NCT05557409

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Agitation in Patients With Dementia of the Alzheimer's Type
• Alzheimer Disease
• Agitation

Interventions

Type	Name	Description
DRUG	AXS-05	AXS-05 tablets, taken twice daily
DRUG	Placebo	Placebo tablets, taken twice daily

Timeline

• Start date: 2022-09-06
• Primary completion: 2024-11-21
• Completion: 2024-12-21
• First posted: 2022-09-28
• Last updated: 2025-11-26

Locations

55 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study