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AXS-05 for Alzheimer's Disease Agitation

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
Initiation of a new medication since enrolling in AXS-05-AD-302 which may pose a safety risk when taken concurrently with AXS-05.
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 76 weeks
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new drug for Alzheimer's patients who experience agitation. The goal is to see if it is safe and effective long-term.

Who is the study for?
This trial is for individuals with Alzheimer's disease who experience agitation and have a caregiver willing to oversee treatment. Participants must have been in prior AXS-05 studies (AXS-05-AD-302 or AXS-05-AD-304). Excluded are those in mental health facilities, nursing homes, living alone, or with conditions that could affect the study or pose risks.
What is being tested?
The trial is testing the long-term safety and effectiveness of a medication called AXS-05 designed to treat agitation in Alzheimer's patients. It's an open-label study where everyone receives the drug and their responses are monitored over time.
What are the potential side effects?
While specific side effects aren't listed here, common ones for medications like AXS-05 may include nausea, dizziness, sleep disturbances, mood changes, and potential interactions with other drugs.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I started a new medication after joining the AXS-05 study that might not be safe to take with AXS-05.
Select...
I am currently in a mental health facility, nursing home, or living alone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 76 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 76 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
Other study objectives
Cohen-Mansfield Agitation Inventory (CMAI)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AXS-05 (dextromethorphan-bupropion)Experimental Treatment1 Intervention
* Up to 52 weeks in the open-label segment; * Up to 24 weeks in the randomized double-blind segment (if applicable)
Group II: PlaceboPlacebo Group1 Intervention
Up to 24 weeks in the randomized double-blind segment (if applicable)
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

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
31 Previous Clinical Trials
10,627 Total Patients Enrolled
~0 spots leftby Dec 2024
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