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Enrolling by invitationOBSERVATIONAL

REAl World Dementia OUTcomes: Observational Study

This study, called READ-OUT, is looking into new blood tests that could help diagnose dementia earlier and more easily. It involves 3,165 men and women, aged 45 and over, who have memory concerns or a dementia diagnosis. Over three years, researchers will collect blood samples and ask people about their quality of life and healthcare. Some participants will also have follow-up checks after 2 weeks and 1 year. The main aim is to see how well these new blood tests work in spotting dementia in a typical UK population, compared to existing diagnosis methods. This could lead to better and earlier care for people with dementia.

At a glance

Status
Enrolling by invitation
Sponsor
University of Oxford
Enrolment target
3,165
Start
01 Nov 2024
Estimated completion
31 Oct 2029
Alzheimer Disease (AD)Mild Cognitive Impairment (MCI)Dementia

What is this study about?

Dementia affects many people in the UK, and it can be a really challenging condition for individuals and their families. Getting an accurate diagnosis early is very important so that people can get the right support and make decisions about their future care while they are still able to. Currently, diagnosing dementia often involves visits to memory clinics, memory tests, and sometimes brain scans like MRI. However, some advanced tests, like spinal fluid analysis, are expensive and not easily available to everyone.

Recent scientific breakthroughs have shown that simple blood tests can spot changes in the brain that are linked to dementia, especially Alzheimer's disease. These tests look for specific markers in the blood. So far, these blood tests have mostly been studied in smaller research groups. We need to check if they work just as well for all kinds of people in the UK before they can be used in routine care.

The READ-OUT study aims to bridge this gap. Researchers will collect blood samples from people attending memory clinics across 30 NHS sites, making sure that the study includes a wide range of people with memory problems. By comparing the results of these blood tests with current diagnostic methods, the study hopes to show that these new tests are reliable and accurate for everyone. This could change how dementia is diagnosed, making it quicker and easier for more people.

Key takeaways

  • Tests new blood tests for dementia in real UK memory clinics.
  • Aims for earlier and simpler dementia diagnosis.
  • Involves blood samples and questionnaires.
  • No new medicines, no changes to your current treatment.
  • Participation will last up to one year for some people.
  • Your involvement could help improve future dementia care.

Who may be eligible?

This study is looking for both men and women aged 45 or older. You could be eligible if you have been referred to a memory clinic because you have concerns about your memory or thinking. This includes people who just feel their memory isn't as good as it used to be (what doctors call 'subjective cognitive impairment'), or if you have already been diagnosed with a memory-related condition.

It's important that you (or someone legally acting on your behalf) are willing and able to understand and agree to take part in the study. If English is not your first language, support for translation will be available.

You won't be able to join the study if it's difficult to take a blood sample from your veins. Also, if you don't wish for the researchers to link your study information with your NHS health records (which helps them follow up on your health over time), then you won't be able to participate. This is because linking records is important for understanding the long-term impact.

Quick self-check
  • Are you 45 years old or older?
  • Have you been referred to a memory clinic or have concerns about your memory?
  • Are you able to agree to take part, or can someone legally act for you?
  • Are you willing for the researchers to link your study information with your NHS health records?
  • Do you have suitable veins for a blood test?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the READ-OUT study, you will be asked to provide a blood sample. This will be about 40ml, which is approximately three tablespoons. You will also complete some questionnaires. These questionnaires will ask about your quality of life, how you use healthcare services, and your thoughts on having a blood test for dementia.

For most people, that's the main part of their involvement. However, some participants will be asked to come back for additional follow-up appointments. These might be a short check-up after 2 weeks, and another full follow-up after 1 year. The total duration of your participation, if you're in the follow-up group, could extend up to one year. No new medications or treatments are involved in this study.

Potential risks and benefits

Taking part in this study could help us learn valuable information about new ways to diagnose dementia, which may benefit future patients. The main physical risk is from the blood draw, which might cause a little pain, bruising, or dizziness, similar to any standard blood test. You have the right to withdraw from the study at any time without giving a reason, and this decision will not affect your current or future medical care.

Locations (27)

  • Betsi Cadwaladr University Health Board
    Bangor, United Kingdom
  • ReMind UK
    Bath, United Kingdom
  • Belfast Health & Social Care Trust
    Belfast, United Kingdom
  • Dorset HealthCare University NHS Foundation Trust
    Bournemouth, United Kingdom
  • Berkshire Healthcare NHS Foundation Trust
    Bracknell, United Kingdom
  • Bradford District Care NHS Foundation Trust
    Bradford, United Kingdom
  • North Bristol NHS Trust
    Bristol, United Kingdom
  • Cambridgeshire and Peterborough NHS Foundation Trust
    Cambridge, United Kingdom
  • Devon Partnership NHS Trust
    Exeter, United Kingdom
  • Barts Health NHS Trust
    London, United Kingdom
  • East London NHS Foundation Trust
    London, United Kingdom
  • South London and Maudsley (SLaM)
    London, United Kingdom

+15 more sites — see the official record for the full list.

Common questions

What is the main goal of this study?

The main goal is to see if new blood tests can accurately spot dementia in real-life memory clinics across the UK.

Do I have to take any new medicine if I join?

No, this study does not involve any new medications or treatments. It's about blood tests and questionnaires.

How long will I be involved in the study?

Most people will have one main visit. Some might have follow-up checks at 2 weeks and 1 year, making their involvement up to one year long.

Will I get my blood test results from the study?

The study aims to understand whether people want to know their blood test results and how best to share this information. This will be discussed further during the consent process.

What if I change my mind after joining?

You can leave the study at any time without giving a reason, and it will not affect your medical care.

How to find out more

Official trial record

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

Interested in taking part?

Register your interest

Share your details and the research team for "REAl World Dementia OUTcomes: Observational Study…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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