AXS-05 for Alzheimer's Disease Agitation
(ADVANCE-2 Trial)

Recruiting in Palo Alto (17 mi)

+55 other locations

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.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AXS-05Experimental Treatment1 Intervention

Up to 5 weeks

Group II: PlaceboPlacebo Group1 Intervention

Up to 5 weeks

AXS-05 is already approved in United States for the following indications:

🇺🇸 Approved in United States as Auvelity for: