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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Arit Udoh
+44 (0)7857848118
a.udoh@exeter.ac.uk


Prof Anne Corbett
+44 (0)1392 72 4464
a.m.j.corbett@exeter.ac.uk


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Be Part of Research - Trial Details - Validation of the FLAME Cognitive Test System in people with mild to moderate dementia
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Validation of the FLAME Cognitive Test System in people with mild to moderate dementia

Recruiting

Open to: All Genders

Age: Mixed

Taunton Exeter Bodmin

Medical Conditions

People with mild to moderate Dementia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Over 850,000 people in the United Kingdom are diagnosed with dementia and this number is expected to rise to up to one million by the year 2040. Cognitive assessment is essential for the effective diagnosis and monitoring of the progression of dementia. Sensitive cognitive assessment tools are key to ensuring accurate, timely diagnosis and long-term monitoring of dementia, both in research and healthcare settings. Traditional cognitive assessment tools such as the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) are well-validated for the detection of dementia but are not well-suited for self-administration or scalable assessment using digital platforms. The FLAME cognitive assessment system is a self-administered computerised cognitive testing tool that can be used remotely with no need for clinician supervision. The system is online and can be completed on an app or website. The FLAME cognitive assessment system has already been validated in a group of 25,000 people aged over 50 enrolled in the PROTECT-UK ageing cohort study, but it has not yet been tested in people with dementia. The FLAME validation study (FLAG) is a 12-month research study that aims to assess how the FLAME computerised cognitive test system compares with MoCA in people with mild to moderate dementia. MoCA is a pen-and-paper cognitive assessment delivered by a trained researcher. The FLAG study will provide valuable information on whether the FLAME system compares to the gold standard MoCA tool for use in cognitive monitoring and assessment.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

02 Sep 2024 31 Mar 2025

Potential participants will be asked to nominate a study partner or carer to participate with them. Participants and their caregivers will be approached by telephone, email and/or SMS and invited to attend a research clinic at the GP surgery or memory clinic. Upon consent, participants will complete the MoCA and FLAME test system. They will be asked to provide a finger prick and venous blood sample and complete a study questionnaire. After providing consent, the study partner will be asked to complete two questionnaires. All study procedures will be completed on the same day.


Participants aged 60 – 90 years old who have been diagnosed with mild to moderate dementia (MoCA score 15-26 inclusive or ACE score 70-90 inclusive).

You can take part if:



You may not be able to take part if:


1. Visual impairment that prevents completion of computer-based tasks2. Diagnosis of Parkinson’s Disease or stroke affecting the upper limbs or any physical disability impairing the use of computer keys or touchscreen3. Moderate or severe learning disability


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Musgrove Park Hospital (taunton)
    Musgrove Park Hospital
    Taunton
    TA1 5DA
  • Devon Partnership NHS Trust
    Wonford House Hospital Dryden Road
    Exeter
    EX2 5AF
  • Cornwall Partnership NHS Foundation Trust
    Carew House Beacon Technology Park Dunmere Road
    Bodmin
    PL31 2QN

Taking part in this study could help move the understanding of how to detect dementia earlier forward. FLAME could be used by people at home to monitor brain health and find people who need to be diagnosed and treated. The FLAME tests are difficult and it can take up to 40 minutes to complete. There is a risk of feeling tired or upset by the tests. The researcher will be available to explain the tests to the participants so they know what to expect. There is a risk of pain or discomfort from blood sampling. People often experience bruising and low levels of pain during and after giving a blood sample. These will be checked by a researcher and you can let us know about any other issues.

Prof Anne Corbett
+44 (0)1392 72 4464
a.m.j.corbett@exeter.ac.uk


Dr Arit Udoh
+44 (0)7857848118
a.udoh@exeter.ac.uk



The study is sponsored by University of Exeter and funded by National Institute for Health and Care Research.



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Read full details for Trial ID: ISRCTN14836055

Or CPMS 62561

Last updated 21 January 2025

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