Not yet recruitingOBSERVATIONAL

Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages

The NeuroPrems study aims to find early signs of brain diseases that affect memory and movement, like Alzheimer's or Parkinson's, even before someone shows any symptoms. Researchers are looking at various measurements, including special brain scans (PET and MRI), eye and movement tests, and blood samples, to track changes over time. They want to understand how these conditions develop and identify 'markers' that could help detect them earlier. This is a research study, not testing a new medicine, and it's for people who might be at higher risk of these conditions, as well as healthy volunteers, to compare the findings.

At a glance

Status

Not yet recruiting

Sponsor

Paris Brain Institute (ICM)

Enrolment target

1,000

Start

01 Sep 2024

Estimated completion

31 Aug 2034

Neurodegenerative Diseases

What is this study about?

This study, called NeuroPrems, is trying to understand brain diseases that get worse over time, like Alzheimer's or Parkinson's. These conditions often start causing changes in the brain many years before a person notices any symptoms. The main goal of this research is to find these early changes, often called 'markers,' which could help doctors identify people at risk much sooner.

Researchers will use a variety of tests to look for these markers. This includes detailed brain scans like PET scans and MRI scans, which can show what's happening inside the brain. They will also look at things like eye movements, how a person walks and stands, their voice, and sleep patterns. Additionally, blood, skin, and waste samples will be collected, and some participants might have a lumbar puncture (spinal tap) to get a sample of fluid from around the brain and spinal cord.

By carefully checking these things over time in people who are at higher risk but don't yet have symptoms, as well as in healthy volunteers, the study hopes to learn how these diseases develop. This knowledge is important because it could lead to better ways to diagnose these conditions early and eventually, better treatments to slow or stop their progress.

Key takeaways

Aims to find early signs of brain diseases before symptoms appear.
Uses various tests including brain scans, eye tests, and body checks.
No new medicines are given as part of this study.
Important for understanding how brain conditions develop.
You can withdraw from the study at any time.
Requires regular visits and tests over a longer period.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and agree to take part. You must be able to have an MRI scan, which is a special type of body scan.

If you have a higher chance of developing a brain condition but don't yet have symptoms, you might be eligible. This could be because a close family member has a genetic risk, you have a specific sleep disorder, or doctors have spotted early brain changes on a scan or in other tests, even if you feel fine. We also need healthy volunteers who don't have any brain disease symptoms to compare with.

However, you cannot join if you already have symptoms of a brain disease, or if you cannot have an MRI scan for medical reasons (like having certain metal implants). You also can't participate if you are pregnant or breastfeeding, or if you can't understand what the study involves. We need everyone to be willing to be told if an MRI scan reveals something unexpected, even if it's not related to the 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 18 years old or older?
Can you have an MRI scan safely (no certain metal implants)?
Are you willing to know if we find something unexpected on your MRI?
Do you *not* currently have symptoms of a brain disease?
Are you *either* at higher risk of a brain disease *or* a healthy volunteer?
Are you able to understand the study information and give your consent?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will have regular appointments over time. These appointments will involve various assessments. You'll have special brain scans (PET and MRI), tests of your eye movements, how you walk, and your posture. Researchers will also record your voice and monitor your sleep. You'll need to provide blood, urine, and stool samples. Some participants may also have a skin biopsy (a small sample of skin) and a lumbar puncture, which involves collecting a small amount of fluid from your spine. This study does not involve taking any new medications. The total duration of your involvement will depend on the study's plan, but it will be a long-term commitment to track changes over time.

Potential risks and benefits

Taking part in this study won't directly improve your health, but the information gained is incredibly valuable. It could help us understand these conditions better, leading to earlier diagnosis and future treatments for others. There are some small risks involved, such as discomfort from blood draws, skin biopsies, or lumbar punctures, and MRI scans involve strong magnets. You'll also be exposed to a very small amount of radiation during PET scans. We will tell you about any unexpected findings from your scans, which might cause worry. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Pitié Salpêtrière Hospital
Verified postcode
Paris, France

Common questions

What kind of brain diseases are you looking for?

We are looking for early signs of diseases like Alzheimer's and Parkinson's, which are conditions that affect the brain over time.

What is a 'presymptomatic' stage?

This means we're studying people who don't yet have any noticeable symptoms of a brain disease, but might be at higher risk.

Will I get any medicine in this study?

No, this study is purely observational. You won't be given any new medicines to take.

What happens if you find something unusual on my scans?

If we find something significant that needs medical attention, we will inform you and your doctor.

How long will I have to be in the study?

This is a longitudinal study, meaning we will follow participants over time to track changes, so it will involve multiple visits over an extended period.

How to find out more

Pierre GEORGES FRANCOIS

riph@icm-institute.org 01 57 27 40 00 Official trial record

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