At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- FINGER 2.0 multidomain lifestyle-based intervention (combination product), Self-guided multidomain lifestyle intervention (other)
- How long the study runs
- Study runs about 65 months (dates as stated)
- About the drug or intervention
- FINGER 2.0 multidomain lifestyle-based intervention — combination product: Multimodal lifestyle-based precision prevention intervention, including: * Optimized FINGER multidomain lifestyle intervention (diet, physical activity, cognitive training and cardiovascular/metabolic risk monitoring and social interaction) * Metformin (Glucophage® XR) · Self-guided multidomain lifestyle intervention — other: Participants build their own healthy lifestyle program based on standard healthy lifestyle advice on diet, physical activity, cognitive training and cardiovascular/metabolic risk
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 60 Years to 79 Years
- Who
- All
- Number of participants
- 600
- Started
- 2023-01-25
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for cognitive decline
- • Phase2 - 600 participants
- • Dementia is the main cause of disability in older adults, currently affecting about 50 million people world-wide with this number estimated to triple in the next 30 years
Who can take part?
- • Ages 60 Years to 79 Years
- • Diagnosed with cognitive decline
Where?
- • London - Ageing Epidemiology Research Unit, Imperial College London
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Dementia is the main cause of disability in older adults, currently affecting about 50 million people world-wide with this number estimated to triple in the next 30 years. In MET-FINGER, we aim to understand whether the FINGER 2.0 multidomain intervention, combining healthy lifestyle changes and a drug for diabetes (metformin), may help reduce the risk of dementia and improve health and independence among older adults. The study primary objective is to test the effect of the intervention, compared to healthy lifestyle advice, on the change in cognition, measured as a composite score including 14 of neuropsychological/cognitive tests. The secondary objective is to test the intervention effect on change in individual cognitive domains, functioning level, and risk factors for dementia (e.g., lifestyle, medical, and psychosocial). To this aim, a range of personal/health-related data and blood samples, will be collected. Potential interactions between metformin and lifestyle changes; potential disease-modifying effects; and feasibility of the metformin + lifestyle combination will be explored. 600 older people with risk factors for dementia, but without dementia/substantial cognitive impairment, will be recruited in the United Kingdom, Finland, and Sweden (at least 50% with higher genetic risk of Alzheimer's Disease/dementia based on the Apolipoprotein E (APOE) gene). Participants will be randomly assigned 1:1 to either a self-guided multidomain lifestyle intervention or to the FINGER 2.0 multidomain lifestyle-based intervention. Outcome assessors will be blinded to group allocation. Within the FINGER 2.0 intervention group, participants at increased risk of diabetes, will be randomly assigned 1:1:1 to either the metformin 2000mg/day, metformin 1000mg/day, or placebo group (double blinded). The intervention duration is 24 months. The lifestyle intervention includes four main components: physical exercise, diet, brain training and health checks. In the self-guided group, participants will create their own program, based on health advice and recommendations which will be provided during the study. In the FINGER 2.0 intervention group, participants will receive intensive lifestyle guidance, and participate in structured activities, which will be as tailored as possible on each person's daily habits and needs. Over the 2-year study period, all participants will attend four assessment visits: baseline, 6-, 12-, and 24-months.
More detail
After being identified and pre-screened in relevant registers, potential participants will undergo a screening assessment (after providing informed consent for the screening procedures) where inclusion criteria related to both cognition and cardiovascular/lifestyle risk factors will be checked. Participants meeting the inclusion criteria will undergo the exclusion criteria assessment with the study physician. Eligible participants will be invited to the baseline visit where informed consent for the full study will be signed, baseline assessment will be conducted, and participants will be randomized to either the FINGER 2.0 multidomain lifestyle-based intervention or self-guided multidomain lifestyle intervention group. Based on the results of the baseline assessment, the eligibility to the metformin/placebo treatment will be assessed in all participants randomized to the FINGER 2.0 intervention group. Eligible participants will be further randomized to one of the three metformin treatment groups (metformin 2000mg/day, metformin 1000mg/day, or placebo). Non eligible participants will continue the study by following the structured lifestyle intervention alone. In the self-guided intervention group, participants will build their own healthy lifestyle program based on standard healthy lifestyle advice that they will receive at individual consultations with the study physician/nurse as part of the visits. Within the FINGER 2.0 intervention group, participants will be invited to attend individual consultations and group meeting sessions in relation to the four intervention components (diet, physical activity, cognitive training, and cardiovascular/metabolic risk monitoring). As part of the physical activity component, group training sessions with a physiotherapist/professional trainer will be organized both at a gym as well as online. Within the cognitive training component, participants will have access to an online cognitive training program for independent training sessions. Individually tailored recommendations and plans will be provided to each participant. Metformin and placebo will be dispensed every 3 months, both administered orally. The active drug is Glucophage® XR 500. All participants randomized to the metformin/placebo groups will receive 4 identical tablets per day as follows: * 2000mg/day: 4x500mg metformin * 1000mg/day: 2x500mg metformin + 2x500mg placebo * Placebo: 4x500mg placebo. Metformin will be titrated weekly from 500mg/day up to 2000mg/day over 4 weeks. Participants who do not tolerate the treatment will be allowed to remain in the study either in a lower dose treatment group, or receiving the structured lifestyle intervention only. Participants will not be actively told to what lifestyle intervention group they have been assigned and assessors for primary and secondary outcomes will be blinded to the lifestyle group allocation. The metformin/placebo treatment will be conducted in double blind.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 60 Years - 79 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Main inclusion criteria (all participants)
- ✓Age 60-79 years.
- ✓Cardiovascular Risk Factors, Aging and Dementia (CAIDE) Risk Score ≥6 points.
- ✓Proficiency in the local language (English, Finnish or Swedish)
- ✓Inclusion criteria for metformin/placebo treatment (only for participants in the FINGER 2.0 multimodal...
Who cannot take part
- ✗Main exclusion criteria (all participants)
- ✗Dementia or substantial cognitive impairment (e.g., memory clinic referral needed as judged by the study physician).
- ✗Current or past use of medications for Alzheimer's Disease or related diseases (e.g., cholinesterase inhibitors,...
- ✗Diminished decision-making capacity, not capable of consenting or completing study assessments, based on clinical...
- ✗Any other condition affecting safe engagement in the intervention (e.g., malignant disease, major depression,...
See the full criteria
Where Is This Study? (1 UK site)
Ageing Epidemiology Research Unit, Imperial College London
London W6 8RP, United Kingdom