Active not recruitingOBSERVATIONAL

Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease

This study, called 'Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease,' is looking for people with mild memory and thinking difficulties to help research a new way to diagnose Alzheimer's disease earlier. The main goal is to see if a special type of MRI scan analysis, called Cortical Disarray Measurement (CDM), can spot changes in the brain that are linked to Alzheimer's. Over two years, researchers will track participants’ memory and thinking skills and compare them with the CDM results. This will help understand how CDM relates to these changes over time. They also want to gather experiences from patients and their companions about the journey of getting a dementia diagnosis and how this new technique might help in the future.

At a glance

Status

Active not recruiting

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

400

Start

28 Sep 2022

Estimated completion

01 Sep 2026

Mild Cognitive Impairment Alzheimer Disease Dementia

What is this study about?

This study aims to investigate a new way to help diagnose Alzheimer's disease earlier. It focuses on a special imaging technique called Cortical Disarray Measurement (CDM), which uses advanced analysis of MRI scans of the brain. The idea behind CDM is that it might be able to detect subtle changes in the brain's grey matter that are linked to conditions like mild cognitive impairment (MCI) and early Alzheimer's disease.

The researchers are keen to find out if CDM can accurately identify these changes in people who are already experiencing some memory and thinking problems. Over a two-year period, they will regularly assess participants' memory and thinking abilities and compare these with the CDM results. This will help them understand if CDM can predict how someone's memory and thinking might change over time. They also want to understand how CDM could fit into current diagnostic practices and what the potential benefits might be for patients and their families.

Beyond the scientific aspects, the study also includes an important element of understanding people's experiences. The research team wants to hear from both patients and their companions (like a family member or close friend) about their journey through the process of getting a diagnosis for memory problems. This input is crucial for making sure that any new diagnostic tools, like CDM, are not only effective but also helpful and reassuring for those who might benefit from them.

Key takeaways

This study investigates a new MRI analysis method (CDM) for early Alzheimer's diagnosis.
It aims to understand how CDM relates to memory changes over two years.
Participants must have mild memory problems or early Alzheimer's disease.
No new medications are given; it's an observational study.
Requires regular visits for MRI scans, blood tests, and memory assessments.
A companion (family/friend) who knows you well must also participate.

Who may be eligible?

This study is looking for people aged between 50 and 90 years old. If you have been diagnosed with mild memory problems (often called Mild Cognitive Impairment, or MCI) or early Alzheimer's disease, you might be able to take part. The research team will need to confirm your specific diagnosis through certain criteria.

You also need to be able to have and comfortably tolerate MRI scans, which are detailed brain scans, and be able to provide blood samples. Importantly, you must be able to understand and agree to take part in the study yourself, and you'll need to have a companion (like a spouse, partner, or close friend) who knows you well. This companion will also participate by answering questions about your condition.

You might not be able to participate if you have a non-progressive learning disability (meaning it doesn't get worse over time), if you are pregnant or planning to become pregnant during the study, or if your chosen companion doesn't know you well enough to provide helpful information or isn’t fluent in English. The study team will review all details to ensure it's a good fit for everyone involved.

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 90 years old?
Have you been diagnosed with mild memory problems (MCI) or early Alzheimer's disease?
Are you able to have MRI scans and blood tests comfortably?
Do you have a companion (family/friend) who knows you well and can also participate?
Are you able to understand and agree to take part in the study yourself?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will last for two years. During this time, you will have regular visits to the research centre where you will undergo various assessments. These will include MRI brain scans to capture the detailed images needed for the Cortical Disarray Measurement analysis, and you will also have blood samples taken. Your memory and thinking skills will be assessed periodically through standard tests. Your companion will also be involved, attending some visits or participating remotely, to answer questions about your condition and how it affects your daily life. No new medications are given as part of this study; it focuses on observation and assessment. After the two years, your participation in the study will conclude.

Potential risks and benefits

Participating in this study might offer several potential benefits. It provides an opportunity to contribute directly to advancing our understanding and diagnosis of Alzheimer's disease, which could ultimately lead to better care for others in the future. You will also receive regular monitoring of your cognitive health by medical professionals throughout the study. However, like any medical research, there are potential risks. These are generally low for this type of observational study and primarily relate to the MRI scans (e.g., discomfort in the scanner, but no radiation exposure) and blood draws (e.g., bruising). You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

University Hospital Southampton NHS Foundation Trust
Verified postcode
Southampton, United Kingdom
Dorset Healthcare University NHS Foundation Trust
Verified postcode
Bournemouth, United Kingdom
Cardiff and Vale University Health Board
Verified postcode
Cardiff, United Kingdom

Common questions

What is Cortical Disarray Measurement (CDM)?

CDM is a new way to analyse detailed MRI brain scans. It looks for subtle changes in the brain's structure that might be linked to early Alzheimer's disease.

Will I receive new medication?</q>

No, this study does not involve taking any new medications. It is an 'observational' study, meaning we are observing and measuring things without introducing new treatments.

What does 'mild cognitive impairment' mean?

Mild cognitive impairment (MCI) means you have some memory or thinking problems that are more than expected for your age, but they are not severe enough to significantly interfere with your daily life.

How long will my involvement last?

If you join the study, your participation will last for two years, with regular check-ups and assessments during that time.

Do I need to bring someone with me to appointments?

Yes, you will need a companion (a family member or close friend who knows you well) to take part in some aspects of the study, either in person or remotely.