Actively Recruiting
METformin and FINGER Intervention to Prevent Cognitive Impairment and Disability in Older Adults at Risk for Dementia
Led by Imperial College London · Updated on 2024-02-06
600
Participants Needed
3
Research Sites
230 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
A
Alzheimer's Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
METformin and FINGER Intervention to Prevent Cognitive Impairment and Disability in Older Adults at Risk for Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60-79 years
- Cardiovascular Risk Factors, Aging and Dementia (CAIDE) Risk Score 6 points or higher
- Cognitive performance at or slightly below the average for age based on Montreal Cognitive Assessment (MoCA) and verbal learning tests
- Proficiency in the local language (English, Finnish, or Swedish)
- For metformin/placebo treatment: no diagnosed diabetes or contraindications to metformin
- For metformin/placebo treatment: Body Mass Index 25 kg/m2 or higher OR waist circumference over 102 cm in men and over 88 cm in women OR mildly impaired fasting glucose (6.1-6.9 mmol/l)
You will not qualify if you...
- Diagnosis of dementia or significant cognitive impairment requiring memory clinic referral
- Current or past use of Alzheimer's disease medications such as cholinesterase inhibitors, memantine, or aducanumab
- Unable to consent or complete study assessments due to diminished decision-making capacity
- Significant neurological diseases like Parkinson's, Huntington's, brain tumors, seizure disorders, or major head trauma with lasting effects
- Conditions that prevent safe participation, including malignant disease, major depression, symptomatic cardiovascular disease, or recent revascularization
- Severe loss of vision, hearing, or communication ability
- Participation in another intervention trial's active phase
- Household member already enrolled in this trial
- For metformin/placebo treatment: prior use or intolerance of metformin
- Diagnosed or suspected diabetes at baseline (e.g., HbA1c 6.5% or higher, fasting glucose 7 mmol/l or higher)
- Metformin contraindications such as kidney or liver disease, heart failure, alcohol abuse, or low kidney function (GFR below 60 ml/min)
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Finnish Institute of Health and Welfare - THL
Helsinki, Finland, FI-00271
Actively Recruiting
2
Karolinska Institutet
Solna, Sweden, 171 64
Actively Recruiting
3
Ageing Epidemiology Research Unit, Imperial College London
London, United Kingdom, W6 8RP
Actively Recruiting
Research Team
M
Miia Kivipelto, MD, PhD
CONTACT
A
Alina Solomon, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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