Clinical trial NCT04797715: Assessing Clinical Outcomes in Alzheimer's Disease Agitation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
ACCORD
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-15
Enrollment: 178
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time from randomization to relapse of agitation symptoms
timeFrame: up to 26 weeks
Secondary outcomes:
Other outcomes:
measure: Types and rates of adverse events
timeFrame: up to 35 weeks
Locations:
city: Sun City
country: United States
facility: Clinical Research Site
state: Arizona
city: Tucson
country: United States
facility: Clinical Research Site
state: Arizona
city: Chula Vista
country: United States
facility: Clinical Research Site
state: California
city: Imperial
country: United States
facility: Clinical Research Site
state: California
city: Lafayette
country: United States
facility: Clinical Research Site
state: California
city: Los Alamitos
country: United States
facility: Clinical Research Site
state: California
city: Los Angeles
country: United States
facility: Clinical Research Site
state: California
city: Oceanside
country: United States
facility: Clinical Research Site
state: California
city: San Diego
country: United States
facility: Clinical Research Site
state: California
city: Santa Ana
country: United States
facility: Clinical Research Site
state: California
city: Temecula
country: United States
facility: Clinical Research Site
state: California
city: Coral Springs
country: United States
facility: Clinical Research Site
state: Florida
city: Hialeah
country: United States
facility: Clinical Research Site
state: Florida
city: Kissimmee
country: United States
facility: Clinical Research Site
state: Florida
city: Lake City
country: United States
facility: Clinical Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Clinical Research Site
state: Florida
city: Miami
country: United States
facility: Clinical Research Site
state: Florida
city: Miami
country: United States
facility: Clinical Research Site
state: Florida
city: Miami
country: United States
facility: Clinical Research Site
state: Florida
city: Naples
country: United States
facility: Clinical Research Site
state: Florida
city: Ocoee
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Clinical Research Site
state: Florida
city: Pensacola
country: United States
facility: Clinical Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Clinical Research Site
state: Florida
city: Sunrise
country: United States
facility: Clinical Research Site
state: Florida
city: Tampa
country: United States
facility: Clinical Research Site
state: Florida
city: Trinity
country: United States
facility: Clinical Research Site
state: Florida
city: Augusta
country: United States
facility: Clinical Research Site
state: Georgia
city: Columbus
country: United States
facility: Clinical Research Site
state: Georgia
city: Suwanee
country: United States
facility: Clinical Research Site
state: Georgia
city: Honolulu
country: United States
facility: Clinical Research Site
state: Hawaii
city: Boise
country: United States
facility: Clinical Research Site
state: Idaho
city: Wichita
country: United States
facility: Clinical Research Site
state: Kansas
city: Bangor
country: United States
facility: Clinical Research Site
state: Maine
city: Lowell
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Flint
country: United States
facility: Clinical Research Site
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Site
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Site
state: Nevada
city: Toms River
country: United States
facility: Clinical Research Site
state: New Jersey
city: Brooklyn
country: United States
facility: Clinical Research Site
state: New York
city: East Syracuse
country: United States
facility: Clinical Research Site
state: New York
city: New Windsor
country: United States
facility: Clinical Research Site
state: New York
city: New York
country: United States
facility: Clinical Research Site
state: New York
city: Charlotte
country: United States
facility: Clinical Research Site
state: North Carolina
city: Hickory
country: United States
facility: Clinical Research Site
state: North Carolina
city: Dayton
country: United States
facility: Clinical Research Site
state: Ohio
city: Jenkintown
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Austin
country: United States
facility: Clinical Research Site
state: Texas
city: Cypress
country: United States
facility: Clinical Research Site
state: Texas
city: Houston
country: United States
facility: Clinical Research Site
state: Texas
city: McKinney
country: United States
facility: Clinical Research Site
state: Texas
city: Mesquite
country: United States
facility: Clinical Research Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Research Site
state: Texas
city: Sugar Land
country: United States
facility: Clinical Research Site
state: Texas
city: West Jordan
country: United States
facility: Clinical Research Site
state: Utah
city: Woodstock
country: United States
facility: Clinical Research Site
state: Vermont
city: Everett
country: United States
facility: Clinical Research Site
state: Washington
city: Waukesha
country: United States
facility: Clinical Research Site
state: Wisconsin
city: Kelowna
country: Canada
facility: Clinical Research Site
state: British Columbia
city: Newmarket
country: Canada
facility: Clinical Research Site
state: Ontario
Study officials:
References: