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

Summary

Dementia is the main cause of disability in older adults, currently affecting about 50 million people world-wide with this number estimated to triple in the next 30 years. In MET-FINGER, we aim to understand whether the FINGER 2.0 multidomain intervention, combining healthy lifestyle changes and a drug for diabetes (metformin), may help reduce the risk of dementia and improve health and independence among older adults.

The study primary objective is to test the effect of the intervention, compared to healthy lifestyle advice, on the change in cognition, measured as a composite score including 14 of neuropsychological/cognitive tests. The secondary objective is to test the intervention effect on change in individual cognitive domains, functioning level, and risk factors for dementia (e.g., lifestyle, medical, and psychosocial). To this aim, a range of personal/health-related data and blood samples, will be collected. Potential interactions between metformin and lifestyle changes; potential disease-modifying effects; and feasibility of the metformin + lifestyle combination will be explored.

600 older people with risk factors for dementia, but without dementia/substantial cognitive impairment, will be recruited in the United Kingdom, Finland, and Sweden (at least 50% with higher genetic risk of Alzheimer's Disease/dementia based on the Apolipoprotein E (APOE) gene). Participants will be randomly assigned 1:1 to either a self-guided multidomain lifestyle intervention or to the FINGER 2.0 multidomain lifestyle-based intervention. Outcome assessors will be blinded to group allocation. Within the FINGER 2.0 intervention group, participants at increased risk of diabetes, will be randomly assigned 1:1:1 to either the metformin 2000mg/day, metformin 1000mg/day, or placebo group (double blinded). The intervention duration is 24 months.

The lifestyle intervention includes four main components: physical exercise, diet, brain training and health checks. In the self-guided group, participants will create their own program, based on health advice and recommendations which will be provided during the study. In the FINGER 2.0 intervention group, participants will receive intensive lifestyle guidance, and participate in structured activities, which will be as tailored as possible on each person's daily habits and needs.

Over the 2-year study period, all participants will attend four assessment visits: baseline, 6-, 12-, and 24-months.

Conditions

• Cognitive Decline
• Cognitive Impairment
• Dementia

Interventions

COMBINATION_PRODUCT

FINGER 2.0 multidomain lifestyle-based intervention

Multimodal lifestyle-based precision prevention intervention, including: * Optimized FINGER multidomain lifestyle intervention (diet, physical activity, cognitive training and cardiovascular/metabolic risk monitoring and social interaction) * Metformin (Glucophage® XR)

OTHER

Self-guided multidomain lifestyle intervention

Participants build their own healthy lifestyle program based on standard healthy lifestyle advice on diet, physical activity, cognitive training and cardiovascular/metabolic risk

Sponsors & Collaborators

• Alzheimer's Association

  collaborator OTHER

• Alzheimer's Drug Discovery Foundation

  collaborator OTHER

• Alzheimerfonden

  collaborator UNKNOWN

• Region Stockholm

  collaborator OTHER_GOV

• Merck KGaA, Darmstadt, Germany

  collaborator INDUSTRY

• Finnish Institute for Health and Welfare

  collaborator OTHER_GOV

• Fingers Brain Health Institute

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Imperial College London

  lead OTHER

Principal Investigators

• Tiia Ngandu, MD, PhD · Finnish Institute of Health and Welfare, Finland

• Francesca Mangialasche, MD, PhD · Karolinska Institutet

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-25

Primary Completion

2027-02-28

Completion

2027-06-28

Countries

• Finland
• Sweden
• United Kingdom

Study Locations