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Testing a digital app for thinking skills in mild cognitive impairment

Tests a digital app in people with mild cognitive impairment.

Key facts

Who runs it
SharpTx
Where
France and United Kingdom7 sites in 2 countriesChoose a country to see its sites
Trial code
Registry title
Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment
Status
Recruiting
People taking part
170 people, planned
Started
20 Feb 2025
Planned end
Jun 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Five Lives MED
Record updated
29 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 50 or over with mild cognitive impairment (MCI), a mild drop in memory or thinking. It tests whether the Five Lives MED phone app can improve thinking skills over 12 weeks.

Age
50 years and older
Sex
All sexes
Disease stage
Diagnosed mild cognitive impairment (mild cognitive disorder, ICD-10-CM G31.84, or mild neurocognitive disorder, DSM-5). People with dementia cannot join.
Earlier treatment
People currently in another cognitive remediation programme (brain-training treatment) cannot join.

Main reasons for not taking part

  • Diagnosis of dementia, or daily-life problems that go beyond MCI
  • Severe problems with eyesight
  • No informant (a person who knows you well and can give information)
  • Physical problems that make using a mobile device, or standing or walking without help, impossible
  • Being under guardianship, or in another study that may affect this study's data

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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 for participation 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) or above) or iPad (Apple iOS 12.4 or above only) with internet connection (mobile or WiFi)

Who cannot take part

  • Currently taking part in any other investigational study that in the opinion of the investigator may impact the data integrity of the current study
  • Diagnosis of dementia or evidence of functional impairment inconsistent with MCI
  • Severe visual impairment
  • Physical impairment that makes using a mobile device impossible
  • Physical impairment that makes standing/walking unassisted impossible
  • Currently undergoing any other cognitive remediation programme
  • Lack of access to an informant
  • Participant under guardianship
  • Unwilling or unable to tolerate or engage with study procedures

This trial has no sites in United States.

It has sites in 2 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Five Lives MEDTreatment being tested

    Participants will use the Five Lives MED app, where they will be offered \~30 min daily sessions including a healthy-habit-forming component and cognitive training. They will be able to complete maximum one session per day and will be advised to complete a minimum of 3 sessions per week. The participants can complete more sessions if they wish. After each session they have ad-libitum access to the cognitive-training games and educational articles.

  • ControlNo study treatment, for comparison

    Participants in the control group will receive an informational leaflet with up-to-date standard advice on sleep hygiene, diet, and physical exercise, with an explanation on how these relate to brain health.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy of a Digital Health App Five Lives MED to Improve Cognitive Function in Patients With Mild Cognitive Impairment: a Randomised Controlled Trial
Plain-language title
Testing a digital app for thinking skills in mild cognitive impairmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
29 April 2025