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A multimodal precision-prevention approach combining lifestyle intervention with metformin repurposing to prevent cognitive impairment and disability: the MET-FINGER randomised controlled trial protocol
Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Yliopistonranta 1C, Kuopio, Finland; The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, London, United Kingdom.
Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Yliopistonranta 1C, Kuopio, Finland; Population Health Unit, Finnish Institute for Health and Welfare, Mannerheimintie 166, P.O. Box 30, Helsinki, Finland.
The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, London, United Kingdom; FINGERS Brain Health Institute, C/O Stockholms Sjukhem, Box 122 30, Stockholm, Sweden.
Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Karolinska Vägen 37A, Solna, Sweden; Theme Inflammation and Aging, Medical Unit Aging, Karolinska University Hospital, Karolinska Vägen 37A, Solna, Sweden.
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2024 (Engelska)Ingår i: Alzheimer's Research & Therapy, E-ISSN 1758-9193, Vol. 16, nr 1, artikel-id 23Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

Background: Combining multimodal lifestyle interventions and disease-modifying drugs (novel or repurposed) could provide novel precision approaches to prevent cognitive impairment. Metformin is a promising candidate in view of the well-established link between type 2 diabetes (T2D) and Alzheimer's Disease and emerging evidence of its potential neuro-protective effects (e.g. vascular, metabolic, anti-senescence). MET-FINGER aims to test a FINGER 2.0 multimodal intervention, combining an updated FINGER multidomain lifestyle intervention with metformin, where appropriate, in an APOE ε4-enriched population of older adults (60–79 years) at increased risk of dementia.

Methods: MET-FINGER is an international randomised, controlled, parallel-group, phase-IIb proof-of-concept clinical trial, where metformin is included through a trial-within-trial design. 600 participants will be recruited at three sites (UK, Finland, Sweden). Participants at increased risk of dementia based on vascular risk factors and cognitive screening, will be first randomised to the FINGER 2.0 intervention (lifestyle + metformin if eligible; active arm) or to receive regular health advice (control arm). Participants allocated to the FINGER 2.0 intervention group at risk indicators of T2D will be additionally randomised to receive metformin (2000 mg/day or 1000 mg/day) or placebo. The study duration is 2 years. The changes in global cognition (primary outcome, using a Neuropsychological Test Battery), memory, executive function, and processing speed cognitive domains; functional status; lifestyle, vascular, metabolic, and other dementia-related risk factors (secondary outcomes), will be compared between the FINGER 2.0 intervention and the control arm. The feasibility, potential interaction (between-groups differences in healthy lifestyle changes), and disease-modifying effects of the lifestyle-metformin combination will be exploratory outcomes. The lifestyle intervention is adapted from the original FINGER trial (diet, physical activity, cognitive training, monitoring of cardiovascular/metabolic risk factors, social interaction) to be consistently delivered in three countries. Metformin is administered as Glucophage®XR/SR 500, (500 mg oral tablets). The metformin/placebo treatment will be double blinded.

Conclusion: MET-FINGER is the first trial combining a multimodal lifestyle intervention with a putative repurposed disease-modifying drug for cognitive impairment prevention. Although preliminary, its findings will provide crucial information for innovative precision prevention strategies and form the basis for a larger phase-III trial design and future research in this field.

Trial registration: ClinicalTrials.gov (NCT05109169).

Ort, förlag, år, upplaga, sidor
BioMed Central (BMC), 2024. Vol. 16, nr 1, artikel-id 23
Nyckelord [en]
Alzheimer's, APOE, Cognitive impairment, Dementia prevention, Drug repurposing, Lifestyle intervention, Lifestyle-drug combination therapy, Metformin, World-Wide FINGERS
Nationell ämneskategori
Neurologi Endokrinologi och diabetes
Identifikatorer
URN: urn:nbn:se:umu:diva-220751DOI: 10.1186/s13195-023-01355-xISI: 001154328500002PubMedID: 38297399Scopus ID: 2-s2.0-85183664343OAI: oai:DiVA.org:umu-220751DiVA, id: diva2:1837082
Forskningsfinansiär
Karolinska InstitutetAlzheimerfondenRegion StockholmEU, Europeiska forskningsrådet, 804371EU, Horisont 2020VetenskapsrådetStiftelsen Stockholms SjukhemForte, Forskningsrådet för hälsa, arbetsliv och välfärdHjärnfondenFinlands AkademiNIH (National Institutes of Health), K24AG045334Tillgänglig från: 2024-02-12 Skapad: 2024-02-12 Senast uppdaterad: 2024-02-12Bibliografiskt granskad

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