Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment
Recruiting now · Not applicable
Conditions studied: Mild Cognitive Impairment
In brief
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.
Key facts
- Study ID
- NCT06598163
- Run by
- SharpTx
- People needed
- 170
- Starts
- 2025-02-20
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-04-29
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Somerset NHS Foundation Trust — Taunton, Somerset, United Kingdom (enrolling)
- Lancashire & South Cumbria NHS Foundation Trust — Preston, Lancashire, United Kingdom (enrolling)
- Devon Partnership NHS Trust — Exeter, Devon, United Kingdom (enrolling)
- South London & Maudsley NHS Foundation Trust — London, United Kingdom
- Oxford University Hospitals NHS Foundation Trust — Oxford, Oxfordshire, United Kingdom
- Hôpital Broca, Service de gériatrie Hôpitaux Universitaire Paris Centre, Université Paris Cité — Paris, Île-de-France Region, France
- East London NHS Foundation Trust — London, United Kingdom
Full record on ClinicalTrials.gov
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