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Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: Mix of remote tasks and in-person visits
Drug or intervention: Five Lives MED (device)
How long the study runs: Study runs about 16 months (dates as stated)
About the drug or intervention: Five Lives MED — device: 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.
Patient visit burden: Not specified by the sponsor

In plain English

This study, run by the sponsor SharpTx, is testing whether a treatment called Five Lives MED can improve thinking and memory skills in people with Mild Cognitive Impairment (MCI). MCI means a person has memory or thinking problems that are worse than normal for their age but not severe enough to be called dementia. Participants need to use a mobile phone or iPad with an internet connection.

Who can take part

A diagnosis of Mild Cognitive Impairment (also called mild cognitive disorder or mild neurocognitive disorder)
Aged 50 or over
The participant or someone who knows them well can give informed agreement to take part
Able to read and understand English (UK) or French (France)
Access to a fairly recent mobile phone (Apple iOS 12.4 or above, or Android 6.0 or above) or iPad (iOS 12.4 or above) with an internet connection

Who may not be able to

A diagnosis of dementia, or everyday difficulties that do not fit with Mild Cognitive Impairment
Severe sight problems
Currently taking part in another programme to improve thinking and memory skills
Currently taking part in another research study that the study team thinks could affect this study's results
A physical problem that makes using a mobile device impossible
Not having someone who knows them well (an informant) who can help with the study
Being under guardianship
Being unwilling or unable to cope with or take part in the study procedures
A physical problem that makes standing or walking without help impossible

What taking part involves

• Using a mobile phone or iPad app called Five Lives MED
• Study procedures — details of what these involve: Not stated — ask the trial team

Time commitment: Not stated — ask the trial team (the study involves using a mobile device with internet, but the number of visits, how long the study lasts, and the time needed are not stated).

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 50 Years and over
Who: All
Number of participants: 170
Started: 2025-02-20
Last checked: 2025-04

Plain English Summary

What is this study?

• Testing a new treatment for mild cognitive impairment
• NA - 170 participants
• 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)

Who can take part?

• Ages 50 Years and over
• Diagnosed with mild cognitive impairment

Where?

• Exeter - Devon Partnership NHS Trust
• Preston - Lancashire & South Cumbria NHS Foundation Trust
• Oxford - Oxford University Hospitals NHS Foundation Trust
• Taunton - Somerset NHS Foundation Trust
• +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Mild Cognitive Impairment

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 50 Years and over
Who can join: All genders

What the study is looking for

✓Diagnosis of Mild Cognitive Impairment (also known as mild cognitive disorder \[ICD-10-CM; G31.84\] or mild...
✓Age ≥ 50
✓Participant or informant is willing and able to give agreement to take part 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...

Who cannot take part

✗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 the investigator may impact the data...
✗Physical impairment that makes using a mobile device impossible

See the full criteria

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 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). 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 the investigator 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.