NCT04947553

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

An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Dementia of the Alzheimer's Type

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.

Detailed description

This study is a multi-center trial consisting of an open-label segment of up to 52 weeks, followed by a double-blind, placebo-controlled, randomized withdrawal segment. Subjects participating in the randomized-withdrawal segment will be randomized in a 1:1 ratio either to continue to receive AXS-05 or switch to placebo, for up to 24 weeks.

Conditions

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

Interventions

Type	Name	Description
DRUG	AXS-05 (dextromethorphan-bupropion)	AXS-05 tablets, taken twice daily
DRUG	Placebo	Placebo tablets, taken twice daily

Timeline

• Start date: 2021-06-17
• Primary completion: 2024-12-03
• Completion: 2024-12-21
• First posted: 2021-07-01
• Last updated: 2025-12-08

Locations

47 sites across 3 countries: United States, Canada, Puerto Rico

Regulatory

• FDA-regulated drug study