NCT06598163 Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment
| NCT ID | NCT06598163 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SharpTx |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2025-02-20 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Contact & Investigator
Ivan Koychev, MD, PhD
PRINCIPAL INVESTIGATOR
University of Oxford
Frequently Asked Questions
Who can join the NCT06598163 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06598163 currently recruiting?
Yes, NCT06598163 is actively recruiting participants. Contact the research team at jamie@fivelives.health for enrollment information.
Where is the NCT06598163 trial being conducted?
This trial is being conducted at Paris, France, Exeter, United Kingdom, Preston, United Kingdom, Oxford, United Kingdom and 3 additional locations.
Who is sponsoring the NCT06598163 clinical trial?
NCT06598163 is sponsored by SharpTx. The principal investigator is Ivan Koychev, MD, PhD at University of Oxford. The trial plans to enroll 170 participants.