Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT06598163

Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

Led by SharpTx · Updated on 2025-04-29

170

Participants Needed

7

Research Sites

66 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of mild cognitive impairment (also known as mild cognitive disorder or mild neurocognitive disorder)
  • Age 50 years or older
  • Participant or informant willing and able to give informed consent to participate
  • 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 or above) or iPad (Apple iOS 12.4 or above) with internet connection
Not Eligible

You will not qualify if you...

  • Diagnosis of dementia or functional impairment inconsistent with mild cognitive impairment
  • Severe visual impairment
  • Currently undergoing any other cognitive remediation program
  • Currently participating in another investigational study that may affect data integrity
  • 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 or walking unassisted impossible

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

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

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

Not Yet Recruiting

2

Devon Partnership NHS Trust

Exeter, Devon, United Kingdom, EX2 5AF

Actively Recruiting

3

Lancashire & South Cumbria NHS Foundation Trust

Preston, Lancashire, United Kingdom, PR5 6AW

Actively Recruiting

4

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom, OX3 9DU

Active, Not Recruiting

5

Somerset NHS Foundation Trust

Taunton, Somerset, United Kingdom, TA1 5DA

Actively Recruiting

6

East London NHS Foundation Trust

London, United Kingdom, E1 8DE

Active, Not Recruiting

7

South London & Maudsley NHS Foundation Trust

London, United Kingdom, SE5 8AF

Active, Not Recruiting

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Research Team

J

Jamie Kawadler, PhD

CONTACT

P

Philip Vassilev, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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