Blood Biomarkers for Early and Accurate Diagnosis of Alzheimer's Disease in Primary Care

NCT07401849 | Not Yet Recruiting DMC

• 2 other identifiers: EDGE 16769825/WS/0163
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alzheimer Disease; Biomarkers / Blood; Biomarker in Early Diagnosis; Mild Cognitive Impairment (MCI)

Keywords

Alzheimer's Disease; Memory complaints; Mild Cognitive Impairment; Primary care; Blood biomarkers; Neuropsychological assessment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Montreal Cognitive Assessment (MoCA) score

  Day 1 (study entry)

• CANTAB score

  Day 1 (study entry)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients from 124 GP surgeries England.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Imperial College London: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Cerebrospinal Fluid

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Lefkos Middleton, Prof

  Imperial College London

  STUDY CHAIR

• David Wingfield, Dr

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

+44 20 7594 3894; beadpc@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 11, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02