RecruitingNAINTERVENTIONAL

Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease

This study aims to understand if there's a connection between sleep problems and the early stages of Alzheimer's disease. Alzheimer's causes memory loss and thinking difficulties, partly due to a build-up of certain proteins (beta-amyloid) in the brain. Scientists wonder if this build-up affects sleep, or if poor sleep makes the build-up worse. The study will involve people aged 50-85 who are at higher risk of developing Alzheimer's, possibly due to their genes. They will look closely at participants' sleep using overnight tests, assess their thinking skills, and ask questions about their sleep and daily behaviour. If a clear link is found, it could mean that treating sleep problems might become an early way to help manage or even slow down the progression of Alzheimer's disease in the future.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Montpellier

Enrolment target

Start

05 Feb 2025

Estimated completion

01 Dec 2027

Neuropathology Cognitive Decline Sleep Disorder

What is this study about?

This research study is trying to understand the early stages of Alzheimer's disease. Alzheimer's is a condition that gradually affects memory and thinking. We know that in the very early stages, a specific protein called beta-amyloid starts to build up in the brain. Researchers have noticed that people developing Alzheimer's often have sleep problems, and they think there might be a connection between this protein build-up and disrupted sleep, but they need more evidence.

The main goal of this study is to see if there's a strong link between having sleep difficulties and experiencing early signs of memory or thinking decline. If scientists can prove this connection, it could be a very important discovery. It might suggest that by identifying and treating sleep problems early on, we could potentially help slow down the progress of Alzheimer's disease in some people.

The study focuses on individuals who are considered to be at a higher risk of developing Alzheimer's. This might include people who have a certain gene marker, called APOE ε4. Having one or two copies of this gene can increase your chances of developing Alzheimer's, often at an earlier age. By studying these individuals, researchers hope to get a clearer picture of how sleep, brain changes, and thinking skills are related in the very early stages of the disease.

Key takeaways

This study explores the link between sleep problems and early Alzheimer's.
It aims to see if treating sleep issues could help slow the disease.
Participants will have sleep tests, memory assessments, and fill out questionnaires.
The study includes people aged 50-85 with mild Alzheimer's or at higher risk.
A family carer is needed to assist with some parts of the study.
This research focuses on understanding the disease, not offering new treatments.

Who may be eligible?

This study is looking for volunteers between the ages of 50 and 85.

To be considered for this study, you would need to have an early, mild diagnosis of Alzheimer's disease and your memory and thinking scores (measured by a test called MMS) should be between 21 and 30. You also can't be on certain medications for Alzheimer's (like anticholinesterase or memantine) unless you've been on a steady dose for at least three months. If you take antidepressants or anxiety medication, you would need to have stopped them for at least 15 days before joining. It's also important to have a family member or carer who can help you with some of the study's questionnaires and diaries, and you must be part of the French social security system.

However, there are reasons why you might not be able to join. For example, if your Alzheimer's is caused by a specific gene, if you live in a care home, or if health problems might make it hard to do the tests. People who are unable to read or write, or have severe depression, or other serious health conditions that could be life-threatening in the short term, would also not be able to take part. Also, if you are protected by certain laws or deprived of liberty, you can't join this study.

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 between 50 and 85 years old?
Do you have a mild diagnosis of Alzheimer's with an MMS score between 21 and 30?
Do you have a family member or carer who can help you with study tasks?
Are you part of the French social security system?
Are you currently not taking certain Alzheimer's medications, or have been on a stable dose for at least 3 months?
Do you not have other serious health problems that would prevent you from doing the tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several assessments. These will include overnight sleep tests (polysomnography) to accurately measure your sleep patterns. You'll also do various memory and thinking tests (neuropsychological assessments) and fill out questionnaires about your sleep and any behaviour changes. You might also wear a small device (actimeter) to track your activity and sleep, and have blood tests to look for certain markers in your body.

Having a family carer or close family member is important, as they will be asked to help complete some of the questionnaires and sleep diaries. The study team will explain all the procedures in detail and ensure you're able to complete all the necessary visits and follow the study instructions. The total duration of your involvement in the study is not specified in the summary, but it would involve multiple visits and assessments. You will be able to discuss the full schedule with the study team.

Potential risks and benefits

Taking part in a study like this helps researchers learn more about Alzheimer's disease, which could benefit many people in the future. You might also gain a better understanding of your own sleep patterns and thinking abilities. However, there are some potential risks. These could include discomfort from the sleep monitoring equipment, time commitment for visits and tests, and the emotional impact of undergoing memory assessments. All procedures will be explained thoroughly, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CHU de Montpellier
Verified postcode
Montpellier, France· Recruiting

Common questions

What is Alzheimer's disease?

It's a condition that gradually causes problems with memory, thinking, and behaviour, getting worse over time.

What does 'at risk' mean in this study?

It means the study is looking at people who have certain factors, like specific genes, that might make them more likely to develop Alzheimer's later on.

Will this study give me a new treatment?

No, this study is primarily about understanding the connection between sleep and Alzheimer's, not testing a new treatment. However, the findings could help lead to new treatments in the future.

What is a 'family carer' needed for?

They will help complete some of the questionnaires and diaries about your sleep and daily behaviour, as they know you well.

Do I have to live in France to join?

Yes, unfortunately, a requirement for this study is to be affiliated with the French social security system.

How to find out more

Yves Dauvilliers, MD

y-dauvilliers@chu-montpellier.fr +33467335219 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.