Phase 3 of AVP-786 in Alzheimer’s dementia patients with agitation
Research type
Research Study
Full title
A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-design study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/ quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer’s type.
IRAS ID
229419
Contact name
Dag Aarsland
Contact email
Sponsor organisation
Avanir Pharmaceuticals Inc.
Eudract number
2017-001339-38
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
124099, IND
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Summary of Research
This is a research study to test a new investigational medicine called AVP-786 in participants with probable Alzheimer’s Disease (AD) who have agitation. AD causes loss of brain cells and problems with memory, thinking and behaviour. Agitated behaviours such as irritability and restlessness, physical and verbal aggression, and pacing and wandering are major problems, can be difficult to manage, and can impact quality of life of patients. Currently, there are no medications approved in the UK to treat agitation in patients with AD. In the United Kingdom (UK), approximately 850,000 people suffer from dementia of which AD accounts for approximately 62% of the cases.The purpose of this study is to see if AVP-786 is effective and safe in treating agitation in participants with Alzheimer’s Disease. Around 412 participants in approximately 70 study centres globally will participate in this study. Participants will be enrolled in the study for approximately 16 weeks; with up to a 4-week screening period and a 12-week treatment period. The study will be conducted at hospitals identified as research sites. This study will include 8 visits to the research site and two phone calls from the study doctor to see how participants are managing on the study medicine.
AVP-786 is a combination of two medicines; one medicine is called deudextromethorphan hydrobromide (d6-DM) and the other is quinidine sulphate (Q), given in a very low dose. The study will also include a placebo. A placebo is an investigational medicine look-alike, but is not a medicine and contains no active ingredient. Eligible participants will be randomised into the study and will have a 60% chance of receiving AVP-786 study medication and 40% chance of receiving placebo.
Summary of Results
Agitation is a common feature of Alzheimer's disease and dementia and is estimated to affect 80% of patients with dementia. Agitation is associated with a decreased quality of life and increased caregiver burden.This study was conducted determine if AVP-786 would be a safe, effective medication compared to placebo (a dummy medication) to treat moderate to severe agitation in participants with Alzheimer's Disease. This is a multicenter, randomised, double-blind study, consisting of 12 weeks of treatment.
Approximately 601 participants were enrolled at approximately 212 centers worldwide. Study medication was administered orally twice a day, from Day 1 through Day 85.At week 12, there were no significant changes between AVP-786 and placebo in treating agitation in Alzheimer's Disease Participants on this study. In addition, there was a greater incidence of patient falls when taking AVP-786, and falls were classified as a risk when taking the medication. Due to these results and a review of all previously completed studies, Otsuka decided to terminate future development of the AVP-786 compound. The last participant last visit (LPLV) took place in the USA on 14-Dec-2023; the date which defines global End of Trial.
REC name
Wales REC 2
REC reference
18/WA/0088
Date of REC Opinion
24 Apr 2018
REC opinion
Further Information Favourable Opinion