Alzheimer DiseaseBEAD-PCNCT07401849
Blood Biomarkers for Early and Accurate Diagnosis of Alzheimer's Disease in Primary Care
An observational study of Alzheimer Disease and Biomarkers / Blood, run by Imperial College London.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease, Biomarkers / Blood, Biomarker in Early Diagnosis
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients from 124 GP surgeries England.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Alzheimer-specific blood biomarkers
Amyloid and Tau protein biomarkers identified in blood sample
Measured: Day 1 (study entry)
Presence of Alzheimer-specific Cerebrospinal Fluid (CSF) biomarkers
Amyloid and Tau protein biomarkers found in CSF
Measured: Follow-up visit (around 6 months after study entry)
Secondary outcomes (2)
Montreal Cognitive Assessment (MoCA) score
Pen-and-paper cognitive test commonly used to identify Mild Cognitive Impairment (MCI) in older adults.
Measured: Day 1 (study entry)
CANTAB score
Online, self-completed battery of cognitive tests validated for detecting signs of AD-related cognitive decline.
Measured: Day 1 (study entry)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lefkos Middleton, Prof, Study chair, Imperial College LondonDavid Wingfield, Dr, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401849
- Sponsor's protocol ID
- EDGE 167698
- Other IDs
- 25/WS/0163
- Acronym
- BEAD-PC
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Biomarkers for Early and Accurate Diagnosis of Alzheimer's Disease in Primary Care
- ClinicalTrials.gov ID
- NCT07401849
- Acronym / sponsor ID
- BEAD-PC / EDGE 167698
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients from 124 GP surgeries England.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of Alzheimer-specific blood biomarkers
Time frame: Day 1 (study entry)
Amyloid and Tau protein biomarkers identified in blood sample
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
2 secondary outcomes
Montreal Cognitive Assessment (MoCA) score
Time frame: Day 1 (study entry)
CANTAB score
Time frame: Day 1 (study entry)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lefkos Middleton, Prof study chair
Imperial College London
David Wingfield, Dr principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Biomarkers / Blood, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (+44 20 7594 3894, beadpc@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Alzheimer-specific blood biomarkers (time frame: Day 1 (study entry)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.