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Mild Cognitive ImpairmentNCT06598163

Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

A study testing Five Lives MED in people with Mild Cognitive Impairment, run by SharpTx at 7 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Five Lives MED
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
7 sitesin 2 countries
Study dates
20 Feb 2025to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 9Show fewer
  • Participant under guardianship
  • Unwilling or unable to tolerate or engage with study procedures
  • Physical impairment that makes standing/walking unassisted impossible.

Trial locations and contacts

7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Jamie Kawadler, PhD contact

+447850104116

jamie@fivelives.health

Philip Vassilev, PhD contact

+33689397243

philip@fivelives.health

7 sites in 2 countries

United Kingdom6 sites, 3 recruiting

  • Devon Partnership NHS Trust

    Exeter, Devon, EX2 5AF

    Ashley Wilkie, BSc, +441392674117, a.wilkie@nhs.net

    Gayle Githens-Mazer, Master Clinical Research, +441392674117, gayle.githens-mazer@nhs.net

    Recruiting

  • East London NHS Foundation Trust

    London, E1 8DE

    Active, not recruiting

  • South London & Maudsley NHS Foundation Trust

    London, SE5 8AF

    Active, not recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire, OX3 9DU

    Active, not recruiting

  • Lancashire & South Cumbria NHS Foundation Trust

    Preston, Lancashire, PR5 6AW

    Beverley Lowe, BSc, +441772773498, beverley.lowe@lscft.nhs.uk

    Farah Lunat, MSc, +441772773498, Farah.lunat@lscft.nhs.uk

    Recruiting

  • Somerset NHS Foundation Trust

    Taunton, Somerset, TA1 5DA

    Tracy Hallows, BSc, +4401823343635, Research.mentalandcomm@somersetft.nhs.uk

    Flo Cullen, +4401823343635, Flo.Cullen@somersetft.nhs.uk

    Recruiting

Other trials in United Kingdom

France1 site, 1 recruiting

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

    Paris, Île-de-France Region, 75013

    Murielle Pasquier, +33144083000, murielle.pasquier@aphp.fr

    Olivier Hanon, MD

    Not yet recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Five Lives MED
Keywords
mild cognitive impairment, cognitive training, computerized cognitive training
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Five Lives MEDDevice

    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.

Study groups in NCT06598163
Study groupRoleWhat they receive
Five Lives MEDExperimentalParticipants 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.
Receives: Device: Five Lives MED
ControlNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Study Exit (12 weeks)

Secondary outcomes (8)

  1. Mild Behavioural Impairment Checklist (MBI-C)

    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.

    Measured: Baseline and Study Exit (12 weeks)

  2. Amsterdam IADL Questionnaire (A-IADL-Q-SV)

    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

    Measured: Baseline and Study Exit (12 weeks)

  3. D-KEFS Trail Making Test

    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.

    Measured: Baseline and Study Exit (12 weeks)

  4. 30-second Chair Stand test (30CST)

    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.

    Measured: Baseline and Study Exit (12 weeks)

  5. Five Lives cognitive tests

    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.

    Measured: Baseline and Study Exit (12 weeks)

  6. QoL in Alzheimer's disease (QOL-AD)

    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.

    Measured: Baseline and Study Exit (12 weeks)

  7. Alzheimer's Disease Knowledge Scale (ADKS)

    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.

    Measured: Baseline and Study Exit (12 weeks)

  8. International Physical Activity Questionnaire (IPAQ)

    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.

    Measured: Baseline and Study Exit (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start20 Feb 2025
  3. Primary completionApr 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06598163
Sponsor's protocol ID
FLMED-01
Status last verified
Apr 2025
First submitted
10 Sep 2024
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Publications

  • Gauthier S, Reisberg B, Zaudig M, Petersen RC, Ritchie K, Broich K, Belleville S, Brodaty H, Bennett D, Chertkow H, Cummings JL, de Leon M, Feldman H, Ganguli M, Hampel H, Scheltens P, Tierney MC, Whitehouse P, Winblad B; International Psychogeriatric Association Expert Conference on mild cognitive impairment. Mild cognitive impairment. Lancet. 2006 Apr 15;367(9518):1262-70. doi: 10.1016/S0140-6736(06)68542-5.

    PubMed 16631882

  • Petersen RC. Mild Cognitive Impairment. Continuum (Minneap Minn). 2016 Apr;22(2 Dementia):404-18. doi: 10.1212/CON.0000000000000313.

    PubMed 27042901

  • Jongsiriyanyong S, Limpawattana P. Mild Cognitive Impairment in Clinical Practice: A Review Article. Am J Alzheimers Dis Other Demen. 2018 Dec;33(8):500-507. doi: 10.1177/1533317518791401. Epub 2018 Aug 1.

    PubMed 30068225

  • Sachdev PS, Lipnicki DM, Kochan NA, Crawford JD, Thalamuthu A, Andrews G, Brayne C, Matthews FE, Stephan BC, Lipton RB, Katz MJ, Ritchie K, Carriere I, Ancelin ML, Lam LC, Wong CH, Fung AW, Guaita A, Vaccaro R, Davin A, Ganguli M, Dodge H, Hughes T, Anstey KJ, Cherbuin N, Butterworth P, Ng TP, Gao Q, Reppermund S, Brodaty H, Schupf N, Manly J, Stern Y, Lobo A, Lopez-Anton R, Santabarbara J; Cohort Studies of Memory in an International Consortium (COSMIC). The Prevalence of Mild Cognitive Impairment in Diverse Geographical and Ethnocultural Regions: The COSMIC Collaboration. PLoS One. 2015 Nov 5;10(11):e0142388. doi: 10.1371/journal.pone.0142388. eCollection 2015.

    PubMed 26539987

  • Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available.

    PubMed 28735855

  • Welstead M, Luciano M, Muniz-Terrera G, Taylor AM, Russ TC. Prevalence of Mild Cognitive Impairment in the Lothian Birth Cohort 1936. Alzheimer Dis Assoc Disord. 2021 Jul-Sep 01;35(3):230-236. doi: 10.1097/WAD.0000000000000433.

    PubMed 33480611

  • Gabelle A, Guery M, Doutriaux A, Bettayeb K. Forecasting the Prevalence of Alzheimer's Disease at Mild Cognitive Impairment and Mild Dementia Stages in France in 2022. J Prev Alzheimers Dis. 2023;10(2):259-266. doi: 10.14283/jpad.2023.22.

    PubMed 36946453

  • Vlachos GS, Kosmidis MH, Yannakoulia M, Dardiotis E, Hadjigeorgiou G, Sakka P, Ntanasi E, Stefanis L, Scarmeas N. Prevalence of Mild Cognitive Impairment in the Elderly Population in Greece: Results From the HELIAD Study. Alzheimer Dis Assoc Disord. 2020 Apr-Jun;34(2):156-162. doi: 10.1097/WAD.0000000000000361.

    PubMed 31913961

  • Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999 Mar;56(3):303-8. doi: 10.1001/archneur.56.3.303.

    PubMed 10190820

  • Tierney MC, Szalai JP, Snow WG, Fisher RH, Nores A, Nadon G, Dunn E, St George-Hyslop PH. Prediction of probable Alzheimer's disease in memory-impaired patients: A prospective longitudinal study. Neurology. 1996 Mar;46(3):661-5. doi: 10.1212/wnl.46.3.661.

    PubMed 8618663

  • Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.

    PubMed 25405755

  • Nguyen L, Murphy K, Andrews G. A Game a Day Keeps Cognitive Decline Away? A Systematic Review and Meta-Analysis of Commercially-Available Brain Training Programs in Healthy and Cognitively Impaired Older Adults. Neuropsychol Rev. 2022 Sep;32(3):601-630. doi: 10.1007/s11065-021-09515-2. Epub 2021 Jul 12.

    PubMed 34251578

  • Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

    PubMed 25771249

  • Hafdi M, Hoevenaar-Blom MP, Richard E. Multi-domain interventions for the prevention of dementia and cognitive decline. Cochrane Database Syst Rev. 2021 Nov 8;11(11):CD013572. doi: 10.1002/14651858.CD013572.pub2.

    PubMed 34748207

  • Kivipelto M, Mangialasche F, Ngandu T. Lifestyle interventions to prevent cognitive impairment, dementia and Alzheimer disease. Nat Rev Neurol. 2018 Nov;14(11):653-666. doi: 10.1038/s41582-018-0070-3.

    PubMed 30291317

Questions about this trial

What is this clinical trial studying?

A study testing Five Lives MED in people with Mild Cognitive Impairment, run by SharpTx at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jamie Kawadler, PhD (+447850104116, jamie@fivelives.health), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal Cognitive Assessment (MoCA) (time frame: Baseline and Study Exit (12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06598163, which also lists 57 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.

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Clinical Trial NCT06598163 | AzTrials