Clinical validation and commercialisation of the ReaCTIVE app: A proactive, interactive cognitive monitoring and intervention solution for people with early cognitive impairment
An app called ReaCTIVE asks older adults to play brain-training games on their phones, then uses the results to spot early signs of dementia. The problem is that people with mild cognitive impairment—a condition that raises dementia risk—are rarely diagnosed early and often receive no support. Current monitoring tools fail to keep patients engaged, so clinicians miss the window for precision medicine. ReaCTIVE combines a validated cognitive test (FLAME) with a training programme designed to hold users’ attention, packaging the data for clinicians to guide referrals and treatment decisions. If the trial succeeds, the app could become a Class IIa medical device used within the NHS. That would mean cheaper, more accessible cognitive monitoring for the 550 people with MCI and 952 older adults enrolled in this 36-month study. The team has already secured over £5 million in commercial contracts and plans to pursue CE marking and regulatory approval. This is applied clinical research with a clear commercial pathway. It does not explore fundamental mechanisms of dementia—it tests whether a specific digital tool works reliably in real-world settings and can be scaled for healthcare use.
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Research Questions Can an innovative cognitive monitoring app, ReaCTIVE, engage older adults and accurately detect cognitive decline and dementia? How can this technology be commercialised for UK healthcare usage? Background There is an urgent need to improve cognitive assessment, particularly in individuals experiencing early cognitive change. People with Age-Associated Cognitive Decline (AACD) and Mild Cognitive Impairment (MCI) are at increased risk of dementia, yet they are rarely diagnosed and often receive no support or treatment. Computerised cognitive assessment offers a means of identifying these individuals earlier, allowing clinicians to support them using precision medicine. A critical issue is to ensure patients engage with the monitoring tool, and this is an area where current technology is lacking. This study introduces ReaCTIVE, an app that combines a validated cognitive test system, FLAME, with a cognitive training programme with proven ability to engage users. Patient neuropsychological and health data collected on ReaCTIVE will be packaged for clinicians to support decision-making and referrals. It already has proven commercial success, having leveraged over £5million in commercial contracts, and our team brings experience of successfully launching computerised cognitive technology into the commercial space. Aims & Objectives This study seeks to: (i) Conduct a full clinical investigation to establish the sensitivity and specificity of ReaCTIVE to detect conversion from AACD/MCI to dementia; (ii) To establish concurrent validity of ReaCTIVE neuropsychological data with blood-based/neuroimaging biomarkers and traditional cognitive assessments; (iii) To define a risk prediction model based on these data; (iv) To establish the engagement and utility of ReaCTIVE in real-life settings; (v) To continue the commercialisation of ReaCTIVE and build an effective route to market. Methods An evaluation workstream will conduct a 36-month single-arm clinical investigation of ReaCTIVE in 952 adults over 65, including 550 people with MCI. The co-primary outcomes will be: (i) Sensitivity and specificity to detect patient converting from MCI to dementia, based on neuropsychological thresholds and adjudicated clinical review; (ii) Engagement and utility of ReaCTIVE based on usage data and user experience capture. Secondary outcomes will be concurrent validity with blood and neuroimaging biomarkers and independent neuropsychological assessments. A parallel clinical validity study will establish sensitivity to detect dementia in people with and without mild dementia. A separate workstream will focus on the design and commercialisation of ReaCTIVE, including extensive user engagement and co-design activity, a dedicated working group exploring the risks and benefits of ReaCTIVE and its implications for health economics, and a commercialisation work package that will progress the pipeline for regulatory approval as a Class IIa Medical Device and CE mark, and will build a robust commercialisation strategy that build on the current commercial profile of the FLAME component. Impact and dissemination ReaCTIVE offers an engaging, validated means of monitoring cognitive status, with the potential for better precision medicine, considerable cost savings and improvements to the patient experience. Dissemination activity will focus on launching the commercialisation strategy for market penetration into the NHS while delivering targeted communications across major stakeholder groups to maximise success.
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