Not recruiting

Study on Metformin and Lifestyle Changes to Prevent Dementia in Older Adults at Risk

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on preventing cognitive decline and dementia in older adults who are at risk but currently do not have dementia or significant memory problems. The study will use a combination of a lifestyle-based program and a medication called Metformin Hydrochloride. Metformin is commonly used to help control blood sugar levels in people with diabetes, but in this study, it is being tested for its potential benefits in preventing dementia.

The purpose of the study is to see if a structured lifestyle program combined with Metformin can help maintain or improve cognitive function in older adults. Participants will be randomly assigned to either an active group receiving the structured lifestyle program and Metformin or a control group receiving a self-guided lifestyle program and a placebo. The lifestyle program includes guidance on diet, exercise, and other healthy habits. The study will last for 24 months, during which participants will be monitored for changes in their cognitive abilities and overall health.

Throughout the study, various aspects of health will be assessed, including memory, thinking skills, physical activity, diet, and quality of life. The trial aims to provide valuable insights into whether combining lifestyle changes with Metformin can effectively reduce the risk of developing dementia in older adults. Participants will be closely monitored to ensure their safety and well-being throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the study, participants will be randomly assigned to one of two groups. One group will receive a lifestyle-based intervention combined with metformin, while the other group will receive a self-guided lifestyle intervention with a placebo.
The purpose of this trial is to test the effect of these interventions on preventing cognitive decline in older adults at risk for dementia.
Step 2
Medication administration
Participants in the metformin group will take metformin hydrochloride orally. The dosage and frequency will be determined by the study team and will be based on individual needs and health status.
Participants in the placebo group will take a pill that looks identical to the metformin pill but does not contain the active substance.
Step 3
Lifestyle intervention
The lifestyle intervention will include guidance on exercise, diet, and other healthy habits. Participants will receive structured support or self-guided materials depending on their group assignment.
The intervention aims to improve overall health and reduce the risk of cognitive decline.
Step 4
Regular assessments
Throughout the 24-month trial, participants will undergo regular assessments to monitor cognitive function and overall health.
These assessments will include tests of memory, executive function, and processing speed, as well as evaluations of physical health and lifestyle factors.
Step 5
End of the trial
At the end of the trial, participants will have a final assessment to evaluate the effects of the intervention on cognitive function and health.
The results will contribute to understanding how lifestyle changes and metformin can help prevent dementia in at-risk populations.

Who can join the trial?

6 criteria

Age between 60-79 years.
A CAIDE Dementia Risk Score of 6 points or more. This is a score that helps estimate the risk of developing dementia.
Cognitive performance that is at the average level or slightly lower than expected for your age. This is measured using tests like the MoCA (Montreal Cognitive Assessment) and the CERAD verbal learning test.
Ability to speak and understand the local language, which can be English, Finnish, or Swedish.
If you are in the metformin/placebo group, you should not have diagnosed diabetes or any known reasons why you should not take metformin.
If you are in the metformin/placebo group, you should have either elevated adiposity (which means a BMI of 25 or more or a waist circumference greater than 102 cm for men and 88 cm for women) or mildly impaired fasting glucose (a blood sugar level between 6.1-6.9 mmol/l).

Who cannot join the trial?

4 criteria

Individuals who already have **dementia** or significant memory and thinking problems cannot participate.
Participants must be older adults who are at risk for dementia but do not currently have it.
Both **men** and **women** can participate.
Participants should not belong to a **vulnerable population**, which means groups that might need special protection or care.

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Verified sites

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Verified
Finnish Institute For Health And Welfare
Helsinki, Finland
Verified
Karolinska University Hospital
Solna, Sweden

Trial locations

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Investigated drugs

METformin
is a medication commonly used to help control blood sugar levels in people with type 2 diabetes. In this clinical trial, it is being studied for its potential benefits in preventing cognitive decline and disability in older adults who are at risk for dementia. Researchers are interested in seeing if METformin can help improve brain health and slow down memory problems in these individuals.
FINGER lifestyle intervention
is a structured program designed to promote healthy living through various activities and habits. This intervention includes guidance on diet, physical exercise, cognitive training, and managing heart health. The goal is to help older adults at risk for dementia maintain their cognitive abilities and overall well-being. Participants in the trial will follow this lifestyle program to see if it can effectively prevent or slow down cognitive decline.

Metformin Hydrochloride

What is already known about the treatment

Metformin – Metformin is typically administered orally in the form of tablets. It is a well-established medication primarily used to manage type 2 diabetes by helping to control blood sugar levels. In the context of this clinical trial, Metformin is being investigated for its potential to prevent cognitive decline and dementia in older adults who are at risk but currently free from significant cognitive impairment. The medication works by improving the body's sensitivity to insulin and reducing glucose production in the liver, which may have beneficial effects on brain health. Metformin is classified as a biguanide, a type of drug that helps lower blood sugar levels.

Investigated diseases

Cognitive Decline – Cognitive decline refers to the gradual loss of cognitive abilities, including memory, thinking, and reasoning skills. It often begins with mild forgetfulness and can progress to more significant memory problems and difficulties in concentrating or making decisions. As it advances, individuals may struggle with language, lose track of time, and have trouble recognizing familiar people or places. The progression can vary widely among individuals, with some experiencing a slow decline and others facing more rapid changes. Cognitive decline is often associated with aging but can also be influenced by lifestyle factors and underlying health conditions. It is a key feature in conditions like dementia but can occur independently in older adults.