Using a digital health app to improve cognitive function in people with mild cognitive impairment
Efficacy of a Digital Health App Five Lives MED to Improve Cognitive Function in Patients With Mild Cognitive Impairment: a Randomised Controlled Trial
NA · SharpTx · NCT06598163
This study is testing whether using a digital health app can help improve thinking skills in people aged 50 and older with mild cognitive impairment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | SharpTx (industry) |
| Locations | 7 sites (Paris, Île-de-France Region and 6 other locations) |
| Trial ID | NCT06598163 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of the Five Lives MED digital health app in enhancing cognitive function among individuals diagnosed with mild cognitive impairment (MCI). Participants aged 50 and older will be randomly assigned to either the intervention group, which will use the app three times a week for 12 weeks, or a control group receiving standard health information. Cognitive testing and questionnaires will be administered at the beginning and end of the study to assess changes in cognitive function. The primary outcome measure will be the difference in MoCA scores between the two groups after the intervention period.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 and older who have been diagnosed with mild cognitive impairment.
Not a fit: Patients with a diagnosis of dementia or significant functional impairment, as well as those currently engaged in other cognitive remediation programs, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a non-pharmacological approach to improve cognitive function in patients with mild cognitive impairment.
How similar studies have performed: Other studies have shown promise with digital cognitive training interventions, suggesting that this approach may be effective, although the specific app being tested is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Paris, Île-de-France Region and 6 other locations
- Hôpital Broca, Service de gériatrie Hôpitaux Universitaire Paris Centre, Université Paris Cité — Paris, Île-de-France Region, France (NOT_YET_RECRUITING)
- Devon Partnership NHS Trust — Exeter, Devon, United Kingdom (RECRUITING)
- Lancashire & South Cumbria NHS Foundation Trust — Preston, Lancashire, United Kingdom (RECRUITING)
- Oxford University Hospitals NHS Foundation Trust — Oxford, Oxfordshire, United Kingdom (ACTIVE_NOT_RECRUITING)
- Somerset NHS Foundation Trust — Taunton, Somerset, United Kingdom (RECRUITING)
- East London NHS Foundation Trust — London, United Kingdom (ACTIVE_NOT_RECRUITING)
- South London & Maudsley NHS Foundation Trust — London, United Kingdom (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Ivan Koychev, MD, PhD — University of Oxford
- Study coordinator: Jamie Kawadler, PhD
- Email: jamie@fivelives.health
- Phone: +447850104116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mild Cognitive Impairment, mild cognitive impairment, cognitive training, computerized cognitive training