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

Axsome Therapeutics

Status and phase

Terminated

Phase 3

Conditions

Alzheimer Disease

Agitation, Psychomotor

Agitation in Patients With Dementia of the Alzheimer's Type

Treatments

Drug: AXS-05 (dextromethorphan-bupropion)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06736509

AXS-05-AD-305

Details and patient eligibility

About

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.

Full 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).

Enrollment

139 patients

Sex

All

Ages

65 to 90 years old

Volunteers

No Healthy Volunteers

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.