Clinical trial NCT06736509: An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study
Official title: An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
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: 2024-12-16
Enrollment: 139
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this open-label extension trial is to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 and ACCORD-2.

Detailed description: This is a multi-center, open-label extension trial to evaluate the long-term safety of AXS-05 in subjects with Alzheimer's disease (AD) agitation that wish to continue to receive AXS-05 given completion of ADVANCE-2 (AXS-05-AD-304) and ACCORD-2 (AXS-05-AD-303).

Eligibility criteria: Inclusion Criteria:

* Completed the treatment period in Study AXS-05-AD-304 or exited from Study AXS-05-AD-303 due to study completion.
* 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-304 and/or AXS-05-AD-303 which may pose a safety risk when taken concurrently with AXS-05.

Primary outcomes:
measure: Long-Term Safety
timeFrame: Up to 25 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Clinical Research Site
state: Arizona
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: Green Acres
country: United States
facility: Clinical Research Site
state: Florida
city: Hialeah
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: 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: Braintree
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Brooklyn
country: United States
facility: Clinical Research Site
state: New York
city: Charlotte
country: United States
facility: Clinical Research Site
state: North Carolina
city: Mesquite
country: United States
facility: Clinical Research Site
state: Texas
city: Arlington
country: United States
facility: Clinical Research Site
state: Virginia
city: San Juan
country: Puerto Rico
facility: Clinical Research Site
Study officials:
References: