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

Launched by IMPERIAL COLLEGE LONDON · Nov 4, 2021

Keywords

ClinConnect Summary

The MET-FINGER trial is studying whether a combination of healthy lifestyle changes and a diabetes medication called metformin can help prevent cognitive decline and dementia in older adults who are at risk. The goal is to see if this approach can improve thinking skills and overall health in people aged 60 to 79 who show some early signs of cognitive issues but do not have dementia. Participants will be divided into two groups: one will follow their own healthy lifestyle plan, while the other will receive more intensive support and guidance, including exercise, diet, brain training, and health checks. Some participants in the second group will also take metformin, and researchers will track their progress over two years.

To join the study, individuals must be between 60 and 79 years old, have certain cardiovascular risk factors, and show some cognitive decline based on specific tests. They should not have a diagnosis of dementia or significant cognitive impairment, and they must be able to communicate in English, Finnish, or Swedish. Throughout the study, participants will attend four assessment visits to monitor their health and cognitive function. This trial is important because it could lead to new ways to help older adults maintain their mental sharpness and independence as they age.

Gender

ALL

Eligibility criteria

• 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.