Clinical trial NCT04947553: A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
Official title: An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of AXS-05 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
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-01
Enrollment: 456
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 study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Long-term Safety
timeFrame: up to 76 weeks
measure: Time to relapse of agitation symptoms
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
measure: Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: up to 76 weeks
Locations:
city: Peoria
country: United States
facility: Clinical Research Site
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Site
state: Arizona
city: Long Beach
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: Walnut Creek
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: Coral Springs
country: United States
facility: Clinical Research Site
state: Florida
city: Greenacres City
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: Lake City
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: Trinity
country: United States
facility: Clinical Research Site
state: Florida
city: Columbus
country: United States
facility: Clinical Research Site
state: Georgia
city: Wichita
country: United States
facility: Clinical Research Site
state: Kansas
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: Chesterfield
country: United States
facility: Clinical Research Site
state: Missouri
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: Charlotte
country: United States
facility: Clinical Research Site
state: North Carolina
city: Hickory
country: United States
facility: Clinical Research Site
state: North Carolina
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: Sugar Land
country: United States
facility: Clinical Research Site
state: Texas
city: Arlington
country: United States
facility: Clinical Research Site
state: Virginia
city: Kelowna
country: Canada
facility: Clinical Research Site
state: British Columbia
city: San Juan
country: Puerto Rico
facility: Clinical Research Site
Study officials:
References: