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Dementia prevention breakthrough? metformin and lifestyle combo tested in major trial

NCT ID NCT05109169

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

60 to 79 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Cognitive Dysfunction dementia prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ageing Epidemiology Research Unit, Imperial College London

    London, W6 8RP, United Kingdom

  • Finnish Institute of Health and Welfare - THL

    Helsinki, FI-00271, Finland

  • Karolinska Institutet

    Solna, 171 64, Sweden

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