Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

NCT ID: NCT06598163

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2026-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Five Lives MED

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.

Group Type: EXPERIMENTAL

Five Lives MED

Intervention Type: 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.

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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SharpTx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivan Koychev, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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

Paris, Île-de-France Region, France

Site Status: NOT_YET_RECRUITING

Devon Partnership NHS Trust

Exeter, Devon, United Kingdom

Site Status: RECRUITING

Lancashire & South Cumbria NHS Foundation Trust

Preston, Lancashire, United Kingdom

Site Status: RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

Site Status: ACTIVE_NOT_RECRUITING

Somerset NHS Foundation Trust

Taunton, Somerset, United Kingdom

Site Status: RECRUITING

East London NHS Foundation Trust

London, , United Kingdom

Site Status: ACTIVE_NOT_RECRUITING

South London & Maudsley NHS Foundation Trust

London, , United Kingdom

Site Status: ACTIVE_NOT_RECRUITING

Countries

France; United Kingdom

Central Contacts

Jamie Kawadler, PhD

Role: CONTACT

jamie@fivelives.health

+447850104116

Philip Vassilev, PhD

Role: CONTACT

philip@fivelives.health

+33689397243

Facility Contacts

Murielle Pasquier

Role: primary

murielle.pasquier@aphp.fr

+33144083000

Ashley Wilkie, BSc

Role: primary

a.wilkie@nhs.net

+441392674117

Gayle Githens-Mazer, Master Clinical Research

Role: backup

gayle.githens-mazer@nhs.net

+441392674117

Beverley Lowe, BSc

Role: primary

beverley.lowe@lscft.nhs.uk

+441772773498

Farah Lunat, MSc

Role: backup

Farah.lunat@lscft.nhs.uk

+441772773498

Tracy Hallows, BSc

Role: primary

Research.mentalandcomm@somersetft.nhs.uk

+4401823343635

Flo Cullen

Role: backup

Flo.Cullen@somersetft.nhs.uk

+4401823343635

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Related Links

https://www.who.int/publications/i/item/9789240033245

World Health Organization. Global Status Report on the Public Health Response to Dementia. World Health Organization; 2021. 137 p.

Other Identifiers

FLMED-01

Identifier Type: -

Identifier Source: org_study_id