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NCT Number: NCT07401849

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Presence of Alzheimer-specific blood biomarkers

    Time frame: Day 1 (study entry)

    Amyloid and Tau protein biomarkers identified in blood sample

  2. Presence of Alzheimer-specific Cerebrospinal Fluid (CSF) biomarkers

    Time frame: Follow-up visit (around 6 months after study entry)

    Amyloid and Tau protein biomarkers found in CSF

Secondary outcomes

  1. Montreal Cognitive Assessment (MoCA) score

    Time frame: Day 1 (study entry)

    Pen-and-paper cognitive test commonly used to identify Mild Cognitive Impairment (MCI) in older adults.

  2. CANTAB score

    Time frame: Day 1 (study entry)

    Online, self-completed battery of cognitive tests validated for detecting signs of AD-related cognitive decline.

Study contacts

Contact information is provided by the study sponsor or research team.

Project Manager

CONTACT

[email protected]

+44 20 7594 3894

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: BEAD-PC

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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