RecruitingNAINTERVENTIONAL

Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

This research is testing whether a digital app, Five Lives MED, can help people with Mild Cognitive Impairment (MCI) improve their memory and thinking abilities. MCI means you might have some memory problems, but it's not as severe as dementia. We want to see if using this app for 12 weeks, three times a week at home, can make a difference. Some participants will use the app, and others will receive general health advice. At the start and end of the study, everyone will complete some tests and questionnaires to see how their thinking skills have changed. The insights from this study could help us find new ways to support people living with MCI.

At a glance

Status

Recruiting

Phase

Sponsor

SharpTx

Enrolment target

170

Start

20 Feb 2025

Estimated completion

01 Jun 2026

Mild Cognitive Impairment

What is this study about?

This study aims to discover if a special digital app, called Five Lives MED, can help people with Mild Cognitive Impairment (MCI) improve their thinking and memory skills. MCI means you might notice some changes in your memory or thinking, but it's not as serious as dementia and you can still manage your daily life. It's a common concern, and finding ways to support people with MCI is very important.

Non-drug approaches, especially those that combine lifestyle changes and brain training, could be a good way to help. The Five Lives MED app includes exercises to train your brain and coaching to help you build habits for physical activity. We want to see if using this app regularly can make a real difference in how well people think and remember things. If it works, it could offer an accessible and engaging way for many people to manage their MCI.

To find out, we'll compare two groups. One group will use the Five Lives MED app, and the other group will receive a leaflet with standard health information. Everyone in the study will have their thinking skills assessed at the beginning and end of the 12-week period. This will help us understand if the app leads to clear improvements in thinking abilities compared to simply receiving general health advice.

Key takeaways

This study explores a digital app for Mild Cognitive Impairment (MCI).
It aims to improve thinking skills, memory, and physical activity habits.
Participants will use an app or receive general health information for 12 weeks.
No medication is involved; the focus is on a non-drug intervention.
It could offer a new way to support people with MCI.
Your participation helps advance understanding of MCI treatments.

Who may be eligible?

This study is looking for people who have been diagnosed with Mild Cognitive Impairment (MCI). You should be aged 50 or older. You or someone who knows you well must be able to understand and agree to take part in the study. You also need to be able to read and understand English (if in the UK) or French (if in France).

To take part, you'll need access to a mobile phone (like an iPhone or Android phone) or an iPad with internet access. The device needs to be running a reasonably recent software version.

Unfortunately, you can't join the study if you have a diagnosis of dementia, or if your thinking difficulties are severe enough to significantly impact your daily life. We also can't include you if you have severe eyesight issues, are already doing another type of brain training programme, or are taking part in another medical study that might interfere with this one. If you have physical problems that make it hard to use a mobile device or stand/walk without help, or if you can't tolerate the study procedures, you won't be able to participate. We also need you to have someone (an 'informant') who can help provide information if needed.

Quick self-check

Are you aged 50 or over?
Have you been told you have Mild Cognitive Impairment (MCI)?
Do you have access to a smartphone or iPad with internet?
Can you read and understand English?
Are you able to use a mobile device and stand/walk without assistance?
Do you have someone who knows you well that can provide information if needed?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, it will last for 12 weeks. You'll be randomly put into one of two groups. One group will use the Five Lives MED app at home three times a week for 12 weeks. The other group will receive a leaflet with general health information.

At the very beginning of the study, and again after 12 weeks, you will have some thinking tests and fill out questionnaires. These assessments will help us understand how your thinking skills might have changed. All this will happen at home or at a convenient study centre. You won't be given any medication as part of this study.

Potential risks and benefits

Taking part in this study may offer various potential benefits. You might experience an improvement in your thinking skills by using the Five Lives MED app and following its guidance. Even if you are in the group receiving general health information, you will be helping to advance our understanding of Mild Cognitive Impairment. There are minimal risks involved, as the app is designed to be safe and engaging. However, using the app consistently might require some time commitment. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (7)

Hôpital Broca, Service de gériatrie Hôpitaux Universitaire Paris Centre, Université Paris Cité
Paris, France· Not yet recruiting
Devon Partnership NHS Trust
Exeter, United Kingdom· Recruiting
Lancashire & South Cumbria NHS Foundation Trust
Preston, United Kingdom· Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom· Active not recruiting
Somerset NHS Foundation Trust
Taunton, United Kingdom· Recruiting
East London NHS Foundation Trust
London, United Kingdom· Active not recruiting
South London & Maudsley NHS Foundation Trust
London, United Kingdom· Active not recruiting

Common questions

What is Mild Cognitive Impairment (MCI)?

MCI means you might have some changes in your memory or thinking, but they are not severe enough to affect your daily life as much as dementia would.

What is the Five Lives MED app?

It's a digital app designed to help with thinking skills. It includes brain training exercises and encourages physical activity.

How long does the study last?

The study lasts for 12 weeks.

Will I have to take any new medicines?

No, this study does not involve any medication. It focuses on using a digital app.

What will happen during the study?

You'll either use the Five Lives MED app or receive health advice, and you'll complete thinking tests and questionnaires at the start and end of the 12 weeks.

How to find out more

Jamie Kawadler, PhD

jamie@fivelives.health +447850104116 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.