Clinical trial NCT03226522: Addressing Dementia Via Agitation-Centered Evaluation
Official title: A Randomized, Double-blind, Placebo-controlled 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: PHASE2
PHASE3
Conditions: Agitation in Patients With Dementia of the Alzheimer's Type
Alzheimer Disease
Agitation,Psychomotor
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 366
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, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.


Eligibility criteria: Key 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.
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.

Primary outcomes:
measure: Change in CMAI Total Score
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Axsome Study Site
state: Arizona
city: Phoenix
country: United States
facility: Axsome Study Site
state: Arizona
city: Scottsdale
country: United States
facility: Axsome study site
state: Arizona
city: Scottsdale
country: United States
facility: Axsome study site
state: Arizona
city: Tucson
country: United States
facility: Axsome Study Site
state: Arizona
city: Little Rock
country: United States
facility: Axsome Study Site
state: Arkansas
city: Canoga Park
country: United States
facility: Axsome study site
state: California
city: Costa Mesa
country: United States
facility: Axsome study site
state: California
city: Fresno
country: United States
facility: Axsome study site
state: California
city: Long Beach
country: United States
facility: Axsome study site
state: California
city: Long Beach
country: United States
facility: Axsome study site
state: California
city: Los Alamitos
country: United States
facility: Axsome Study Site
state: California
city: Riverside
country: United States
facility: Axsome study site
state: California
city: Sacramento
country: United States
facility: Axsome study site
state: California
city: Santa Ana
country: United States
facility: Axsome study site
state: California
city: Santa Clarita
country: United States
facility: Axsome Study Site
state: California
city: Sherman Oaks
country: United States
facility: Axsome study site
state: California
city: Simi Valley
country: United States
facility: Axsome study site
state: California
city: Temecula
country: United States
facility: Axsome study site
state: California
city: Ventura
country: United States
facility: Axsome study site
state: California
city: Colorado Springs
country: United States
facility: Axsome Study Site
state: Colorado
city: Cromwell
country: United States
facility: Axsome study site
state: Connecticut
city: New London
country: United States
facility: Axsome study site
state: Connecticut
city: Apopka
country: United States
facility: Axsome Study Site
state: Florida
city: Boca Raton
country: United States
facility: Axsome study site
state: Florida
city: Boynton Beach
country: United States
facility: Axsome study site
state: Florida
city: Coconut Creek
country: United States
facility: Axsome Study Site
state: Florida
city: Greenacres City
country: United States
facility: Axsome Study Site
state: Florida
city: Hallandale Beach
country: United States
facility: Axsome study site
state: Florida
city: Hialeah
country: United States
facility: Axsome study site
state: Florida
city: Lake City
country: United States
facility: Axsome Study Site
state: Florida
city: Miami
country: United States
facility: Axsome study site
state: Florida
city: Miami
country: United States
facility: Axsome study site
state: Florida
city: Orlando
country: United States
facility: Axsome Study Site
state: Florida
city: Pensacola
country: United States
facility: Axsome study site
state: Florida
city: Port Orange
country: United States
facility: Axsome Study Site
state: Florida
city: Spring Hill
country: United States
facility: Axsome study site
state: Florida
city: Tampa
country: United States
facility: Axsome study site
state: Florida
city: Tampa
country: United States
facility: Axsome study site
state: Florida
city: Atlanta
country: United States
facility: Axsome study site
state: Georgia
city: Decatur
country: United States
facility: Axsome study site
state: Georgia
city: Honolulu
country: United States
facility: Axsome Study Site
state: Hawaii
city: Boise
country: United States
facility: Axsome study site
state: Idaho
city: Flossmoor
country: United States
facility: Axsome Study Site
state: Illinois
city: Avon
country: United States
facility: Axsome study site
state: Indiana
city: Overland Park
country: United States
facility: Axsome Study Site
state: Kansas
city: Topeka
country: United States
facility: Axsome Study Site
state: Kansas
city: Baton Rouge
country: United States
facility: Axsome study site
state: Louisiana
city: Lake Charles
country: United States
facility: Axsome Study Site
state: Louisiana
city: Hattiesburg
country: United States
facility: Axsome Study Site
state: Mississippi
city: Chesterfield
country: United States
facility: Axsome study site
state: Missouri
city: Saint Louis
country: United States
facility: Axsome Study Site
state: Missouri
city: Las Vegas
country: United States
facility: Axsome study site
state: Nevada
city: Las Vegas
country: United States
facility: Axsome Study Site
state: Nevada
city: Princeton
country: United States
facility: Axsome Study Site
state: New Jersey
city: Toms River
country: United States
facility: Axsome study site
state: New Jersey
city: Albany
country: United States
facility: Axsome Study Site
state: New York
city: Brooklyn
country: United States
facility: Axsome study site
state: New York
city: New York
country: United States
facility: Axsome study site
state: New York
city: New York
country: United States
facility: Axsome study site
state: New York
city: Staten Island
country: United States
facility: Axsome study site
state: New York
city: Charlotte
country: United States
facility: Axsome Study Site
state: North Carolina
city: Charlotte
country: United States
facility: Axsome study site
state: North Carolina
city: Winston-Salem
country: United States
facility: Axsome Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Axsome study site
state: Ohio
city: Dayton
country: United States
facility: Axsome Study Site
state: Ohio
city: Shaker Heights
country: United States
facility: Axsome study site
state: Ohio
city: Oklahoma City
country: United States
facility: Axsome Study Site
state: Oklahoma
city: DeSoto
country: United States
facility: Axsome study site
state: Texas
city: McKinney
country: United States
facility: Axsome Study Site
state: Texas
city: Wichita Falls
country: United States
facility: Axsome study site
state: Texas
city: Orem
country: United States
facility: Axsome study site
state: Utah
city: Charlottesville
country: United States
facility: Axsome Study Site
state: Virginia
city: Richmond
country: United States
facility: Axsome Study Site
state: Virginia
city: Bellevue
country: United States
facility: Axsome study site
state: Washington
city: Everett
country: United States
facility: Axsome Study Site
state: Washington
city: Spokane
country: United States
facility: Axsome study site
state: Washington
city: Caulfield
country: Australia
facility: Axsome study site
state: Melbourne, Victoria
Study officials:
References: