MET-FINGER
Research type
Research Study
Full title
Multimodal METformin and FINGER lifestyle intervention to prevent cognitive impairment and disability in older adults at risk for dementia: a phase IIb multi-national randomised, controlled trial.
IRAS ID
1004303
Contact name
Miia Kivipelto
Contact email
Sponsor organisation
Imperial College London, Research Governance and Integrity Team (RGIT)
Eudract number
2021-005213-14
Clinicaltrials.gov Identifier
Research summary
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 a combination of healthy lifestyle changes and a drug for diabetes (metformin) may help reduce the risk of dementia and improve health and independence among older adults.
600 healthy volunteers will be recruited in the UK, Finland, and Sweden (at least 50% with higher genetic risk based on the APOE gene). Volunteers will be randomly assigned in a 50-50 ratio to either a Self-guided (control/comparison) or a Structured (treatment) lifestyle programme. Within the structured group, volunteers at increased risk of diabetes, will be randomly assigned 1:1:1 to either the metformin 2000mg/day, metformin 1000mg/day, or placebo group. Neither the volunteers nor the researchers will know the metformin/placebo treatment group to which volunteers have been assigned.
The lifestyle programmes include four main components: physical exercise, diet, brain training and health checks. In the self-guided group, volunteers will create their own lifestyle programme, based on health advice and recommendations that will be provided during the study. In the structured lifestyle group, volunteers will receive more intensive lifestyle guidance, and participate in a programme involving structured activities, which will be as tailored as possible on each volunteer’s daily habits and needs.
Over the study period of 2 years, all participants will attend four assessment appointments: at the beginning of the study, at 6 and 12 months, and at the end of the study. These appointments will include memory tests, collection of personal and health-related information, physical/hearing/medical check-ups, collection of blood samples.
The study is funded by the Alzheimer’s Association - Part the Cloud Gates Partnership 2020 and the Alzheimer’s Drug Discovery Foundation.REC name
London - Westminster Research Ethics Committee
REC reference
22/LO/0053
Date of REC Opinion
2 Mar 2022
REC opinion
Further Information Favourable Opinion