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AXS-05 for Alzheimer's Disease Agitation

Peoria, AZ
Phase 3
Waitlist Available
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Must not have
Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 25 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will assess the safety of AXS-05 over a long period for treating agitation in Alzheimer's patients who were in two previous studies.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include nausea, dizziness, insomnia, dry mouth, constipation, and possible increase in blood pressure due to bupropion component. Long-term effects are being studied.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently living in a mental health facility, nursing home, or by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 25 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Long-Term Safety

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-LabelExperimental Treatment1 Intervention
Experimental: AXS-05 (dextromethorphan-bupropion) up to 25 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXS-05 (dextromethorphan-bupropion)
2020
Completed Phase 2
~190

Find a Location

Closest Location:Clinical Research Site· Peoria, AZ

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
32 Previous Clinical Trials
10,905 Total Patients Enrolled
~100 spots leftby Aug 2025