A Phase 3, multicenter, randomized, double-blind, placebo-controlled 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
This important study is looking into a new medication called AVP-786. It's designed for people living with Alzheimer's disease who sometimes become agitated. Researchers want to find out if this medicine can help make these feelings of agitation less severe. They also want to understand if the medicine is safe and if people can take it without too many side effects. To do this, some participants will receive the actual medicine, while others will receive a placebo – a pill that looks the same but contains no active medicine. This allows researchers to compare the effects accurately. The study will measure changes in agitation over time to see how well the treatment works.
At a glance
What is this study about?
This study is about helping people with Alzheimer's disease who experience agitation. Agitation can mean someone feels restless, anxious, or distressed, and it can be challenging for both the person with dementia and their carers. Researchers are testing a new medicine called AVP-786 to see if it can help reduce these feelings.
Imagine a large group of people with Alzheimer's who experience agitation. Half of them will receive the new medicine, AVP-786, and the other half will receive a 'dummy' pill, called a placebo. Neither the patients nor their doctors will know who is getting which. This is done so everyone can be sure that any changes seen are truly due to the medicine and not just other factors.
The main goal is to measure how much agitation changes in people taking the medicine compared to those taking the dummy pill. They will use special ways to score agitation levels at the beginning and again at the end of the study. They also want to see if the medicine is safe and doesn't cause too many unwanted side effects. The results from this study will help doctors decide if AVP-786 could be a helpful treatment option in the future.
Key takeaways
- This study is testing a new medicine for agitation in Alzheimer's.
- It aims to see if AVP-786 is safe and effective.
- Participants will get either the new medicine or a dummy pill.
- The study helps advance understanding of Alzheimer's treatments.
- Your participation is voluntary and you can withdraw at any time.
Who may be eligible?
This study is looking for both men and women aged 18 or older. Participants must have been diagnosed with Alzheimer's disease and be experiencing agitation.
There might be other specific health requirements or medications that could prevent someone from joining. These details would be discussed with you by the study doctor to make sure the study is a good fit.
It's very important that you or your loved one meet all the study's requirements to ensure everyone's safety and to make sure the study results are reliable.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of Alzheimer's disease?
- Are you currently experiencing agitation?
- Are you able to attend regular study visits?
What does participation involve?
If you decide to take part, you would receive either the new study medication, AVP-786, or a placebo (a dummy pill). The study involves regular visits to the clinic where doctors and nurses will check your health, ask questions about your agitation levels, and monitor any side effects. You'll likely have physical exams and potentially some blood tests. The medication would need to be taken as directed. The study would last for a specific period, and after you stop taking the study medication, there might be follow-up visits to ensure your well-being. The total length of your involvement will be clearly explained by the study team.
Potential risks and benefits
Locations (7)
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Common questions
What is agitation?
Agitation in Alzheimer's disease can mean feeling restless, anxious, irritable, or distressed. It's often expressed through actions like pacing, fiddling, or shouting.
What is a placebo?
A placebo is a 'dummy' pill or treatment that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers compare the effects of the new medicine accurately.
What is AVP-786?
AVP-786 is the name of the new medicine being tested in this study. It's a combination of two ingredients: deudextromethorphan hydrobromide and quinidine sulfate, which work together.
Will I know if I'm getting the medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving the real medicine or the placebo. This is called 'double-blind' and is a standard way to get fair results.
How long will the study last?
The total length of the study for an individual will be explained by the research team. It usually involves a period of taking the medication and some follow-up visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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