Collecting high-quality biomaterial from patients with neurodegenerative diseases and controls for diagnostic and prognostic biomarker investigation/validation, therapeutic applications and other research activities

Plain English summary of protocol

Background and study aims
As the global population gets older, age-related brain diseases, like Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS), are becoming more common. These conditions are often hard to diagnose early, and mistakes are frequent. When people are seen at specialist dementia clinics, about 1 in 4 with Alzheimer’s disease are incorrectly diagnosed. In some cases, these diseases are caused by inherited genetic mutations, but this is relatively rare (~ 20% of Parkinson’s cases have a clear genetic cause). Most cases happen for reasons that are not fully understood yet. This makes accurate diagnosis even more important and more challenging. Many degenerative brain diseases urgently need better ways to diagnose them earlier and track how well treatments are working (ideally through simple, non-invasive tests like blood samples). This study aims to better understand what causes neurodegenerative diseases like Alzheimer’s disease and Parkinson’s disease, trying to understand what makes each disease unique, while also separating these findings from changes simply related to aging. The study's researchers have discovered tiny particles in the blood (and potentially in other body fluids such as urine) that show promise as a new type of biomarker, a biological indicator that can help detect diseases more accurately in people who already have symptoms. Excitingly, they may also help spot people at risk before symptoms appear and track how the disease is progressing. This study is focused on gathering more samples from individuals with Alzheimer’s disease and Parkinson’s disease. This will help evaluate the feasibility of expanding the study to larger populations and potentially extending it to other diseases in the future. The study is also looking to identify new targets for future therapies. The focus is on finding biomarkers that can help predict who may develop a disease, diagnose it more accurately, and track how it progresses or responds to treatment. There is strong evidence that treatments for these diseases work best if started early. That is why there is an urgent need for simple, reliable tests using easily collected samples like blood and urine that can detect the disease in its earliest stages and monitor how it changes.

Who can participate?
Adult patients with a neurodegenerative condition and healthy volunteers who are aged 18 or older, of any gender, ethnicity, or background.

What does the study involve?
All participants will be identified by trained healthcare staff who understand how to assess mental capacity and follow up-to-date good clinical practice (GCP) guidelines. Some participants will not yet show symptoms of disease. These individuals are often identified when there is a known family history of the disease, especially if a genetic mutation linked to the disease has already been found in a close relative (such as a parent or sibling). Healthy volunteers will also be included in the study. These may be first-degree relatives (parents, siblings, or children) of patients, as well as partners, carers, or unrelated individuals. They may be recruited at the same clinics, either through established procedures or by expressing interest themselves (often because they are attending appointments with family members or loved ones).

Well-characterised disease cohorts are planned in Alzheimer’s disease and Parkinson’s disease, aiming to separate disease-specific features from general changes of age-related organ degeneration. Differences in expression levels of biomarkers derived from blood and urine derivatives between different groups (diseases and healthy controls) will be assessed.

The following types of samples will be collected from participants:
Blood Samples
• These may be taken during a routine medical appointment or during an extra visit, if needed.
• Blood will be used for research to find disease-specific biomarkers.
Urine Samples
• Urine will usually be collected at the same time as the blood sample.
• Like blood, urine will be used for biomarker research and other scientific studies.

Follow-Up Samples (Optional for patients)
• Some participants may be asked to give another sample within 6 months of the first one.

Participants will not undergo any treatment as part of this study. Any treatments they receive will be part of their standard medical care.

What are the possible benefits and risks of participating?
There may not be an immediate clinical benefit to participants in this study. However, the information gathered in this study will enhance our understanding and improve the treatment of people with rare disorders in the future, contributing to ongoing research in the UK and globally.

All results generated from this study, including scientific publications and intellectual property, will be carefully managed and shared as appropriate.

There are almost no risks to participants in this study. Trained healthcare staff will explain the procedures involved in collecting the sample. Some discomfort may be experienced during the withdrawal of blood samples.

Where is the study run from?
The study will be conducted and managed by the Surrey and Borders Partnership NHS FT (SABP) for the recruitment of Alzheimer’s disease and Parkinson’s disease patients and will be terminated after 3 years at the latest, when sufficient cohorts have been recruited to determine the validity of the biomarkers.

When is the study starting and how long is it expected to run for?
June 2025 to August 2028

Who is funding the study?
Vesalic Limited, UK

Who is the main contact?
1. Chloe Walsh, Research Co-Ordinator at SABP, research@sabp.nhs.uk
2. Pierpaolo Ala, Senior Project Manager at Vesalic, pier@vesalic.com

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centre

Results and Publications

Study outputs

Editorial Notes

16/09/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)