Professor Vanessa Raymont is an Associate Professor at the University of Oxford and an Honorary Consultant Psychiatrist at Oxford Health NHS Foundation Trust. She is a highly experienced psychiatrist with over 25 years research experience in the UK and USA. In this blog, she writes about the READ-OUT study into blood tests for dementia.

Clinical trials have been a big part of my work as a psychiatry specialist for the past three decades. Besides trials, I’m deeply involved in projects like READ-OUT, exploring new dementia biomarkers. My primary interest, alongside trials and biomarker work, lies in translational research. The READ-OUT (REAl World Dementia OUTcomes) study definitely fits that bill.

Alongside my clinical work, I am one of the Associate Directors for Dementia Platform UK (DPUK). This is a partnership of public, academic and third sector organisations focused on early phase breakthroughs. I am also a Joint Deputy Chair for NIHR Dementia Translational Research Collaboration.

The Blood Biomarker Challenge

When Alzheimer’s Research UK (ARUK) put out a call for the Blood Biomarker Challenge over a year ago, I was immediately interested. They were looking for projects focused on the use of blood biomarkers in memory clinics, specifically in secondary care, and with a strong health economics component. 

The idea was to create a template for wider NHS rollout, with a strong emphasis on real-world data and creating a pathway for these biomarkers to be used in services. This was very different from typical research grants, where implementation into services can often take a long time.

We submitted a successful bid from DPUK, working with colleagues to emphasise using our existing network of sites. In DPUK, our framework includes registers of people who are healthy or have very early disease, and we are creating a register for people in memory clinics.

We have a network of 78 memory clinics across the UK so far. This is helping us fulfill our aim to reach more under-served people from ethnic and socioeconomic backgrounds, as well as those with comorbidities and the very elderly people, who are often excluded. 

The READ-OUT Study

The READ-OUT study, which is funded by the NIHR, focuses on identifying the best set of biomarkers for Alzheimer’s disease and other types of dementia. This complements the work of the Adapt study, which is focusing on a single, promising biomarker for Alzheimer’s. We believe the real world involves multiple pathologies and combinations, so we need to find the best panel of biomarkers for both diagnosis and prognosis.

A key aspect of our project is ensuring representativeness. We aim for 30% of our recruitment sample to come from underrepresented groups, particularly based on ethnicity and comorbidities. We will begin by opening 28 of our 78 sites, selected because they can access these populations and we already have engagement with local communities.

This observational study will be open for three years, having launched last year, with our first participant recruited on 1 December 2024. This study involves a simple blood test, and we plan to recruit over 3,000 people. These will be people with a memory diagnosis who have disengaged with secondary care.

This data will help us select a panel of biomarkers, which we’ve divided into three tiers: tier one with established evidence and clinical availability, tier two with good research evidence but not yet clinically available, and tier three with exploratory biomarkers from industry partners. We’ll use this panel in a randomised controlled trial in the last two years of the project, looking at the benefit of receiving biomarker status for both patients and clinicians.

The primary outcome measure from this trial will be quality of life, alongside measures of anxiety, depression, health economics data, and the wider effects such as impact on carers. This part of the study will recruit just under 900 people, and we are working with 14 Integrated Care Boards (ICBs) to ensure we gather the right data for potential NHS rollout.

Involving the public in research

We have a strong Patient and Public Involvement panel led by Dr Ben Underwood (NIHR Research Delivery Network Dementia and Neurodegeneration Lead for the East of England), which is being enhanced with people from specific underrepresented groups. A key aspect of the panel’s work is how we communicate biomarker results, as there’s a whole science around communicating risk. The tests involved in the trials often involve grey areas rather than clear yes/no answers, so we need to ensure patients and clinicians understand the results, and are reassured that they can ask any questions they have about them.

We’ve had our first site open since the end of last year and are opening more of our sites all the time. The government’s Dementia Goals Program has now also funded digital cognitive tests at ten of our sites to complement the blood tests. 

“An exciting time for dementia research”

The first time I worked in a memory clinic was in 1994 when Aricept (donepezil) had just been approved. In 30 years, things sadly haven’t changed much in memory clinics, however, we now have the opportunity for better risk management, new drugs, and more accurate diagnoses with blood tests. This is an exciting time for dementia research.

In the next ten years, I think we will see more biomarkers available, wider drug availability, and a greater focus on prevention. We know 45% of dementia could be preventable, with hearing loss being the biggest risk factor. I hope people will start talking about dementia as something treatable and potentially preventable, like cancer or heart disease.

I believe we need to invest more in memory clinics to provide better support and services, so we can support patients in a similar way to those on the cancer pathway. It’s not just about drugs and blood tests, but about supporting people and giving them help when they need it.

Find out more about the READ-OUT study.

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