REAl World Dementia OUTcomes: Observational Study

NCT07238049 | Enrolling By Invitation

• 2 other identifiers: 24/WA/0330ARUK-BBC2023-001
• Study Type: observational
• Target: 3,165
• Locations: 1 country
• Sites: 27

Brief Summary

READ-OUT observational study will investigate blood-based biomarkers for dementia in real-world clinical settings. This 3-year observational study will include 3165 people, males or females aged 45 years or older, with cognitive impairment of any severity. 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.

Conditions

Alzheimer Disease (AD); Mild Cognitive Impairment (MCI); Dementia

Keywords

Dementia; Blood-based biomarkers; Diagnosis; Cognitive impairment; memory clinics

Outcome Measures

Primary Outcomes (3)

• Diagnostic accuracy of blood-based biomarkers for dementia diagnosis

  Accuracy, Positive and Negative predictive value in regard to diagnosis and, where available, gold standard biomarker measures (clinical consensus, cerebrospinal fluid, CSF, positron emission tomography, PET)

  baseline and at 52 weeks

• Feasibility and acceptability of blood-based biomarkers for dementia diagnosis

  Recruitment metrics at site level Acceptability patient questionnaires Patient and Public Involvement qualitative data around acceptability of BBM collection

  baseline, at 2 weeks and 52 weeks

• Cost-effectiveness of blood biomarkers in a real-world cognitive disorders population

  Health-related quality of life (HR-QoL) Healthcare utilisation

  baseline and at 52 weeks

Secondary Outcomes (6)

• Disease prediction utility of blood-based biomarkers in diverse cognitive disorders populations

  baseline and at 52 weeks

• Optimal individual or sets of biomarkers for separate dementia aetiologies

  baseline, at 2 weeks and 52 weeks

• Impact of sample processing delays on the accuracy of blood biomarkers

  Baseline study visit

• The test-retest reliability of blood biomarkers

  Baseline study visit, 1-2 week visit

• The utility of remote blood test kits

  Baseline study visit

Other Outcomes (1)

• Exploratory analysis to support development of novel multi-omics assays for dementia diagnosis and prognosis

  baseline and at 52 weeks

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People referred to, eligible for referral or already under review at primary and/or secondary memory assessment services (including memory clinics, brain health clinics) with some form of cognitive symptoms and/or cognitive disorders of any severity will be eligible for recruitment. Also, we recruit a subset of individuals who are not under a secondary care memory clinic but who have a clinical picture that would be suitable for secondary care assessment in memory clinic services.

You may qualify if:

• The participant may enter the study if ALL of the following apply:
• 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.

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• 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.

Sponsors & Collaborators

• University of Oxford: lead
• University of Cambridge: collaborator
• University of Edinburgh: collaborator
• Greater Manchester Mental Health NHS Foundation Trust: collaborator
• University of Bristol: collaborator
• Queen Mary University of London: collaborator
• West London NHS Trust: collaborator
• University College, London: collaborator
• Imperial College London: collaborator
• Aneurin Bevan University Health Board: collaborator
• Queen's University, Belfast: collaborator

Study Sites (27)

Betsi Cadwaladr University Health Board

Bangor, United Kingdom

Location

ReMind UK

Bath, United Kingdom

Location

Belfast Health & Social Care Trust

Belfast, United Kingdom

Location

Dorset HealthCare University NHS Foundation Trust

Bournemouth, United Kingdom

Location

Berkshire Healthcare NHS Foundation Trust

Bracknell, United Kingdom

Location

Bradford District Care NHS Foundation Trust

Bradford, United Kingdom

Location

North Bristol NHS Trust

Bristol, United Kingdom

Location

Cambridgeshire and Peterborough NHS Foundation Trust

Cambridge, United Kingdom

Location

Devon Partnership NHS Trust

Exeter, United Kingdom

Location

Barts Health NHS Trust

London, United Kingdom

Location

East London NHS Foundation Trust

London, United Kingdom

Location

South London and Maudsley (SLaM)

London, United Kingdom

Location

St George's Hospital

London, United Kingdom

Location

West London NHS Trust

London, United Kingdom

Location

Greater Manchester Mental Health Foundation Trust

Manchester, United Kingdom

Location

Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Location

Aneurin Bevan University Health Board

Newport, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Oxford Health NHS Trust

Oxford, United Kingdom

Location

Lancashire & South Cumbria NHS Foundation Trust

Preston, United Kingdom

Location

Surrey and Borders Partnership NHS Foundation Trust

Redhill, United Kingdom

Location

Sheffield Health and Social Care NHS Foundation Trust

Sheffield, United Kingdom

Location

Sheffield Teaching Hospital

Sheffield, United Kingdom

Location

Hampshire and Isle of Wight NHS Foundation Trust

Southampton, United Kingdom

Location

University Hospital Southampton

Southampton, United Kingdom

Location

Midlands Partnership University NHS Foundation Trust

Stafford, United Kingdom

Location

Sussex Partnership NHS Foundation Trust

Worthing, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (serum and plasma) will be retained for biomarker analysis and future research. DNA will be extracted for genotyping using whole genome enzymatic methylation sequencing with 30-50x coverage on Illumina NovaSeq X+. Cell-free DNA will be analysed using contemporary bioinformatics pipelines integrating multiple analytical approaches. Samples will be stored in the biorepository for exploratory biomarker development and future research with appropriate consent.

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia; Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vanessa Raymont

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 52 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: November 20, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: November 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (27)