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Table 1 Eligibility criteria

From: A multimodal precision-prevention approach combining lifestyle intervention with metformin repurposing to prevent cognitive impairment and disability: the MET-FINGER randomised controlled trial protocol

Study eligibility criteria

Inclusion criteria

 1. Age 60–79 years

 2. CAIDE Dementia 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 MoCA test and the CERAD verbal learning test. This criterion is met if at least one of the following conditions is met:

  a) MoCA score ≤ 25 AND ≥ 15a

  b) CERAD immediate recall score ≤ 19

  c) CERAD delayed recall score ≤ 75% of the last immediate recall attempt

 4. Proficiency in the local language (English, Finnish or Swedish)

Exclusion criteriab

 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 AD or related diseases (e.g. cholinesterase inhibitors, memantine)

 3. Diminished decision-making capacity, not capable of consenting or completing study assessments, based on clinical judgement

 4. Other known significant neurologic diseases (including, e.g. Parkinson’s disease, Huntington’s disease, normal pressure hydrocephalus, brain tumour, progressive, supranuclear palsy, seizure disorder, subdural haematoma, 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

Metformin eligibility criteria

Inclusion criteria

 1. No diagnosed diabetes or known contraindications to metformin treatment.c

 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).d

Exclusion criteria

 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%d, fasting glucose ≥ 7 mmol/ld, or 2HPG ≥ 11.1 mmol/l)

 4. Hypersensitivity to metformin or to any of the excipients or placebo compounds

 5. Metformin contraindications, e.g. hepatic insufficiency and severe renal failure. Individuals with history/presence of known renal or liver disease, congestive heart failure, alcohol abuse, calculated GFR < 60 ml/mind will also be excluded from the study

 6. Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)

 7. Acute conditions with the potential to alter renal function such as dehydration, severe infection, and shock

 8. Disease which may cause tissue hypoxia (especially acute disease or worsening of chronic disease) such as decompensated heart failure, respiratory failure, recent myocardial infarction, and shock

 9. Women of childbearing potential

  1. 2HPG 2-h plasma glucose, AD Alzheimer’s disease, BMI body mass index, CAIDE Cardiovascular Risk Factors, Aging and Dementia, CERAD Consortium to Establish a Registry for Alzheimer’s Disease, GFR glomerular filtration rate, HbA1c haemoglobin A1c, MoCA Montreal Cognitive Assessment
  2. aMoCA was chosen over MMSE due to its higher sensitivity to subtle and early cognitive changes in older adults without dementia (Markwick, J Clin Exp Neuropsychol, 2012). The cut-offs were chosen to more accurately select a target population that excludes both high performers and people with substantial impairment including dementia
  3. bIndividually assessed by the study physician. Clinical assessment will provide a more accurate overall picture of the participant’s cognitive and functional level. If the need for memory clinic referral for further evaluation is identified based on clinical judgment, participants will be excluded irrespective of their MoCA or CERAD scores
  4. cThe process to determine eligibility for Metformin starts after the Randomisation 1 (Fig. 2) and it is structured in specific steps to minimise participant burden. The first step covers eligibility criteria assessed through baseline data (e.g. BMI, waist circumference, fasting glucose, diagnosis of diabetes, and relevant medical history). The second step is an additional screening visit in step-1 eligible participants (remaining eligibility and safety criteria, minus OGTT). Finally, OGTT is conducted in step 2 eligible participants
  5. dAssessed with baseline visit data
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Alzheimer's Research & Therapy

ISSN: 1758-9193