Multimodal METformin and FINGER lifestyle intervention to prevent cognitive impairment and disability in older adults at risk for dementia: a phase IIb multi-national randomised, controlled trial.

Conditions

Older adults with risk factors for dementia but dementia free and without substantial cognitive impairment. The intervention is aimed at preventing cognitive decline/dementia.

Brief summary

Composite z- score of an extended Neuropsychological Test Battery (NTB) adapted from the FINGER trial

Detailed description

Composite z-scores for NTB memory, executive function, and processing speed domains (based on FINGER), Clinical Dementia Rating Sum of Boxes, Instrumental Activities of Daily Living, Healthy Lifestyle Index, a composite score based on exercise, diet, lifestyle cardiovascular risk factors, and social and cognitive activity, BMI, waist, waist/hip ratio, blood pressure, lipid profile and glucose metabolism, Incident cardiovascular disease (e.g., myocardial infarction, angina pectoris, transient ischaemic attack, stroke, peripheral artery disease), FINGER healthy diet index, nutrients and food intake, Self-reported and objectively measured levels of physical activity, Short Physical Performance Battery, hand grip strength, and timed 10-meter dual-task test, Center for Epidemiological Studies-Depression Scale, Perceived Stress Scale, Insomnia Severity Index, RAND36 and 15D scales for health-related quality of life, Self-reported and register data for utilisation of healthcare resources

Related papers

No related papers found yet.

Interventions

DRUGThe placebo will be manufactured based on the Glucophage® XR 500 specifications to be identical to the IMP in all respects

DRUGexcept that for the lack of active substance.

DRUGMETFORMIN HYDROCHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Composite z- score of an extended Neuropsychological Test Battery (NTB) adapted from the FINGER trial	—

Secondary

Measure	Time frame
Composite z-scores for NTB memory, executive function, and processing speed domains (based on FINGER), Clinical Dementia Rating Sum of Boxes, Instrumental Activities of Daily Living, Healthy Lifestyle Index, a composite score based on exercise, diet, lifestyle cardiovascular risk factors, and social and cognitive activity, BMI, waist, waist/hip ratio, blood pressure, lipid profile and glucose metabolism, Incident cardiovascular disease (e.g., myocardial infarction, angina pectoris, transient ischaemic attack, stroke, peripheral artery disease), FINGER healthy diet index, nutrients and food intake, Self-reported and objectively measured levels of physical activity, Short Physical Performance Battery, hand grip strength, and timed 10-meter dual-task test, Center for Epidemiological Studies-Depression Scale, Perceived Stress Scale, Insomnia Severity Index, RAND36 and 15D scales for health-related quality of life, Self-reported and register data for utilisation of healthcare resources	—

Measure

Time frame

Composite z-scores for NTB memory, executive function, and processing speed domains (based on FINGER), Clinical Dementia Rating Sum of Boxes, Instrumental Activities of Daily Living, Healthy Lifestyle Index, a composite score based on exercise, diet, lifestyle cardiovascular risk factors, and social and cognitive activity, BMI, waist, waist/hip ratio, blood pressure, lipid profile and glucose metabolism, Incident cardiovascular disease (e.g., myocardial infarction, angina pectoris, transient ischaemic attack, stroke, peripheral artery disease), FINGER healthy diet index, nutrients and food intake, Self-reported and objectively measured levels of physical activity, Short Physical Performance Battery, hand grip strength, and timed 10-meter dual-task test, Center for Epidemiological Studies-Depression Scale, Perceived Stress Scale, Insomnia Severity Index, RAND36 and 15D scales for health-related quality of life, Self-reported and register data for utilisation of healthcare resources

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Countries

Finland, Sweden

Outcome results

None listed