Clinical trial NCT05557409: A Study to Assess the Efficacy and Safety of AXS-05 in Subjects with Alzheimer's Disease Agitation
Official title: ADVANCE-2: Addressing Dementia Via Agitation-Centered Evaluation 2: a Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer's Disease Agitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Agitation in Patients with Dementia of the Alzheimer's Type
Alzheimer Disease
Agitation
Keywords: AD agitation
AXS-05
NMDA receptor antagonist
dextromethorphan
bupropion
Axsome
ADVANCE-2
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-28
Enrollment: 408
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 trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.

Detailed description: Eligible subjects will be randomized in a 1:1 ratio for up to 5 weeks to be treated with AXS-05 or placebo.

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 significant 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.
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.

Primary outcomes:
measure: Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: Up to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Clinical Research Site
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Site
state: Arizona
city: Tucson
country: United States
facility: Clinical Research Site
state: Arizona
city: Canoga Park
country: United States
facility: Clinical Research Site
state: California
city: Long Beach
country: United States
facility: Clinical Research Site
state: California
city: Los Alamitos
country: United States
facility: Clinical Research Site
state: California
city: Walnut Creek
country: United States
facility: Clinical Research Site
state: California
city: West Covina
country: United States
facility: Clinical Research Site
state: California
city: Bonita Springs
country: United States
facility: Clinical Research Site
state: Florida
city: Brandon
country: United States
facility: Clinical Research Site
state: Florida
city: Green Acres
country: United States
facility: Clinical Research Site
state: Florida
city: Hialeah
country: United States
facility: Clinical Research Site
state: Florida
city: Hollywood
country: United States
facility: Clinical Research Site
state: Florida
city: Kissimmee
country: United States
facility: Clinical Research Site
state: Florida
city: Miami Gardens
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: 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: Miami
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: Tampa
country: United States
facility: Clinical Research Site
state: Florida
city: Tampa
country: United States
facility: Clinical Research Site
state: Florida
city: Augusta
country: United States
facility: Clinical Research Site
state: Georgia
city: College Park
country: United States
facility: Clinical Research Site
state: Georgia
city: Columbus
country: United States
facility: Clinical Research Site
state: Georgia
city: Wichita
country: United States
facility: Clinical Research Site
state: Kansas
city: Marrero
country: United States
facility: Clinical Research Site
state: Louisiana
city: Braintree
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Flint
country: United States
facility: Clinical Research Site
state: Michigan
city: Rochester Hills
country: United States
facility: Clinical Research Site
state: Michigan
city: Troy
country: United States
facility: Clinical Research Site
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Site
state: Missouri
city: Berlin
country: United States
facility: Clinical Research Site
state: New Jersey
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: New Windsor
country: United States
facility: Clinical Research Site
state: New York
city: Staten Island
country: United States
facility: Clinical Research Site
state: New York
city: Woodmere
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: Middleburg Heights
country: United States
facility: Clinical Research Site
state: Ohio
city: Austin
country: United States
facility: Clinical Research Site
state: Texas
city: Cypress
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: Sugarland
country: United States
facility: Clinical Research Site
state: Texas
city: Rutland
country: United States
facility: Clinical Research Site
state: Vermont
city: Arlington
country: United States
facility: Clinical Research Site
state: Virginia
city: Bayamon
country: Puerto Rico
facility: Clinical Research Site
city: San Juan
country: Puerto Rico
facility: Clinical Research Site
Study officials:
References: