Status:
RECRUITING
Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment
Lead Sponsor:
SharpTx
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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 quest...
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 acc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06598163
Start Date
February 20 2025
End Date
June 1 2026
Last Update
April 29 2025
Active Locations (7)
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1
Hôpital Broca, Service de gériatrie Hôpitaux Universitaire Paris Centre, Université Paris Cité
Paris, Île-de-France Region, France, 75013
2
Devon Partnership NHS Trust
Exeter, Devon, United Kingdom, EX2 5AF
3
Lancashire & South Cumbria NHS Foundation Trust
Preston, Lancashire, United Kingdom, PR5 6AW
4
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU