Real world Dementia Outcomes: Observational Study (READ-OUT)
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Overview
Recently, blood-based biomarker tests have demonstrated promising results in terms of both detecting dementia pathology and assessing the risk for developing dementia in ageing adults. In this study, we will check how good these blood tests are in terms of supporting a dementia diagnosis, how well they perform in a real-world population, and whether they are good value for money for the NHS.
Summary
What is the study about?
Dementia is a growing concern in the UK and is likely to affect over half the population. New drugs to treat Alzheimer’s disease, the main cause of dementia, have been developed, but they require expensive and invasive tests to prove that a patient has Alzheimer’s disease.
Recently, blood-based biomarker (i.e., a naturally occurring molecule that is a sign of normal or abnormal process, condition or disease) tests have demonstrated promising results in terms of both detecting dementia pathology and assessing the risk for developing dementia in ageing adults.
What are you trying to find out?
In this study, we will check:
- how good blood tests for dementia are in terms of supporting a dementia diagnosis;
- how well these tests perform in a real-world population (i.e., people from minority groups, who have significant medical conditions, are of advanced age);
- whether the blood tests for dementia are good value for money for the NHS.
Who is it for?
You have been invited to take part in this study because you are aged 45 years or older AND because you either:
- Have been diagnosed with dementia or Mild Cognitive Impairment by healthcare professionals or at a Memory Clinic OR
- A clinician has a record of you presenting with memory complaints.
In this study, we will recruit up to 3,165 participants from across the United Kingdom.
Sometimes people with cognitive difficulties will not be able to make the decision for themselves in a reliable way as to whether to take part. In this case we will consult with your next of kin or close friend to help confirm the study is what you would want to participate in. In the event that you lose capacity during the trial, we will seek advice from your next of kin or close friend who can act on your behalf, as a consultee, regarding whether or not you should remain in the study.
What does taking part involve?
In this study we are going to:
- Take a single blood sample of 20 mL, roughly the same as 1.5 tablespoons.
- Ask you questions about your medical history and demographics.
- Ask you to complete a questionnaire about your feelings toward dementia diagnosis and whether blood tests may be a useful tool for your medical care.
- Analyse the blood samples to look at the levels of proteins and your genetic make-up and link this to your clinical and demographic information.
- As this is a rapidly developing field, we will retain parts of the blood samples for future analyses for which we will ask for your consent for future research use.
You will have the option to participate in up to three optional sub-studies. In those studies:
- You may be asked to return in 1-2 weeks to give a further 20 mL sample (approximately 1.5 tablespoons). The sample will be processed after some delay. This will allow us to check what the maximum delay to processing samples is.
- You may be asked to return in 12 months to give a further 20mL sample (approximately 1.5 tablespoons). This will allow us to check how stable the blood tests for dementia are over a short period of time.
- You may be asked to provide a few drops of blood via a blood spot card (similar to how people with diabetes check their blood sugar levels). We will then give you a blood spot card to repeat the same procedure at home. We will give you a pre-paid envelope to send back to us. This experiment will allow us to check if blood spot cards are a good alternative to having blood taken in clinic.
Why is it important?
Dementia is a growing concern in the UK and is likely to affect over half the population. New drugs to treat Alzheimer’s disease, the main cause of dementia, have been developed, but they require expensive and invasive tests to prove that a patient has Alzheimer’s disease.
How can I find out more?
You can find out more information about taking part in this study by downloading the key documents at the top of this page.
If you are interested in taking part in this study, or have questions for the research team, click the button below to email us:
Meet the researcher
Ross DunneLater Life Psychiatrist and Dementia Specialist
I'm Ross Dunne, a later life psychiatrist and dementia specialist working in GMMH. I am also the clinical director of the Greater Manchester Dementia Research Centre, the region's leading clinical trial unit for the diseases causing dementia. My research focusses on simpler ways to diagnose the underlying causes of dementia, and assessing treatments to help slow dementia or improve symptoms.