AXS-05 for Alzheimer's Disease Agitation

(ADVANCE-2 Trial)

Recruiting at 55 trial locations

Overseen By Study Director

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Axsome Therapeutics, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called AXS-05 to see if it can help reduce agitation in people with Alzheimer's disease. The goal is to find out if AXS-05 can balance brain chemicals to calm agitation and improve behavior. AXS-05, a combination of dextromethorphan and bupropion, is being investigated for its potential to treat agitation in Alzheimer's disease and has shown promise in early clinical trials.

Eligibility Criteria

This trial is for people with Alzheimer's disease who are experiencing significant agitation. Participants must be diagnosed based on specific criteria and able to follow the study procedures. Those with non-Alzheimer's dementia or deemed medically unfit by the investigator cannot join.

Inclusion Criteria

I have been diagnosed with significant agitation due to Alzheimer's disease.

Exclusion Criteria

You have a type of dementia that is not mainly caused by Alzheimer's disease.

Treatment Details

Interventions

• AXS-05 (NMDA receptor antagonist)
• Placebo (Drug)

Trial Overview The trial is testing AXS-05 against a placebo to see if it can safely reduce agitation in Alzheimer's patients. It involves multiple centers, where participants are randomly assigned to receive either the real drug or a placebo without knowing which one they're getting.

Participant Groups

Group I: AXS-05 Experimental Treatment 1 Intervention

Up to 5 weeks

Group II: Placebo Placebo Group 1 Intervention

Up to 5 weeks

Who Is Running the Clinical Trial?

Axsome Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

11,600+