In 2022, dementia and Alzheimer’s disease was the leading cause of death in the UK and with approximately 33% of the UK population aged fifty or above, there is growing concern regarding the percentage of this demographic who may develop AD in the coming years.

A new service development project, run by Dementias Platform UK (DPUK) supported under a Collaborative Working Agreement by Eli Lilly and Company and Oxford Health NHS Foundation Trust has been launched at the Oxford Health Clinical Research Facility (OH CRF).

The project will pilot a clinical pathway for the early and accurate diagnosis of AD, including biomarker assessment via cerebrospinal fluid (CSF) which hopefully, can then be implemented across other NHS Trusts.

A biomarker is a measurable molecular, cellular, or biochemical change in the body that helps identify and monitor physiological and disease processes or responses to treatments.

Biomarkers are present in blood, other body fluids (such as CSF), organs and tissues.

The National Institute on Aging–Alzheimer’s Association (NIA-AA) has recently recommended CSF biomarker testing to complement existing diagnostics in order to improve the accuracy of an AD diagnosis and enable staging of the disease.

Unfortunately, most NHS memory clinics do not have access to appropriate resources to offer CSF biomarker testing, especially those based in Mental Health Trusts, where most memory clinics are located.

This project will attempt to address and validate the processes for building capacity for biomarker testing in NHS Mental Health Trust-based memory clinics nationally. CSF testing capacity will be developed at OH CRF and three other UK sites to act as a pilot for future implementation of this service and provide a blueprint to best support CSF testing in memory clinics and increase testing capacity at scale.

Overall, this project specifically aims to:

• improve diagnostic accuracy of dementias including AD.
• validate the benefits of early diagnosis.
• understand what is required to deliver CSF testing in memory clinics.
• develop a case to commission CSF testing.

This Biomarker project is a multi-site pilot program across 4 NHS Mental Health Trusts, facilitated by the DPUK Trial Delivery Framework (TDF). These sites (Manchester, Brighton, Sheffield and Oxford) service diverse socio-economic and ethnic populations; crucial for establishing the utility of generalisable biomarker testing across all people visiting NHS memory clinics.

Each site involved in the study will recruit approximately one hundred participants deemed to benefit from CSF testing by an attending clinician after an initial referral and diagnostic scan. Each of the participants will be scheduled for a lumbar puncture for CSF extraction and testing. Once processed, results will be provided to patients via their memory clinic doctor. Comparisons to initial diagnoses with those reached following CSF testing to assess diagnostic accuracy will then be made.

This information together with other patient data collected throughout the project, will validate the utility, feasibility and health economic benefit of CSF testing, and will be fed back to the NHS to determine whether more sites should be equipped to provide this service nationally.

Prof V Raymont

Lead researcher Director of R&D at Oxford Health NHS Foundation Trust and Associate Director of DPUK Prof Vanessa Raymont said: “This type of project enables us to develop and deliver the best service we can for people attending memory clinics, at a time of huge change in new biomarkers and treatment for Alzheimer’s disease. I look forward to working with the OH CRF to offer CSF testing to patients across Oxfordshire and Buckinghamshire.”

For more information about the CSF project please email: oxfordhealthCRF@nhs.net