The efficacy of a digital health app Five Lives MED to improve cognitive function in patients with mild cognitive impairment: study protocol for a randomised controlled trial
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Background Mild cognitive impairment (MCI) is a prevalent neurocognitive disorder associated with an increased risk of progression to dementia. While pharmacological options remain limited and are not universally accessible, non-pharmacological interventions such as cognitive training and lifestyle modification show promise in slowing cognitive decline. Digitally delivered interventions offer advantages in scalability, accessibility, and personalisation, yet there is a lack of rigorously evaluated, multi-domain digital programmes for individuals with MCI. Five Lives MED is a novel digital motor-cognitive intervention combining computerised cognitive training, physical activity habit formation, and psychoeducation, delivered remotely via mobile devices. Methods This study is a single-blind, multicentre, randomised controlled trial conducted in the United Kingdom and France. A total of 170 participants aged 50 years or older with a clinical diagnosis of MCI will be randomised in a 1:1 ratio to either the intervention group or a control group receiving standard lifestyle advice. The intervention consists of a 12-week home-based programme delivered through the Five Lives MED app, incorporating daily motor-cognitive training sessions, goal-oriented physical activity tasks, and optional educational content. Outcome assessments will be conducted at baseline (T0), post-intervention at 12 weeks (T1), and at 6-month follow-up (T2). The primary outcome is change in global cognitive function measured by the Montreal Cognitive Assessment. Secondary outcomes include domain-specific cognitive performance, quality of life, dementia literacy, activities of daily living, behavioural symptoms, physical activity, and exploratory digital cognitive measures. Analyses will be conducted on an intention-to-treat basis, with additional per-protocol analyses where appropriate. Discussion This trial will be the first randomised controlled evaluation of Five Lives MED in individuals with MCI. By integrating cognitive training with physical activity and educational components in a fully remote format, the study aims to address key limitations of existing interventions related to accessibility and scalability. The findings will provide important evidence regarding the efficacy, feasibility, and clinical utility of a digital motor-cognitive intervention for MCI and will inform future implementation and larger-scale trials. Trial registration : ClinicalTrials.gov ID NCT06598163, first submitted on 2024-09-10, https://clinicaltrials.gov/study/NCT06598163?tab=study
