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

Phase 3

Completed

• Conditions: Agitation in Patients with Dementia of the Alzheimer's Type; Alzheimer Disease; Agitation
• Interventions: Drug: AXS-05; Drug: Placebo

• Registration Number: NCT05557409
• Lead Sponsor: Axsome Therapeutics, Inc.

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.

Study Timeline

• Study Start: 2022-09-06
• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Primary Completion: 2024-11-21
• Study Completion: 2024-12-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXS-05	AXS-05	Up to 5 weeks
Placebo	Placebo	Up to 5 weeks

Primary Outcome Measures

Name	Time	Method
Cohen-Mansfield Agitation Inventory (CMAI)	Up to 5 weeks

Trial Locations

Locations (1)

Clinical Research Site; 🇵🇷 San Juan, Puerto Rico