NCT04797715

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Enrolled patients will first enter a 9-week, open-label stabilization period, during which they will be treated with AXS-05 and monitored for a treatment response. Patients who experience a treatment response during the stabilization period will then be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs.

Conditions

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

Interventions

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

Timeline

• Start date: 2020-12-31
• Primary completion: 2022-11-21
• Completion: 2022-11-21
• First posted: 2021-03-15
• Last updated: 2023-11-29

Locations

63 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study