Dementia prevention breakthrough? metformin and lifestyle combo tested in major trial
NCT ID NCT05109169
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This trial tests whether combining a diabetes drug (metformin) with an intensive lifestyle program—including diet, exercise, brain training, and health monitoring—can prevent cognitive decline in older adults at risk for dementia. Six hundred participants aged 60-79 with risk factors but no dementia will be randomly assigned to either the combined intervention or standard health advice. The study lasts two years and measures changes in memory, thinking speed, and daily function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- metformin
- What this could lead to
- If successful, this could point toward a practical, drug-plus-lifestyle strategy to reduce dementia risk in older adults.
- What could go wrong
- This is a Phase 2 trial, so it is still early. The combination may not prove more effective than lifestyle advice alone, and metformin can cause gastrointestinal side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Main inclusion criteria (all participants) 1. Age 60-79 years. 2. Cardiovascular Risk Factors, Aging and Dementia (CAIDE) Risk Score ≥6 points. 3. Cognitive performance at the mean level or slightly lower than expected for age according to local population norms based on the Montreal Cognitive Assessment (MoCA) test and the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) verbal learning test. 4. Proficiency in the local language (English, Finnish or Swedish) * Inclusion criteria for metformin/placebo treatment (only for participants in the FINGER 2.0 multimodal lifestyle-based intervention arm) 1. No diagnosed diabetes or known contraindications to metformin treatment. 2. Elevated adiposity (BMI≥25 kg/m2 OR waist circumference \> 102 cm in men and \> 88 cm in women) OR mildly impaired fasting glucose (6.1-6.9 mmol/l). Exclusion Criteria: * Main exclusion criteria (all participants) 1. Dementia or substantial cognitive impairment (e.g., memory clinic referral needed as judged by the study physician). 2. Current or past use of medications for Alzheimer's Disease or related diseases (e.g., cholinesterase inhibitors, memantine, aducanumab). 3. Diminished decision-making capacity, not capable of consenting or completing study assessments, based on clinical judgement. 4. Other known significant neurologic disease (including e.g., Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumour, progressive, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities). 5. Any other condition affecting safe engagement in the intervention (e.g., malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within the previous year). 6. Severe loss of vision, hearing, or communicative ability; conditions preventing cooperation. 7. Coincident participation in the active phase of another intervention trial. 8. A member of the household already enrolled in the MET-FINGER trial * Exclusion criteria for metformin/placebo treatment (only for participants in the FINGER 2.0 multimodal lifestyle-based intervention group) 1. Use of metformin for any indication. 2. History of intolerance to metformin used for any indication. 3. Diabetes diagnosed or suspected at baseline (e.g., HbA1c≥6.5%, fasting glucose ≥7 mmol/l, or 2HPG≥11.1 mmol/l). 4. Metformin contraindications, e.g., history/presence of known renal or liver disease, congestive heart failure, alcohol abuse, calculated Glomerular Filtration Rate\<60 ml/min.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ageing Epidemiology Research Unit, Imperial College London
London, W6 8RP, United Kingdom
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Finnish Institute of Health and Welfare - THL
Helsinki, FI-00271, Finland
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Karolinska Institutet
Solna, 171 64, Sweden
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