Table 2 Full schedule of outcomes assessments

Neuropsychological Test Battery (Primary outcome and secondary cognitive outcomes)

X

X

X

Clinical Dementia Rating Sum of Boxes (Study Partner required)

X

X

X

Activities of daily living

X

X

X

Healthy Lifestyle Index

X

X

X

Physical measurements (BMI, waist, waist/hip ratio, blood pressure)

X

X

X

X

Blood markers (lipid profile and glucose metabolism)

X

X

X

X

OGTT (only groups receiving metformin/placebo)

X

X

X

Incident cardiovascular disease

X

X

X

FINGER healthy diet index, nutrient and food intake

X

X

X

Levels of physical activity (self-reported and objectively measured)

X

X

X

Short Physical Performance Battery

X

X

Hand grip strength, and timed 10-m dual-task test

X

X

X

Center for Epidemiological Studies-Depression Scale

X

X

X

Perceived Stress Scale

X

X

X

Insomnia Severity Index

X

X

X

RAND36 and 15D scales for health-related quality of life

X

X

X

Self-reported data for utilisation of healthcare resources

X

X

X

Exploratory outcomes

Healthy lifestyle changes, e.g. exercise, diet, cardiovascular/metabolic factors and biomarkers, and cognitive activity

X

X

X

AD-related blood biomarkers

X

X

X

X

Neuroimaging (Planning phase)

X

X

Retention rate

Continuously during the study

Adherence to the SMLI and its individual components

Continuously during the study based on participation to the SMLI structured activities

Target metformin dose

Continuously during the study with compliance to treatment assessed at each dispensing appointment (every 3 months)