Enrolling by invitation

READ-OUTBlood-Based Biomarkers for Dementia Diagnosis in Diverse UK Memory Clinic Patients

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Study Aim

The study observes the accuracy, cost-effectiveness, and acceptability of blood-based biomarkers for diagnosing dementia in patients from diverse UK memory clinics.

What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Alzheimer Disease+11

+ Mental Disorders

+ Brain Diseases

Over 45 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: November 2024
See protocol details

Summary

Principal SponsorUniversity of Oxford
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2024

Actual date on which the first participant was enrolled.

Dementia is a growing concern in the UK, affecting more people and placing a burden on individuals and society. Accurate early diagnosis is crucial for timely intervention and care planning. The READ-OUT study focuses on testing blood-based biomarkers, which are indicators found in blood that can detect changes in the brain associated with dementia, particularly Alzheimer's disease. This research is important because it could offer a more accessible, less invasive, and cost-effective way to diagnose and predict dementia, compared to current methods that are not always available to all patients. Participants in the study, who come from diverse backgrounds and attend memory clinics across the UK, will provide a blood sample and answer questions about their quality of life and views on blood testing for dementia. The study will compare the accuracy of these blood tests against traditional diagnostic methods like clinical reviews and brain scans. Additionally, the study explores the reliability of repeated testing and the potential for patients to collect their own samples. The results aim to determine which blood tests are best for diagnosing dementia, their predictive ability, and their potential integration into the NHS, thus paving the way for better care and management of the disease.

Official TitleREAD-OUT - REAl World Dementia OUTcomes: Observational Study
NCT07238049
Principal SponsorUniversity of Oxford
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3165 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesCognition DisordersDementiaDiseaseNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurodegenerative DiseasesNeurocognitive DisordersTauopathiesCognitive Dysfunction

Criteria

3 inclusion criteria required to participate
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.

2 exclusion criteria prevent from participating
Unwilling to consent to NHS data linkage or in Northern Ireland, unwilling to allow long term follow up by access to electronic NHS records.

Lack of venous access

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 27 locations

Suspended

Betsi Cadwaladr University Health Board

Bangor, United KingdomOpen Betsi Cadwaladr University Health Board in Google Maps
Suspended

ReMind UK

Bath, United Kingdom
Suspended

Belfast Health & Social Care Trust

Belfast, United Kingdom
Suspended

Dorset HealthCare University NHS Foundation Trust

Bournemouth, United Kingdom
Enrolling by invitation27 Study Centers