RecruitingPHASE2INTERVENTIONAL

METformin and FINGER Intervention to Prevent Cognitive Impairment and Disability in Older Adults at Risk for Dementia

This study, called MET-FINGER, is for older adults who are at risk of memory problems but don't have dementia yet. We want to see if a healthy lifestyle programme, sometimes combined with a common diabetes drug called metformin, can help protect their brains. Dementia affects many people worldwide, and this number is expected to grow. We're hoping this study will show ways to keep older adults independent and reduce their risk of memory decline. It involves different healthy lifestyle changes, like exercise, diet, and brain training, with some people also taking metformin or a dummy pill. The study will last for two years, following participants in the UK, Finland, and Sweden.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Imperial College London

Enrolment target

600

Start

25 Jan 2023

Estimated completion

28 Jun 2027

Cognitive Decline Cognitive Impairment Dementia

What is this study about?

Dementia is a serious condition that can cause significant disability in older people, affecting their memory, thinking, and daily life. Currently, millions of people worldwide are living with dementia, and this number is expected to rise. Because of this, researchers are urgently looking for ways to prevent or slow down its development.

This study, called MET-FINGER, is designed to investigate whether a specific healthy lifestyle programme, based on something called FINGER 2.0, combined with a commonly used diabetes medication called metformin, can help protect the brains of older adults. The FINGER 2.0 programme includes things like regular exercise, a healthy diet, brain training, and general health checks. We want to see if these efforts can reduce the risk of developing dementia and help people maintain their independence and overall health as they get older.

The study will involve 600 older adults who have some risk factors for dementia but do not yet have it. Some will follow a structured healthy lifestyle plan, and others will get general health advice. Some participants on the structured plan might also take metformin or a dummy pill. Over two years, we'll monitor changes in their thinking skills, daily functioning, and other health factors to understand the benefits of these interventions.

Key takeaways

This study aims to prevent memory problems and dementia in older adults.
It combines healthy lifestyle changes with a potential role for the diabetes drug metformin.
Participation involves following a lifestyle plan for two years, with regular assessments.
Researchers are looking for people aged 60-79 who have some dementia risk factors but not dementia itself.
The study includes exercise, diet advice, brain training, and health checks.

Who may be eligible?

This study is for people aged between 60 and 79 years old. You might be suitable if you have certain risk factors for heart and blood vessel problems, and your memory and thinking skills are either at an average level for your age or only slightly lower, but you do not have dementia.

If you're in the group that's trying the structured lifestyle changes, you might also be eligible for the metformin part of the study. This would be if you don't have diagnosed diabetes and don't have any medical reasons why you shouldn't take metformin. You would also need to have a higher body weight (based on BMI or waist size) or slightly higher-than-normal blood sugar levels (but not high enough for a diabetes diagnosis).

However, you cannot join the study if you already have dementia or severe memory problems, or if you're taking specific medications for Alzheimer's disease. You also can't take part if you have other serious brain conditions, certain severe medical conditions (like some cancers or severe heart disease), or significantly impaired sight, hearing, or communication that would make it hard to participate fully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 60 and 79 years old?
Do you have some risk factors for heart problems and dementia, but not dementia itself?
Are your memory and thinking skills average or only slightly lower for your age?
Do you speak English?
Do you NOT have diagnosed diabetes (for the metformin part of the study)?
Are you able to take part in regular exercise and health activities?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening appointment to check if you meet the study requirements. If you're eligible, you'll be invited for a baseline visit where you'll sign consent forms and have a full health check. You'll then be randomly placed into one of two main groups: either a structured FINGER 2.0 lifestyle programme or a self-guided lifestyle group, where you'll receive general health advice.

If you're in the FINGER 2.0 group and meet certain health criteria, you might then be randomly assigned to take either 2000mg of metformin, 1000mg of metformin, or a dummy pill (placebo) every day. Neither you nor the study team will know which you are taking. The FINGER 2.0 programme involves regular individual meetings and group sessions focusing on diet, exercise with a trainer, brain training (including online exercises), and monitoring your overall health.

The study will last for 24 months (two years). During this time, all participants will attend four assessment visits: at the beginning, after 6 months, after 12 months, and at the very end of the two years. These visits will involve various tests and checks to see how you're getting on.

Potential risks and benefits

Participating in this study might offer several potential benefits, such as receiving structured support for a healthier lifestyle, regular health monitoring, and the chance to contribute to important research on preventing dementia. However, like all studies, there could be some potential risks, such as side effects from metformin (if you receive it) or discomfort during assessments. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care. The study team will explain all potential benefits and risks in detail before you decide to join.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Finnish Institute of Health and Welfare - THL
Verified postcode
Helsinki, Finland· Recruiting
Karolinska Institutet
Verified postcode
Solna, Sweden· Recruiting
Ageing Epidemiology Research Unit, Imperial College London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'dementia risk factors'?

These are things that might make someone more likely to develop dementia, such as age, certain health conditions, or genetics.

What is metformin?

Metformin is a common medicine often used to treat type 2 diabetes. We are testing to see if it might also help with brain health.

What does 'multidomain lifestyle intervention' mean?

It means a healthy living programme that tackles several areas at once, like diet, exercise, and brain activities, rather than just one.

Will I know if I'm getting metformin or the dummy pill?

No, neither you nor the doctors will know, which helps to ensure the results are accurate. This is called 'double-blinded'.

How long will the study last for me?

If you join, your participation in the study will last for two years.

How to find out more

Miia Kivipelto, MD, PhD

miia.kivipelto@ki.se +46(0)739940922 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.