

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

Alzheimer Disease Clinical Trial

— ACCORD  

Official title:
A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04797715
Other study ID # AXS-05-AD-302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 31, 2020
Est. completion date November 21, 2022

Study information
Verified date November 2023
Source Axsome Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.

Description:

Enrolled patients will first enter a 9-week, open-label stabilization period, during which they will be treated with AXS-05 and monitored for a treatment response. Patients who experience a treatment response during the stabilization period will then be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs.

Recruitment information / eligibility
Status Completed
Enrollment 178
Est. completion date November 21, 2022
Est. primary completion date November 21, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years to 90 Years
Eligibility 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 signification 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. - Patient has symptoms of agitation that are not secondary to AD (e.g., pain, other psychiatric disorder or delirium due to a metabolic disorder, systemic infection, or substance-induced). - Unable to comply with study procedures. - Medically inappropriate for study participation in the opinion of the investigator.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AXS-05
AXS-05 tablets, taken twice daily
• Placebo
Placebo tablets, taken twice daily

Locations
Country Name City State
Canada Clinical Research Site Kelowna British Columbia
Canada Clinical Research Site Newmarket Ontario
United States Clinical Research Site Augusta Georgia
United States Clinical Research Site Austin Texas
United States Clinical Research Site Bangor Maine
United States Clinical Research Site Boise Idaho
United States Clinical Research Site Brooklyn New York
United States Clinical Research Site Charlotte North Carolina
United States Clinical Research Site Chesterfield Missouri
United States Clinical Research Site Chula Vista California
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 Dayton Ohio
United States Clinical Research Site East Syracuse New York
United States Clinical Research Site Everett Washington
United States Clinical Research Site Flint Michigan
United States Clinical Research Site Hialeah Florida
United States Clinical Research Site Hickory North Carolina
United States Clinical Research Site Honolulu Hawaii
United States Clinical Research Site Houston Texas
United States Clinical Research Site Imperial California
United States Clinical Research Site Jenkintown Pennsylvania
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 Las Vegas Nevada
United States Clinical Research Site Los Alamitos California
United States Clinical Research Site Los Angeles California
United States Clinical Research Site Lowell Massachusetts
United States Clinical Research Site McKinney Texas
United States Clinical Research Site Mesquite 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 Lakes Florida
United States Clinical Research Site Naples Florida
United States Clinical Research Site New Windsor New York
United States Clinical Research Site New York New York
United States Clinical Research Site Oceanside California
United States Clinical Research Site Ocoee Florida
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Pembroke Pines Florida
United States Clinical Research Site Pensacola Florida
United States Clinical Research Site Philadelphia Pennsylvania
United States Clinical Research Site Saint Petersburg Florida
United States Clinical Research Site San Antonio Texas
United States Clinical Research Site San Diego California
United States Clinical Research Site Santa Ana California
United States Clinical Research Site Sugar Land Texas
United States Clinical Research Site Sun City Arizona
United States Clinical Research Site Sunrise Florida
United States Clinical Research Site Suwanee Georgia
United States Clinical Research Site Tampa Florida
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 Tucson Arizona
United States Clinical Research Site Waukesha Wisconsin
United States Clinical Research Site West Jordan Utah
United States Clinical Research Site Wichita Kansas
United States Clinical Research Site Woodstock Vermont

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 Types and rates of adverse events up to 35 weeks
Primary Time from randomization to relapse of agitation symptoms up to 26 weeks
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