NCT06598163

Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

Efficacy of a Digital Health App Five Lives MED to Improve Cognitive Function in Patients With Mild Cognitive Impairment: a Randomised Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: SharpTx · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized controlled trial is to determine whether the digital health app Five Lives MED can improve cognitive function in people with mild cognitive impairment (MCI). The main question it aims to answer is: Can 12 weeks of using Five Lives MED improve global cognitive function in people diagnosed with MCI? Researchers will compare with a control group who receives a leaflet with standard health information. Participants in the intervention group will be asked to use the Five Lives MED app 3 times per week at home for 12 weeks. All participants, in both groups, will undergo cognitive testing and will complete questionnaires at baseline and exit.

Detailed description

Mild cognitive impairment is a significant public health concern. Non-pharmacological interventions, specifically multi-domain lifestyle and computerised cognitive training interventions, offer an accessible, scalable, engaging and potentially effective solution to improve cognitive function. Five Lives MED is an interventional digital health app consisting of a physical activity habit forming coaching programme and cognitive training exercises. The purpose of this study is to evaluate the efficacy of the Five Lives MED device; the primary hypothesis is that there is a significant difference in MoCA scores between the intervention group and the control group after the 12-week Five Lives MED intervention, with an effect size of d = 0.50 or greater favouring the intervention group. This is a multi-centre, randomised, single-blind, controlled study in participants aged ≥ 50 years with mild cognitive impairment. Participants will be randomly assigned to the intervention (Five Lives MED) or control group for a 12-week period on a 1:1 allocation ratio.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DEVICE	Five Lives MED	Five Lives MED is a mobile application that can be installed on smartphones and tablets using the Android and/or iOS operating systems for use at home. The app offers structured sessions that can be completed once per day. Once the session is completed, the app also offers optional access to additional cognitive training exercises and educational articles. The intervention sessions begins with a Habit Quest, a physical activity habit building tool delivered through a chat bot. Following the Habit Quest, the participant is guided through a series of gamified cognitive training exercises aimed at improving attention, memory, language and executive function.

Timeline

• Start date: 2025-02-20
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2024-09-19
• Last updated: 2025-04-29

Locations

7 sites across 2 countries: France, United Kingdom