RecruitingNAINTERVENTIONAL

Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study

This study, called 'INSIGHT-2', is a follow-up for people who previously took part in the 'INSIGHT' study on memory. It aims to understand how Alzheimer's disease progresses in its very early stages, particularly in those who have reported memory problems. The researchers will follow around 240 participants for another 5-6 years, checking them once a year. They'll use different tests, including brain scans, to see how memory and brain health change over time. A key focus is on those individuals who showed signs of amyloid protein (a substance linked to Alzheimer's) in their brain scans, to see if they go on to develop symptoms of the disease. The overall goal is to learn more about how Alzheimer's starts and progresses.

At a glance

Status

Recruiting

Phase

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Enrolment target

240

Start

14 Apr 2023

Estimated completion

09 Oct 2030

Alzheimer Disease Memory Complaint Memory Disorders

What is this study about?

This study is a follow-up to a previous research project called the INSIGHT study. Its main purpose is to learn more about how Alzheimer's disease develops over a long period, especially in people who have noticed some changes in their memory but don't yet have full-blown dementia. Doctors and researchers want to understand the very early stages of Alzheimer's, sometimes called 'preclinical' Alzheimer's, before noticeable symptoms appear.

Participants in this study will be people who were already part of the first INSIGHT study. Researchers will continue to monitor them for an extra five to six years. During this time, they will have yearly check-ups that involve a range of tests. These tests are designed to look at different aspects of brain health, including memory and thinking skills, eye movements, blood tests, and special brain scans.

A key part of this study is looking at a protein called amyloid, which can build up in the brains of people with Alzheimer's. Some participants in the original INSIGHT study had brain scans that showed signs of this amyloid protein. The researchers are especially interested in following these individuals to see if they eventually develop symptoms of Alzheimer's disease. By doing this, the study hopes to gain a better understanding of the early signs and progression of Alzheimer's, which could help in developing future treatments.

Key takeaways

This study tracks the very early stages of Alzheimer's disease.
It follows people who were in a previous memory study.
Participants will have yearly check-ups including various brain tests and scans.
The study aims to understand how memory changes relate to Alzheimer's over several years.
Your participation helps advance understanding of Alzheimer's for future treatments.

Who may be eligible?

To be able to join this study, you must have previously taken part in the original INSIGHT study. You also need to be between 70 and 95 years old. It's important that you're willing and able to have a special brain scan called a PET amyloid scan. You must also be signed up with the French health-care system, as the study is based there.

Another important aspect is that you should have a good friend, family member, or carer who knows you well and can provide details about your memory and daily activities. This person should be able to speak with the study team, even if it's just over the phone.

There are also reasons why you might not be able to join. For example, if you already have a diagnosis of dementia or other serious brain conditions, or if you have certain major health issues that could make taking part in a study risky. Also, if you have conditions that prevent you from having an MRI or PET scan, like claustrophobia or metal in your body, you wouldn't be able to join. Lastly, if you've recently taken part in another type of medical research study that involves new medications or treatments, you might not be eligible.

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.

I was part of the original INSIGHT study.
I am aged between 70 and 95.
I am willing and able to have brain scans (like PET amyloid scans).
I have a friend or family member who knows me well and can talk to the study team.
I do not have a current diagnosis of dementia or certain other serious health problems.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have yearly visits to the study centre. These visits will involve several different tests. You might have an Electroencephalogram (EEG), which measures brain activity; eye movement tests; an MRI scan, which gives detailed pictures of your brain; and special PET scans to look at specific brain activities and proteins. You will also have blood samples taken and, for some, a lumbar puncture (a 'spinal tap') will be offered, which involves taking a small sample of fluid from your spine.

These yearly visits and tests will help the researchers track any changes over time. Compared to the original INSIGHT study, the visits for this follow-up will be less frequent, happening once a year instead of every six months. The entire follow-up period for this extension study is expected to last for another 5 to 6 years.

Potential risks and benefits

Taking part in this study may not directly benefit your health, but the information gathered will be extremely valuable. It could help doctors and researchers better understand how Alzheimer's disease starts and progresses, leading to new ways to diagnose and treat it in the future. As with any medical study, there are some potential risks. These might include minor discomfort from blood tests or lumbar punctures, or reactions to the dyes used in some scans. There's also the normal risk associated with existing medical scans like MRI and PET. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hôpital Pitié Salpêtrière
Verified postcode
Paris, France· Recruiting

Common questions

What is the main goal of this study?

The study aims to understand how Alzheimer's disease develops in people who have noticed memory changes, particularly those with early signs of the disease in their brain.

Do I need to have a specific memory problem?

You need to have previously participated in the INSIGHT study, which focused on people with subjective memory complaints, meaning they noticed changes themselves.

What kind of tests will I have?

You'll have yearly check-ups including brain scans (MRI, PET), brain activity tests (EEG), eye movement tests, blood tests, and potentially a spinal fluid test.

How long will I be in the study?

You will be followed for an additional 5 to 6 years, with yearly visits and tests.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without any impact on your medical care.

How to find out more

Nadjia YOUNSI

nadjia.younsi@icm-institute.org +331 42 16 75 15 Official trial record

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