Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

April 24, 2025 updated by: SharpTx

Efficacy of a Digital Health App Five Lives MED to Improve Cognitive Function in Patients With Mild Cognitive Impairment: a Randomised Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75013
        • Not yet recruiting
        • Hôpital Broca, Service de gériatrie Hôpitaux Universitaire Paris Centre, Université Paris Cité
        • Contact:
        • Contact:
          • Olivier Hanon, MD
  • United Kingdom
      • London, United Kingdom, E1 8DE
        • Active, not recruiting
        • East London NHS Foundation Trust
      • London, United Kingdom, SE5 8AF
        • Active, not recruiting
        • South London & Maudsley NHS Foundation Trust
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5AF
        • Recruiting
        • Devon Partnership NHS Trust
        • Contact:
        • Contact:
        • Contact:
          • Chitra Srinivasan, MBBS, FRCPsych
    • Lancashire
      • Preston, Lancashire, United Kingdom, PR5 6AW
        • Recruiting
        • Lancashire & South Cumbria NHS Foundation Trust
        • Contact:
        • Contact:
        • Contact:
          • Salman Karim, MD
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Active, not recruiting
        • Oxford University Hospitals NHS Foundation Trust
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline and Study Exit (12 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mild Behavioural Impairment Checklist (MBI-C)
Time Frame: Baseline and Study Exit (12 weeks)
The Mild Behavioral Impairment Checklist (MBI-C) is a 34-item tool designed to detect the onset of neuropsychiatric symptoms that are significant and persistent, particularly in individuals who are at risk for developing dementia. The MBI-C assesses symptoms across five core domains: decreased motivation, affective dysregulation, impulse control, social inappropriateness, and abnormal perception or thought content. Each item in the checklist is rated based on whether the symptom has been present for at least six months, with severity ratings ranging from mild to severe.
Baseline and Study Exit (12 weeks)
Amsterdam IADL Questionnaire (A-IADL-Q-SV)
Time Frame: Baseline and Study Exit (12 weeks)

The Amsterdam Instrumental Activities of Daily Living Questionnaire - Short Version (A-IADL-Q-SV) is a concise, informant-based tool designed to assess impairments in instrumental activities of daily living (IADL) in individuals with cognitive decline, including those with dementia. The short version consists of 30 items, covering various daily activities such as household tasks, managing finances, using technology, and leisure activities.

The total score, or T-score, is normally distributed with a mean of 50 and a standard deviation of 10. The T-score range is approximately 20-80, with higher scores indicating better daily functioning
Baseline and Study Exit (12 weeks)
D-KEFS Trail Making Test
Time Frame: Baseline and Study Exit (12 weeks)
The Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test is a neuropsychological assessment used to evaluate various aspects of executive functioning, particularly cognitive flexibility, processing speed, and attention. It consists of five conditions that assess visual scanning, number sequencing, letter sequencing, number-letter switching, and motor speed. Each condition has raw and scaled scores, with higher scaled scores indicating better performance.
Baseline and Study Exit (12 weeks)
30-second Chair Stand test (30CST)
Time Frame: Baseline and Study Exit (12 weeks)
The 30-Second Chair Stand Test (30CST) is a functional fitness test designed to assess lower body strength and endurance, particularly in older adults. The test involves counting how many times an individual can fully stand up from a seated position and sit back down in a chair without using their arms, all within a 30-second period. A higher score indicates better performance. This test is commonly used to evaluate the risk of falls and overall functional mobility in seniors.
Baseline and Study Exit (12 weeks)
Five Lives cognitive tests
Time Frame: Baseline and Study Exit (12 weeks)

Five Lives offers five digital cognitive tests via iPad or smartphone, each targeting different cognitive functions.

  • the Snap test assesses verbal fluency,
  • the Breeze test measures short-term memory and numerical abilities through word recall tasks,
  • the Cast test evaluates spatial and numerical memory with increasingly complex grid tasks,
  • the Swift test, based on the Stroop Task, measures inhibition by requiring participants to identify the meaning or color of words, and
  • the Twist test assesses processing speed and cognitive control using a digitized version of the Trail Making Test.

Higher scores indicate better performance.
Baseline and Study Exit (12 weeks)
QoL in Alzheimer's disease (QOL-AD)
Time Frame: Baseline and Study Exit (12 weeks)
The Quality of Life in Alzheimer's Disease (QOL-AD) scale is a 13-item questionnaire designed to assess the quality of life of individuals diagnosed with Alzheimer's disease from both the patients and informants perspectives. It measures areas such as physical health, mood, relationships, and the ability to perform daily activities. Each item is rated on a 4-point scale from 1 (poor) to 4 (excellent), with total scores ranging from 13 to 52, where higher scores indicate a better perceived quality of life.
Baseline and Study Exit (12 weeks)
Alzheimer's Disease Knowledge Scale (ADKS)
Time Frame: Baseline and Study Exit (12 weeks)
The Alzheimer's Disease Knowledge Scale (ADKS) is a 30-item true/false questionnaire designed to assess knowledge about Alzheimers disease across several domains, including risk factors, symptoms, diagnosis, treatment, caregiving, and disease progression. Higher scores indicate better knowledge.
Baseline and Study Exit (12 weeks)
International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline and Study Exit (12 weeks)
The International Physical Activity Questionnaire (IPAQ) is a widely used self-report tool designed to measure physical activity levels. The IPAQ has been adapted for use with older adults, including those aged 65 and above. The IPAQ can be particularly useful in assessing physical activity levels in this demographic, helping to understand the frequency, intensity, and duration of various types of physical activity, such as walking, moderate, and vigorous activities. Scores will be expressed in metabolic equivalent (MET)-min per week, which higher MET-min indicating more physical activity.
Baseline and Study Exit (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SharpTx

Investigators

  • Principal Investigator: Ivan Koychev, MD, PhD, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLMED-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The anonymised IPD may be shared with other organisations and researchers, only if the participant has provided informed consent to do so and only if the data is used for other research that has passed ethical approval. Thus, the plan for IPD sharing is currently undecided as it remains to be determined if study audit will be conducted and if future studies will make use of the IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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