A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation (ADVANCE-2)

Axsome Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Alzheimer Disease; Agitation; Agitation in Patients With Dementia of the Alzheimer's Type

Treatments: Drug: AXS-05; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05557409

AXS-05-AD-304

Details and patient eligibility

About

This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.

Full description

Eligible subjects will be randomized in a 1:1 ratio for up to 5 weeks to be treated with AXS-05 or placebo.

Enrollment: 350 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

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 significant 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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350 participants in 2 patient groups, including a placebo group

AXS-05

Experimental group

Description:

Up to 5 weeks

Treatment:

Drug: AXS-05

Placebo

Placebo Comparator group

Description:

Up to 5 weeks

Treatment:

Drug: Placebo