Clinical investigation of the REACTIVE cognitive monitoring device

• Research type

  Research Study

• Full title

  Clinical Investigation to determine the accuracy of cognitive monitoring and feedback app, REACTIVE, to detect and predict cognitive decline in older adults

• IRAS ID

  349394

• Contact name

  Anne Corbett

• Contact email

  a.m.j.corbett@exeter.ac.uk

• Sponsor organisation

  University of Exeter

• Duration of Study in the UK

  3 years, 3 months, 1 days

• Research summary

  Mild cognitive impairment (MCI) affects about 10-20% of older adults, of whom 15% will develop dementia each year. Despite this, 99% of people with MCI are not in contact with healthcare services and wait until a crisis point before seeking help. There is currently no means of identifying these people in the community or any means of supporting them and their GP to manage their brain health and reduce their risk of dementia through evidence-based treatments.

  Computerised cognitive testing offers the potential for large-scale monitoring of cognition in the community. This would enable early detection, support and treatment of early cognitive impairment whilst driving efficiency and filling gaps in clinical pathways.
  REACTIVE is a combined technology that brings together cognitive monitoring and a digital platform with a track record for engagement of older adults. REACTIVE provides a user-friendly patient-facing app that can monitor brain health and identify people who are at risk of developing dementia. It can then alert primary care to trigger further assessment and diagnosis, thus providing a means of triaging patients into the dementia diagnostic pathway.

  This study will deliver a clinical investigation of the REACTIVE technology to establish its accuracy and sensitivity to identify individuals who are most likely to convert to MCI and dementia, and to align this process with blood biomarkers for Alzheimer’s Disease and neurodegeneration to increase the accuracy and power of the monitoring pathway. It will also establish the long-term acceptability of REACTIVE for both patients and clinicians. This study is required to provide key information for REACTIVE to progress through regulatory pathways towards approval as a Class IIa medical device.
  

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  25/YH/0076

• Date of REC Opinion

  10 Jun 2025

• REC opinion

  Further Information Favourable Opinion