AXS-05 for Alzheimer's Disease Agitation

Recruiting at15 trial locations

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Axsome Therapeutics, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for individuals who have Alzheimer's disease with symptoms of agitation and participated in previous ADVANCE-2 or ACCORD-2 studies. It aims to understand the long-term safety of AXS-05, a medication intended to manage these symptoms.

Inclusion Criteria

Completed the treatment period in Study AXS-05-AD-304 or exited from Study AXS-05-AD-303 due to study completion

My caregiver agrees to follow the study's requirements and help me with my treatment.

Exclusion Criteria

I am currently living in a mental health facility, nursing home, or by myself.

Caregiver is unwilling or unable, in the opinion of the Investigator, to comply with study instructions

Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being

Treatment Details

Interventions

• AXS-05 (Other)

Trial Overview The study tests the ongoing safety of AXS-05 (a combination of dextromethorphan and bupropion) in managing agitation associated with Alzheimer's over an extended period. This open-label trial allows all participants to receive the drug.

Participant Groups

Group I: Open-Label Experimental Treatment 1 Intervention

Experimental: AXS-05 (dextromethorphan-bupropion) up to 25 weeks

Who Is Running the Clinical Trial?

Axsome Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

11,600+