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 tests a new treatment called AVP-786 to determine its effectiveness in reducing agitation in people with Alzheimer's disease. Researchers aim to assess whether AVP-786 is safe and effective compared to a placebo (a pill with no active medicine). Participants will take capsules twice a day for 12 weeks. The trial seeks individuals diagnosed with Alzheimer's who have experienced moderate to severe agitation disrupting their daily lives for at least two weeks. Participants need a caregiver to assist with study tasks and medication routines. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it mentions that you should not take any prohibited medications during the study. It's best to discuss your current medications with the study team to see if any adjustments are needed.
Is there any evidence suggesting that AVP-786 is likely to be safe for humans?
Research has shown that AVP-786 has been tested in people with Alzheimer's disease to treat agitation. Some patients tolerate it well, but side effects have occurred. For instance, one study found that people taking AVP-786 experienced more falls than those on a placebo. Specifically, 8.6% of patients in the high-dose group and 9.1% in the low-dose group experienced falls.
Despite these side effects, earlier trials generally suggest that many patients tolerate AVP-786 well. This treatment is still under study to better understand its safety and effectiveness. While there are positive signs, some risks remain.12345Why do researchers think this study treatment might be promising for Alzheimer's?
AVP-786 is unique because it combines dextromethorphan and quinidine, aiming to reduce agitation in Alzheimer's patients. Unlike standard treatments that often focus on neurotransmitters like acetylcholine or glutamate, AVP-786 works differently by modulating the sigma-1 and NMDA receptors. Researchers are excited about this treatment because it offers a novel approach that could improve symptoms with potentially fewer side effects compared to current options.
What evidence suggests that AVP-786 might be an effective treatment for agitation in Alzheimer's disease?
In this trial, participants will receive either AVP-786 or a placebo. Research has shown that AVP-786 has been studied for treating restlessness in people with Alzheimer's. One study found that AVP-786 helped reduce restlessness and was safe for over 200 patients. However, another study found it did not outperform a placebo. While there is some hope, further research is needed to confirm its effectiveness for restlessness in Alzheimer's disease.12456
Are You a Good Fit for This Trial?
This trial is for people with Alzheimer's who've had moderate-to-severe agitation for at least 2 weeks, affecting daily life. They need a reliable caregiver and must have tried non-drug therapies first. It's not for those with other types of dementia or agitation due to another condition, nor for those with serious health issues like uncontrolled diabetes or heart disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either AVP-786 or placebo capsules administered twice daily for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AVP-786
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Avanir Pharmaceuticals
Lead Sponsor
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