Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

SharpTx

Status: Enrolling

Conditions: Mild Cognitive Impairment

Treatments: Device: Five Lives MED

Study type: Interventional

Funder types: Industry

Identifiers

NCT06598163

FLMED-01

Details and patient eligibility

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.

Full description

Mild cognitive impairment is a significant public health concern. Non-pharmacological interventions, specifically multi-domain lifestyle and computerised cognitive training interventions, offer an accessible, scalable, engaging and potentially effective solution to improve cognitive function.

Five Lives MED is an interventional digital health app consisting of a physical activity habit forming coaching programme and cognitive training exercises.

The purpose of this study is to evaluate the efficacy of the Five Lives MED device; the primary hypothesis is that there is a significant difference in MoCA scores between the intervention group and the control group after the 12-week Five Lives MED intervention, with an effect size of d = 0.50 or greater favouring the intervention group.

This is a multi-centre, randomised, single-blind, controlled study in participants aged ≥ 50 years with mild cognitive impairment. Participants will be randomly assigned to the intervention (Five Lives MED) or control group for a 12-week period on a 1:1 allocation ratio.

Enrollment: 170 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Five Lives MED

Experimental group

Description:

Participants will use the Five Lives MED app, where they will be offered \~30 min daily sessions including a healthy-habit-forming component and cognitive training. They will be able to complete maximum one session per day and will be advised to complete a minimum of 3 sessions per week. The participants can complete more sessions if they wish. After each session they have ad-libitum access to the cognitive-training games and educational articles.

Treatment:

Device: Five Lives MED

Control

No Intervention group

Description:

Participants in the control group will receive an informational leaflet with up-to-date standard advice on sleep hygiene, diet, and physical exercise, with an explanation on how these relate to brain health.