BridgeMD
A clinical trial to test a combination of lifestyle-based intervention with metformin in preventing dementia.
EU CTIS ID: 2022-500438-27-01
What this study is testing
To test the effect of the 24-month FINGER 2.0 multimodal lifestyle-based intervention (structured multimodal intervention, active arm) versus a self-guided multimodal intervention (control / comparator arm) on change in cognition in an APOE ε4-enriched older population with increased dementia risk
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- For all: Age 60-79 years
- For all: CAIDE Dementia Risk Score ≥6 points
- For all: Cognitive performance at the mean level or slightly lower than expected for age according to local population norms based on the MoCA test and the CERAD verbal learning test.
- For all: Proficiency in the local language (English, Finnish or Swedish)
- For metformin/placebo group: No diagnosed diabetes or known contraindications to metformin treatment.
- For metformin/placebo group: 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).
You likely can't join if
- For all: Dementia or substantial cognitive impairment (e.g., memory clinic referral needed as judged by the study physician).
- For metformin/placebo group: History of intolerance to metformin used for any indication.
- For metformin/placebo group: Diabetes diagnosed or suspected at baseline (e.g., HbA1c≥6.5%, fasting glucose ≥7 mmol/l, or 2HPG≥11.1 mmol/l).
- For metformin/placebo group: Hypersensitivity to metformin or to any of the excipients or placebo compounds.
- For metformin/placebo group: Metformin contraindications, e.g., history/presence of known renal or liver disease, congestive heart failure, alcohol abuse, calculated GFR<60 ml/min.
- For metformin/placebo group: Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
See the full eligibility criteria
- For all: Age 60-79 years
- For all: CAIDE Dementia Risk Score ≥6 points
- For all: Cognitive performance at the mean level or slightly lower than expected for age according to local population norms based on the MoCA test and the CERAD verbal learning test.
- For all: Proficiency in the local language (English, Finnish or Swedish)
- For metformin/placebo group: No diagnosed diabetes or known contraindications to metformin treatment.
- For metformin/placebo group: 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).
- For all: Dementia or substantial cognitive impairment (e.g., memory clinic referral needed as judged by the study physician).
- For metformin/placebo group: History of intolerance to metformin used for any indication.
- For metformin/placebo group: Diabetes diagnosed or suspected at baseline (e.g., HbA1c≥6.5%, fasting glucose ≥7 mmol/l, or 2HPG≥11.1 mmol/l).
- For metformin/placebo group: Hypersensitivity to metformin or to any of the excipients or placebo compounds.
- For metformin/placebo group: Metformin contraindications, e.g., history/presence of known renal or liver disease, congestive heart failure, alcohol abuse, calculated GFR<60 ml/min.
- For metformin/placebo group: Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
- For metformin/placebo group: Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
- For metformin/placebo group: Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock.
- For metformin/placebo group: Women of childbearing potential (WOCBP)
- For all: Current or past use of medications for AD or related diseases (e.g., cholinesterase inhibitors, memantine, aducanumab).
- For all: Diminished decision-making capacity, not capable of consenting or completing study assessments, based on clinical judgement.
- For all: 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).
- For all: Any other condition affecting safe engagement in the intervention (e.g., malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within the previous year)
- For all: Severe loss of vision, hearing, or communicative ability; conditions preventing cooperation
- For all: Coincident participation in the active phase of another intervention trial.
- For all: A member of the household already enrolled in the MET-FINGER trial
- For metformin/placebo group: Use of metformin for any indication.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.