Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

NCT06598163 | Recruiting

• 1 other identifier: FLMED-01
• Study Type: interventional
• Target: 170
• Locations: 2 countries
• Sites: 7

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.

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairment; cognitive training; computerized cognitive training

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment (MoCA)

  The pen and paper, full version of the Montreal Cognitive Assessment (MoCA) is a widely used screening tool designed to detect mild cognitive impairment (MCI) and early signs of dementia. It evaluates several cognitive domains, including short-term memory, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation to time and place. The MoCA is scored out of 30 points, with a score of 26 or above considered normal. Lower scores indicate potential cognitive impairment, with specific ranges often used to gauge the severity: 18-25 for mild cognitive impairment, 10-17 for moderate cognitive impairment, and below 10 for severe cognitive impairment.

  Baseline and Study Exit (12 weeks)

Secondary Outcomes (8)

• Mild Behavioural Impairment Checklist (MBI-C)

  Baseline and Study Exit (12 weeks)

• Amsterdam IADL Questionnaire (A-IADL-Q-SV)

  Baseline and Study Exit (12 weeks)

• D-KEFS Trail Making Test

  Baseline and Study Exit (12 weeks)

• 30-second Chair Stand test (30CST)

  Baseline and Study Exit (12 weeks)

• Five Lives cognitive tests

  Baseline and Study Exit (12 weeks)

Study Arms (2)

Five Lives MED

EXPERIMENTAL

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.

Device: Five Lives MED

Control

NO INTERVENTION

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.

Interventions

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. 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.

Five Lives MED

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• SharpTx: lead

Study Sites (7)

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

Paris, Île-de-France Region, 75013, France

NOT YET RECRUITING

Devon Partnership NHS Trust

Exeter, Devon, EX2 5AF, United Kingdom

RECRUITING

Lancashire & South Cumbria NHS Foundation Trust

Preston, Lancashire, PR5 6AW, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

ACTIVE NOT RECRUITING

Somerset NHS Foundation Trust

Taunton, Somerset, TA1 5DA, United Kingdom

RECRUITING

East London NHS Foundation Trust

London, E1 8DE, United Kingdom

ACTIVE NOT RECRUITING

South London & Maudsley NHS Foundation Trust

London, SE5 8AF, United Kingdom

ACTIVE NOT RECRUITING

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Related Links

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

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ivan Koychev, MD, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie Kawadler, PhD

CONTACT

+447850104116; jamie@fivelives.health

Philip Vassilev, PhD

CONTACT

+33689397243; philip@fivelives.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: February 20, 2025
• Primary Completion: April 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

GB (6); FR (1)