Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

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 experience agitation. Agitation is a common and challenging symptom of Alzheimer's, and this research hopes to find a new way to help. The study is comparing AVP-786 with a 'dummy pill' (placebo) to see if the new medicine is effective at reducing these symptoms. Researchers will also be carefully checking for any side effects, meaning they want to make sure it's safe and well-tolerated. This is a large-scale study, meaning it involves many people and is a crucial step before any new medicine can become widely available. Participants are randomly assigned to receive either the active medicine or the placebo, and neither they nor their doctors will know who is receiving which, to ensure fair and accurate results.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Otsuka Pharmaceutical Development & Commercialization Inc.

Enrolment target

248

Start

25 Apr 2024

Agitation in Patients With Dementia of the Alzheimer's Type

What is this study about?

This study is an important step in finding new ways to help people living with Alzheimer's disease, especially those who experience agitation. Agitation can be a distressing symptom for both the person with Alzheimer's and their caregivers. It can involve restlessness, pacing, shouting, or general unease. The researchers are testing a new medicine called AVP-786 to see if it can safely and effectively reduce these symptoms.

The study is designed to be very thorough. Some people will receive the new medicine AVP-786, while others will receive a 'dummy pill' called a placebo. This is a standard way to test new medicines, as it allows researchers to compare the effects of the actual drug against no active treatment. Neither the participants nor their doctors will know who is receiving which, to make sure everyone is assessed fairly and without bias. The main goal is to measure how much (if at all) agitation symptoms improve for those taking the new medicine.

Researchers will also be closely monitoring the safety of AVP-786, looking out for any unwanted side effects. If the new medicine proves to be both effective and safe, it could offer a hopeful new option for managing agitation in people with Alzheimer's disease. This type of research is vital for advancing our understanding and treatment of neurological conditions like Alzheimer's.

Key takeaways

This study is testing a new medicine (AVP-786) for agitation in Alzheimer's disease.
It aims to find out if the medicine is safe and effective.
Participants will receive either the new medicine or a dummy pill (placebo).
Close medical monitoring and assessments will be part of taking part.
The study includes adults aged 18 and over, with Alzheimer's and agitation.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, you would need to be an adult, 18 years old or older, with a diagnosis of Alzheimer's disease. Both men and women are welcome to take part.

While the exact details are not listed here, generally, studies like this look for specific health conditions, such as the stage of Alzheimer's and how severe the agitation symptoms are. They might also consider other medications you are currently taking or other health problems you have, to make sure the study is right for you and safe.

The research team will carry out a full health check and ask detailed questions about your medical history to ensure you meet all the requirements for taking part. This is to protect your safety and to make sure the study results are as clear and accurate as possible.

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?
Do you experience symptoms of agitation related to your Alzheimer's?
Are you able to attend regular study appointments?
Are you willing to take the study medication as prescribed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be involved in several visits to the clinic over a period of time. You would receive either the new study medicine (AVP-786) or a 'dummy pill' (placebo), which looks exactly the same as the active medicine. You would take this medication as prescribed by the study doctors.

During your visits, the research team would assess your agitation symptoms, likely using special questionnaires or scales. They would also monitor your overall health and well-being very closely for any side effects. This might involve physical examinations, blood tests, and other health checks. There would be regular check-ups to see how you are doing and how the medication is affecting you. The total length of time you would be involved in the study would be explained to you in detail by the research team.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as receiving a new investigational treatment for agitation that is not yet widely available, and having very close medical supervision. However, there are also potential risks, as with any new medicine. You might experience side effects from the study medication, though these would be carefully monitored. There's also a chance the new treatment might not work for you, or you could receive the placebo. Your participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Slovenia
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Unverified
Hungary
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Unverified
Belgium
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Unverified
Slovakia
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Unverified
Netherlands
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Unverified
Ireland
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Unverified
Croatia

Common questions

What is agitation in Alzheimer's disease?

Agitation means feeling restless, distressed, or showing behaviours like pacing, shouting, or being easily upset, often seen in people with Alzheimer's disease.

What is AVP-786?

AVP-786 is a new medicine being tested to see if it can help reduce agitation symptoms in people with Alzheimer's disease.

What is a 'dummy pill' or placebo?

A dummy pill (placebo) looks like the actual medicine but doesn't contain any active ingredients. It's used to compare against the real medicine.

Will I know if I'm getting the real medicine or the dummy pill?

No, neither you nor your study doctor will know whether you are receiving the real medicine or the dummy pill. This is standard practice in research.

Is this medicine available to everyone now?

No, AVP-786 is still in the testing phase and is not yet available to the general public. This study is part of the process to find out if it should be.