The BEAD-PC Study
Research type
Research Study
Full title
Blood Biomarkers for Early and Accurate Diagnosis of Alzheimer’s Disease in Primary Care (the BEAD-PC study): An Implementation Study of novel blood biomarker and digital technologies in diagnostic pathways in primary and specialist care towards an earlier and accurate diagnosis of Alzheimer’s disease.
IRAS ID
340811
Contact name
Lefkos Middleton
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 2 months, 29 days
Research summary
Alzheimer’s Disease (AD) is a degenerative condition affecting the brain. Achieving accurate and prompt detection of AD pathology at early stages is currently a significant hurdle.
The aim of this pragmatic study is to introduce and evaluate the impact of blood biomarkers (BBM) based primary care diagnostic pathway to aid in early and accurate diagnosis of AD and assess its consistency with established diagnostic cerebrospinal fluid (CSF) analysis.
GPs from participating Northwest London boroughs (such as Hammersmith and Fulham, Hillingdon, Westminster, Hounslow, and Kensington and Chelsea) will refer eligible patients (over 55 with recent memory problems) to primary care Cognitive Assessment Clinics which will be set up in each borough as part of this study. There, patients will undergo the Montreal Cognitive Assessment (MoCA) memory test, and blood biomarker testing. Individuals with a MoCA <26, or those with positive BBM results will be referred to the Imperial Memory Unit (IMU) at Imperial College Healthcare NHS Trust. At IMU, they will undergo further cognitive testing, RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) and a lumbar puncture for confirmatory CSF analysis.
A diagnosis of AD is made if the patient meets the criteria from the results of clinical assessments and investigations. Patients will then be discharged back to their primary care team or local memory clinic with management advice and re-referral guidance.Separately, as an exploratory objective looking at introduction of self-complete digital cognitive assessments in primary care, patients will complete a digital test (CANTAB or XpressO) during their CAC visit, results will be blinded and not form part of decision pathway.
Study recruitment will be for 9 months and there will be a 6 month follow-up period. We aim for a sample size that utilizes the available BBM (n=1000) assays and CSF (n=375) test kits provided by C2N and Roche respectively.
REC name
West of Scotland REC 3
REC reference
25/WS/0163
Date of REC Opinion
21 Nov 2025
REC opinion
Further Information Favourable Opinion