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Recruiting Not applicable

Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

NCT06598163 · tracked via the Priya Life Science France tracker
Sponsor
SharpTx
Phase
Not applicable
Started
2025-02-20
Last updated
2025-04-29

Condition(s) studied

Mild Cognitive Impairment

Investigational drug(s) / intervention(s)

Five Lives MED

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.

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Montreal Cognitive Assessment (MoCA) — 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.

Trial sites (7)

FacilityCityRegionStatus
Hôpital Broca, Service de gériatrie Hôpitaux Universitaire Paris Centre, Université Paris Cité Paris Île-de-France Region Not Yet Recruiting
Devon Partnership NHS Trust Exeter Devon Recruiting
Lancashire & South Cumbria NHS Foundation Trust Preston Lancashire Recruiting
Oxford University Hospitals NHS Foundation Trust Oxford Oxfordshire Active Not Recruiting
Somerset NHS Foundation Trust Taunton Somerset Recruiting
East London NHS Foundation Trust London United Kingdom Active Not Recruiting
South London & Maudsley NHS Foundation Trust London United Kingdom Active Not Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06598163 on ClinicalTrials.gov ↗ ← All trials in France