Alzheimer Disease (AD)READ-OUTNCT07238049
REAl World Dementia OUTcomes: Observational Study
An observational study of Alzheimer Disease (AD) and Mild Cognitive Impairment (MCI), run by University of Oxford at 27 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Alzheimer Disease (AD), Mild Cognitive Impairment (MCI), Dementia
- How many people
- 3,165 participants
- Where
- 27 sitesUnited Kingdom
- Study dates
- 1 Nov 2024to 31 Oct 2029
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
United Kingdom27 sites
Betsi Cadwaladr University Health Board
Bangor
ReMind UK
Bath
Belfast Health & Social Care Trust
Belfast
Dorset HealthCare University NHS Foundation Trust
Bournemouth
Berkshire Healthcare NHS Foundation Trust
Bracknell
Bradford District Care NHS Foundation Trust
Bradford
North Bristol NHS Trust
Bristol
Cambridgeshire and Peterborough NHS Foundation Trust
Cambridge
Devon Partnership NHS Trust
Exeter
Barts Health NHS Trust
London
East London NHS Foundation Trust
London
South London and Maudsley (SLaM)
London
St George's Hospital
London
West London NHS Trust
London
Greater Manchester Mental Health Foundation Trust
Manchester
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Newcastle upon Tyne
Aneurin Bevan University Health Board
Newport
Nottingham University Hospitals NHS Trust
Nottingham
Oxford Health NHS Trust
Oxford
Lancashire & South Cumbria NHS Foundation Trust
Preston
Surrey and Borders Partnership NHS Foundation Trust
Redhill
Sheffield Health and Social Care NHS Foundation Trust
Sheffield
Sheffield Teaching Hospital
Sheffield
Hampshire and Isle of Wight NHS Foundation Trust
Southampton
University Hospital Southampton
Southampton
Midlands Partnership University NHS Foundation Trust
Stafford
Sussex Partnership NHS Foundation Trust
Worthing
About this study
Official title: READ-OUT - REAl World Dementia OUTcomes: Observational Study
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.
Read the detailed description
Dementia affects a growing number of people in the UK, with significant costs for individuals, families, and society. There is an urgent need for accurate diagnosis of dementia to allow early intervention and support when people can still make decisions about their care.
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.
- Keywords
- Dementia, Blood-based biomarkers, Diagnosis, Cognitive impairment, memory clinics
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: baseline and at 52 weeks
Secondary outcomes (6)
Disease prediction utility of blood-based biomarkers in diverse cognitive disorders populations
Cognitive score progression, MCI to dementia conversion, Institutionalisation, or Death, ethnicity.
Measured: baseline and at 52 weeks
Optimal individual or sets of biomarkers for separate dementia aetiologies
Accuracy, Positive and Negative predictive value in regard to subgroups of dementia diagnosis
Measured: baseline, at 2 weeks and 52 weeks
Impact of sample processing delays on the accuracy of blood biomarkers
BBM levels obtained from samples of varying degrees of processing delays
Measured: Baseline study visit
The test-retest reliability of blood biomarkers
BBM levels obtained from repeated sampling at baseline and after 1-2 week - a sub- study involving 10% of the participant sample.
Whether samples taken at different time points are comparable will be assessed
Measured: Baseline study visit, 1-2 week visit
The utility of remote blood test kits
Comparison of BBM levels obtained from phlebotomy and blood spot cards/Capillary Tubes involving 75 individuals within the sample; Accuracy, positive and negative predictive value for blood spot card/Capillary Tubes BBMs
Measured: Baseline study visit
Understanding participant preferences on disclosure of biomarker status in dementia diagnosis
Evaluation of participants' views on what information they wish to receive about their biomarker status, the preferred timing of disclosure, and the most appropriate method of communication. Quantitative data will be collected via questionnaires completed by all participants at baseline. A qualitative sub-study involving 15-20 participants, supported by the trial PPIE group, will explore experiences and preferences in greater depth through interviews and/or focus groups.
Measured: baseline and at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Nov 2024
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,165 participants (estimated)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, University of Edinburgh, Greater Manchester Mental Health NHS Foundation Trust, University of Bristol, Queen Mary University of London, West London NHS Trust, University College, London, Imperial College London, Aneurin Bevan University Health Board, Queen's University, Belfast
- Responsible party
- Sponsor
- Investigators
- Vanessa Raymont, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238049
- Sponsor's protocol ID
- 24/WA/0330
- Other IDs
- ARUK-BBC2023-001
- Acronym
- READ-OUT
- Status last verified
- Aug 2025
- First submitted
- 1 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised (linked) BBM and genetic data will be available for access (not copying/export) via the DPUK Data Portal (https://portal.dementiasplatform.uk/) upon an approved data/sample access proposal. It offers a secure, fully auditable data repository (currently facilitating access to data for over 3.6m individuals across more than 60 cohorts). A curated (standardised/harmonised) dataset will be made available to eligible researchers within the DPUK Trusted Research Environment (TRE) which is at the core of the Data Portal.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- READ-OUT - REAl World Dementia OUTcomes: Observational Study
- ClinicalTrials.gov ID
- NCT07238049
- Acronym / sponsor ID
- READ-OUT / 24/WA/0330
- Keywords
- Dementia, Blood-based biomarkers, Diagnosis, Cognitive impairment, memory clinics
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,165 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Cambridge, University of Edinburgh, Greater Manchester Mental Health NHS Foundation Trust, University of Bristol, Queen Mary University of London, West London NHS Trust, University College, London, Imperial College London, Aneurin Bevan University Health Board, Queen's University, Belfast
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dementia affects a growing number of people in the UK, with significant costs for individuals, families, and society. There is an urgent need for accurate diagnosis of dementia to allow early intervention and support when people can still make decisions about their care.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of blood-based biomarkers for dementia diagnosis
Time frame: baseline and at 52 weeks
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)
Feasibility and acceptability of blood-based biomarkers for dementia diagnosis
Time frame: baseline, at 2 weeks and 52 weeks
Recruitment metrics at site level Acceptability patient questionnaires Patient and Public Involvement qualitative data around acceptability of BBM collection
Cost-effectiveness of blood biomarkers in a real-world cognitive disorders population
Time frame: baseline and at 52 weeks
Health-related quality of life (HR-QoL) Healthcare utilisation
6 secondary outcomes
Disease prediction utility of blood-based biomarkers in diverse cognitive disorders populations
Time frame: baseline and at 52 weeks
Optimal individual or sets of biomarkers for separate dementia aetiologies
Time frame: baseline, at 2 weeks and 52 weeks
Impact of sample processing delays on the accuracy of blood biomarkers
Time frame: Baseline study visit
The test-retest reliability of blood biomarkers
Time frame: Baseline study visit, 1-2 week visit
The utility of remote blood test kits
Time frame: Baseline study visit
Understanding participant preferences on disclosure of biomarker status in dementia diagnosis
Time frame: baseline and at 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: Yes. Anonymised (linked) BBM and genetic data will be available for access (not copying/export) via the DPUK Data Portal (https://portal.dementiasplatform.uk/) upon an approved data/sample access proposal. It offers a secure, fully auditable data repository (currently facilitating access to data for over 3.6m individuals across more than 60 cohorts). A curated (standardised/harmonised) dataset will be made available to eligible researchers within the DPUK Trusted Research Environment (TRE) which is at the core of the Data Portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vanessa Raymont principal investigator
University of Oxford
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease (AD) and Mild Cognitive Impairment (MCI), run by University of Oxford at 27 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of blood-based biomarkers for dementia diagnosis (time frame: baseline and at 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.