FLAME Validation Study in Mild to Moderate Dementia (FLAG Study)
Research type
Research Study
Full title
Validation of the FLAME Cognitive Test System in people with mild to moderate dementia
IRAS ID
338077
Contact name
Anne Corbett
Contact email
Sponsor organisation
University of Exeter
ISRCTN Number
ISRCTN14836055
Duration of Study in the UK
0 years, 6 months, 29 days
Research summary
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. This represents a major challenge to health and social care. There are currently no disease-modifying treatments for dementia, although promising new drugs are being developed. These treatments will be most effective in people in the earlier stages of dementia so it is critical that these individuals can be identified accurately and monitored effectively in a scalable, affordable way. 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 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 is a 12 month research study. It aims to assess how the FLAME computerised cognitive test system compares with MoCA in people with mild to moderate dementia. This will provide valuable information whether the FLAME system compares to the gold standard MoCA tool for use in cognitive monitoring and assessment. MoCA is a pen-and-paper cognitive assessment delivered by a trained researcher.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
24/NW/0151
Date of REC Opinion
30 May 2024
REC opinion
Favourable Opinion