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REAl world Dementia OUTcomes (READ-OUT) protocol: observational study
David J Whiteside1,2, Yi Yang3, Ahmet Begde3
1Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK djw216@cam.ac.uk.
BMJ Open
|June 25, 2026
Summary
This study assesses blood biomarkers for dementia in real-world UK populations. Findings will guide the integration of these biomarkers into clinical practice for better dementia diagnosis and care.
Area of Science:
- Neuroscience
- Biomarker Research
- Public Health
Background:
- Dementia diagnosis and prognosis require validated blood biomarkers (BBMs).
- Real-world data is crucial for integrating BBMs into clinical practice.
- Existing research highlights the need for studies on BBMs' societal implications.
Purpose of the Study:
- To evaluate the diagnostic and prognostic utility of BBMs in real-world dementia populations.
- To assess the societal and health economic implications of BBMs.
- To inform the design of a randomized controlled trial for BBM cost-effectiveness.
Main Methods:
- The REAl world Dementia OUTcomes (READ-OUT) study is a 3-year, multi-site observational study in the UK.
- 3165 participants aged 45+ attending memory assessment services are included, with up-sampling of under-represented groups.
- Data collection includes venepuncture, questionnaires, and linkage to electronic health records; substudies assess reliability and feasibility.
Main Results:
- The study protocol outlines the methodology for assessing BBMs' clinical utility against diagnoses and health records.
- Substudies will investigate BBM test-retest reliability and sample processing.
- Health economic data will be collected to assess BBMs' cost-effectiveness.
Conclusions:
- The READ-OUT study will provide essential evidence for the safe and effective integration of BBMs into dementia care.
- Findings will support the clinical utility and cost-effectiveness of using BBMs in memory assessment services.
- The study aims to improve dementia diagnosis and patient outcomes through biomarker research.
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