Blood Biomarkers for Early and Accurate Diagnosis of Alzheimer's Disease in Primary Care (BEAD-PC)

Alzheimer's disease is a degenerative condition affecting the brain and is the most common form of dementia in older adults. Dementia is currently a major healthcare issue in the UK, affecting approximately a million people. The progression of the disease varies between individuals and the early stages may be characterised by only minimal changes in memory and thinking. These changes could remain undetected as the symptoms may be mistakenly regarded as normal age-related forgetfulness. However, dementia is not part of the normal ageing process.

The underlying biological disease process of Alzheimer's is now known to start at least 20 years prior to patients showing any symptoms. A protein called amyloid starts to deposit in the brain and forms clumps referred to as 'plaques'. Another protein called tau collects inside brain cells and forms structures called 'tangles'. These biological changes can disrupt the normal functioning of brain cells and ultimately destroy them, leading to a reduction in brain volume and ability.

The aim of the BEAD-PC study is to assess whether a specific blood test in primary care can help diagnose Alzheimer's disease at an early stage.

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment (MCI); Alzheimer Disease; Biomarker in Early Diagnosis; Biomarkers / Blood

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Project Manager; Phone Number: +44 20 7594 3894; Email: beadpc@imperial.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients from 124 GP surgeries England.

Description

Inclusion Criteria:

• Age 55 years and above
• Presence of self-reported symptoms indicative of cognitive decline or concerns family members/partners indicative of cognitive decline
• Capacity to consent
• Be fluent in and able to read and write in English and have adequate hearing and visual acuity to complete the required psychometric tests.

Exclusion Criteria:

• Insufficient vision and hearing
• Prior diagnosis of ADRD. Prior diagnosis of Alzheimer's disease or related dementia (with or without evidence of pathology), through clinical diagnosis and/or as documented in their medical record
• Pre-existing diagnosis of dementia
• Incidental findings of brain pathologies on brain MRI, such as cancerous space occupying lesions and clinically significant vascular malformations and recent (within 12 months) macro-infarcts, that are, also exclusionary
• Contraindication for Lumbar Puncture
• Involvement in interventional research study within 3 months prior to screening
• For any other reason, in the opinion of the Investigator, participating in the study is not in the best interest of the patient.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Alzheimer-specific blood biomarkers	Amyloid and Tau protein biomarkers identified in blood sample	Day 1 (study entry)
Presence of Alzheimer-specific Cerebrospinal Fluid (CSF) biomarkers	Amyloid and Tau protein biomarkers found in CSF	Follow-up visit (around 6 months after study entry)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA) score	Pen-and-paper cognitive test commonly used to identify Mild Cognitive Impairment (MCI) in older adults.	Day 1 (study entry)
CANTAB score	Online, self-completed battery of cognitive tests validated for detecting signs of AD-related cognitive decline.	Day 1 (study entry)

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Study Chair: Lefkos Middleton, Prof, Imperial College London; Principal Investigator: David Wingfield, Dr, Imperial College London

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Primary care; Mild Cognitive Impairment; Neuropsychological assessment; Blood biomarkers; Memory complaints
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease
• Other Study ID Numbers: EDGE 167698; 25/WS/0163 (Other Identifier: Research Ethics Committee (REC))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No