AVP-786 for Agitation in Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a medication called AVP-786 on individuals who have taken part in previous studies. The goal is to see if this medication can help with their conditions over time.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used NUEDEXTA® in the 2 weeks before starting the trial.
Is AVP-786 safe for humans?
How is the drug AVP-786 different from other treatments for agitation in Alzheimer's disease?
AVP-786 is unique because it combines deuterated dextromethorphan with quinidine, which helps the drug stay in the body longer and penetrate the brain more effectively. Unlike other treatments, it has been granted fast-track designation by the FDA, indicating its potential as a promising new option for managing agitation in Alzheimer's disease.12367
What data supports the effectiveness of the drug AVP-786 for agitation in Alzheimer's disease?
Are You a Good Fit for This Trial?
This trial is for patients with Alzheimer's-related dementia who've completed certain earlier studies (15-AVP-786-301, 302, 12-AVR-131, or 17-AVP-786-305). They should be experiencing moderate to severe agitation and have a specific level of cognitive function. It's open to out-patients or those in assisted living/nursing homes but not for individuals at high risk of falls or with other serious health issues that could affect safety results.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AVP-786 capsules twice a day over a 52-week period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to receive AVP-786 in a long-term extension study
What Are the Treatments Tested in This Trial?
Interventions
- AVP-786
Find a Clinic Near You
Who Is Running the Clinical Trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead Sponsor
John Kraus
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Medical Officer since 2023
MD, PhD
Tarek Rabah
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Executive Officer since 2022
BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University
Avanir Pharmaceuticals
Lead Sponsor