Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

Last updated: April 24, 2025
Sponsor: SharpTx
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Problems

Mild Cognitive Impairment

Mental Disability

Treatment

Five Lives MED

Clinical Study ID

NCT06598163
FLMED-01
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Mild Cognitive Impairment (also known as mild cognitive disorder [ICD-10-CM; G31.84] or mild neurocognitive disorder (DSM-5)

  • Age ≥ 50

  • Participant or informant is willing and able to give informed consent forparticipation in the study

  • Ability to read and understand English (UK) or French (France)

  • Access to a mobile phone (Apple iOS 12.4 or above or Android 6.0 (Marshmallow) orabove) or iPad (Apple iOS 12.4 or above only) with internet connection (mobile orWiFi).

Exclusion

Exclusion Criteria:

  • Diagnosis of dementia or evidence of functional impairment inconsistent with MCI

  • Severe visual impairment

  • Currently undergoing any other cognitive remediation programme

  • Currently taking part in any other investigational study that in the opinion of theinvestigator may impact the data integrity of the current study

  • Physical impairment that makes using a mobile device impossible

  • Lack of access to an informant

  • Participant under guardianship

  • Unwilling or unable to tolerate or engage with study procedures

  • Physical impairment that makes standing/walking unassisted impossible.

Study Design

Total Participants: 170
Treatment Group(s): 1
Primary Treatment: Five Lives MED
Phase:
Study Start date:
February 20, 2025
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Hôpital Broca, Service de gériatrie Hôpitaux Universitaire Paris Centre, Université Paris Cité

    Paris, Ile de France 75013
    France

    Site Not Available

  • Devon Partnership NHS Trust

    Exeter, Devon EX2 5AF
    United Kingdom

    Active - Recruiting

  • Lancashire & South Cumbria NHS Foundation Trust

    Preston, Lancashire PR5 6AW
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire OX3 9DU
    United Kingdom

    Site Not Available

  • Somerset NHS Foundation Trust

    Taunton, Somerset TA1 5DA
    United Kingdom

    Active - Recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, South Yorkshire S10 2RJ
    United Kingdom

    Site Not Available

  • East London NHS Foundation Trust

    London, E1 8DE
    United Kingdom

    Site Not Available

  • South London & Maudsley NHS Foundation Trust

    London, SE5 8AF
    United Kingdom

    Site Not Available

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