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AXS-05 (dextromethorphan-bupropion) for Agitation in Dementia

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 76 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Long-term Safety
Time to relapse of agitation symptoms
Other outcome measures
Cohen-Mansfield Agitation Inventory (CMAI)

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
27 Previous Clinical Trials
7,592 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who does this research project require as participants?

"The prerequisites for enrolling in this clinical trial are a diagnosis of Alzheimer's disease and being between ages 65-90. So far, they have recruited 260 patients."

Answered by AI

What patients does AXS-05 (dextromethorphan-bupropion) typically help?

"AXS-05 (dextromethorphan-bupropion) is an effective treatment for catarrh, attention deficit hyperactivity disorder (ADHD), and rhinorrhoea."

Answered by AI

At how many hospitals or research centers is this drug trial being conducted?

"There are 25 different centres running this trial, with locations in Flint, McKinney, Temecula and 22 other places. If you enroll in the study, you will be assigned to a location close to you to minimize travel burden."

Answered by AI

Are there any other investigations that have been done with AXS-05 (dextromethorphan-bupropion)?

"Dextromethorphan-bupropion, or AXS-05, is being trialled in 44 separate clinical studies. Of these, 15 are in Phase 3. New Haven, Connecticut is hosting the majority of these trials, however there are 301 total locations across the United States."

Answered by AI

Does this research require that subjects be under a certain age?

"The age requirement for this study is that participants must be between 65 and 90 years old."

Answered by AI

Are there any current vacancies in this clinical trial for willing participants?

"According to the information available on clinicaltrials.gov, this study is not recruiting patients at the moment. The trial was originally posted on 6/17/2021 and was most recently updated on 9/29/2022. There are, however, 838 other trials that are actively looking for participants."

Answered by AI

Are there any dangers associated with taking AXS-05 (dextromethorphan-bupropion)?

"AXS-05 (dextromethorphan-bupropion) received a score of 3 for safety. This is due to the fact that this medication is currently in Phase 3 trials, meaning that there is both efficacy and safety data available."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
How old are they?
18 - 65
What site did they apply to?
Clinical Research Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Sick of being suck. Lost my friends, family and myself.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
2021. "A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04947553.
All > Alzheimer Disease > Wellbutrin
~51 spots leftby Dec 2024
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