ADVANCE-2: Addressing Dementia Via Agitation-Centered Evaluation 2: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer's Disease Agitation

Axsome Therapeutics, Inc.1 site in 1 country408 target enrollmentSeptember 6, 2022

InterventionsAXS-05 Placebo

DrugsAXS-05 Placebo

Overview

Phase: Phase 3
Intervention: AXS-05
Conditions: Not specified
Sponsor: Axsome Therapeutics, Inc.
Enrollment: 408
Locations: 1
Primary Endpoint: Cohen-Mansfield Agitation Inventory (CMAI)
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

September 6, 2022

End Date

December 21, 2024

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Axsome Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.