NCT06736509

An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this open-label extension trial is to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 and ACCORD-2.

Detailed description

This is a multi-center, open-label extension trial to evaluate the long-term safety of AXS-05 in subjects with Alzheimer's disease (AD) agitation that wish to continue to receive AXS-05 given completion of ADVANCE-2 (AXS-05-AD-304) and ACCORD-2 (AXS-05-AD-303).

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

Timeline

• Start date: 2024-11-21
• Primary completion: 2025-02-17
• Completion: 2025-04-25
• First posted: 2024-12-16
• Last updated: 2026-02-19

Locations

22 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study