Blood Biomarkers for Early and Accurate Diagnosis of Alzheimer's Disease in Primary Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Biomarkers / Blood, Biomarker in Early Diagnosis, Mild Cognitive Impairment (MCI). Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Presence of Alzheimer-specific blood biomarkers [Time frame: Day 1 (study entry)]
- Presence of Alzheimer-specific Cerebrospinal Fluid (CSF) biomarkers [Time frame: Follow-up visit (around 6 months after study entry)]
Secondary outcome measures (2)
- Montreal Cognitive Assessment (MoCA) score [Time frame: Day 1 (study entry)]
- CANTAB score [Time frame: Day 1 (study entry)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Ecologic or community
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07401849 · EDGE 167698 · 25/WS/0163