Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
3165 participants
OBSERVATIONAL
2024-11-01
2029-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Participants provide blood samples and complete questionnaires about quality of life and healthcare use, with some having additional follow-ups at 2 weeks and 1 year. The study will assess reliability and accuracy of blood tests in diagnosing dementia.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Identification of Predictors for Early Cognitive Decline in Men
NCT03290040
A Cohort of Outpatients From French Research Memory Centers in Order to Improve Knowledge on Alzheimer's Disease and Related Disorders
NCT01926249
Cognitive Health in Ageing Register: Investigational, Observational and Trial Studies in Dementia Research: Prospective Readiness Cohort Study
NCT02114372
Biomarkers in a Candian Memory Clinic
NCT06843109
Validation of Blood Biomarkers for Alzheimer's Disease
NCT05427448
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Current dementia diagnosis in memory clinics relies on clinical assessment, cognitive testing, and brain scans (MRI or CT). Only a small proportion of UK patients have access to more specific tests like PET brain scans or spinal fluid analysis, which are expensive and not widely available.
Recent developments have shown that blood tests can accurately detect the underlying brain changes of dementia, particularly Alzheimer's disease. In research studies, these blood-based biomarkers (ptau217, AB42/40 ratio, GFAP, NFL etc) have successfully identified people with Alzheimer's disease when compared to clinical diagnoses, gold standard brain scans, and post-mortem brain examination. These blood tests also show promise for predicting people with future dementia risk.
However, most research has been conducted in younger, less diverse populations than those seen in real-world memory services. Blood-based biomarkers are not yet used in routine NHS practice, and more work is needed to test how well they perform in representative UK populations. We also need to understand whether people want to know their blood test results, what information they want, and how this is best communicated.
The READ-OUT study will test blood-based biomarkers in people attending memory clinics across the UK (30 NHS sites), ensuring participants represent the full diversity of people with dementia or memory concerns (30% from underrepresented groups). Participants will provide a 40ml blood sample and complete questionnaires about quality of life, healthcare use, and attitudes toward blood testing for dementia. The accuracy of blood biomarkers will be compared against established diagnostic methods including expert clinical review, brain scans, spinal fluid tests, and long-term health record follow-up.
The study includes three optional sub-studies: test-retest reliability of blood biomarkers (10% of participants returning after 1-2 weeks), investigating disease progression over one year (20% of participants), and evaluating whether people can collect blood samples at home using finger-prick cards (75 participants).
The study will determine which blood biomarkers are most accurate for diagnosing different types of dementia, predict disease progression, and assess their cost-effectiveness in the healthcare system. Results will inform whether these tests should be integrated into NHS clinical pathways and will guide the design of READ-OUT Phase 2, a randomized trial testing whether providing blood biomarker results to patients and doctors improves clinical care and outcomes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Willing and able to give informed consent for participation in the study (translation needs for study information and forms for non-English speakers will be defined locally) OR Adults who otherwise lack the capacity to consent but for whom advice regarding participation has been obtained via a consultee using the personal or nominated consultee process
* Male or Female, aged 45 years and above
* Referred or referable with cognitive or behavioural symptoms and/or diagnosed with a cognition related disorder; including those with subjective cognitive impairment and functional disorders.
Exclusion Criteria
* Lack of venous access
* Unwilling to consent to NHS data linkage or in Northern Ireland, unwilling to allow long term follow up by access to electronic NHS records.
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Cambridge
OTHER
University of Edinburgh
OTHER
Greater Manchester Mental Health NHS Foundation Trust
OTHER
University of Bristol
OTHER
Queen Mary University of London
OTHER
West London NHS Trust
OTHER
University College, London
OTHER
Imperial College London
OTHER
Aneurin Bevan University Health Board
OTHER
Queen's University, Belfast
OTHER
University of Oxford
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vanessa Raymont
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Betsi Cadwaladr University Health Board
Bangor, , United Kingdom
ReMind UK
Bath, , United Kingdom
Belfast Health & Social Care Trust
Belfast, , United Kingdom
Dorset HealthCare University NHS Foundation Trust
Bournemouth, , United Kingdom
Berkshire Healthcare NHS Foundation Trust
Bracknell, , United Kingdom
Bradford District Care NHS Foundation Trust
Bradford, , United Kingdom
North Bristol NHS Trust
Bristol, , United Kingdom
Cambridgeshire and Peterborough NHS Foundation Trust
Cambridge, , United Kingdom
Devon Partnership NHS Trust
Exeter, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
East London NHS Foundation Trust
London, , United Kingdom
South London and Maudsley (SLaM)
London, , United Kingdom
St George's Hospital
London, , United Kingdom
West London NHS Trust
London, , United Kingdom
Greater Manchester Mental Health Foundation Trust
Manchester, , United Kingdom
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Aneurin Bevan University Health Board
Newport, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Oxford Health NHS Trust
Oxford, , United Kingdom
Lancashire & South Cumbria NHS Foundation Trust
Preston, , United Kingdom
Surrey and Borders Partnership NHS Foundation Trust
Redhill, , United Kingdom
Sheffield Health and Social Care NHS Foundation Trust
Sheffield, , United Kingdom
Sheffield Teaching Hospital
Sheffield, , United Kingdom
Hampshire and Isle of Wight NHS Foundation Trust
Southampton, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
Midlands Partnership University NHS Foundation Trust
Stafford, , United Kingdom
Sussex Partnership NHS Foundation Trust
Worthing, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ARUK-BBC2023-001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
24/WA/0330
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.