A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

Axsome Therapeutics

Status and phase

Invitation-only

Phase 3

Conditions

Alzheimer Disease

Agitation, Psychomotor

Agitation in Patients With Dementia of the Alzheimer's Type

Treatments

Drug: AXS-05 (dextromethorphan-bupropion)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04947553

AXS-05-AD-303

Details and patient eligibility

About

This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

65 to 90 years old

Volunteers

No Healthy Volunteers

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.