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

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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

Barbera, Mariagnese (författare): Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Yliopistonranta 1C, 70211, Kuopio, Finland; The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, London, W6 8RP, UK,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

Lehtisalo, Jenni (författare): Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Yliopistonranta 1C, 70211, Kuopio, Finland; Population Health Unit, Finnish Institute for Health and Welfare, Mannerheimintie 166, P.O. Box 30, Helsinki, Finland

Perera, Dinithi (författare): The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, London, W6 8RP, UK; FINGERS Brain Health Institute, C/O Stockholms Sjukhem, Box 122 30, SE-102 26, Stockholm, Sweden,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

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Aspö, Malin (författare): Karolinska Institutet

Cross, Mary (författare): Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK,Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, Imperial College London, Stadium House, 68 Wood Lane, London, United Kingdom

De Jager Loots, Celeste A. (författare): The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, LondonLondon, W6 8RP, UK,The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, London, United Kingdom

Falaschetti, Emanuela (författare): Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK,Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, Imperial College London, Stadium House, 68 Wood Lane, London, United Kingdom

Friel, Naomi (författare): The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, LondonLondon, W6 8RP, UK,The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, London, United Kingdom

Luchsinger, José A. (författare): Departments of Medicine and Epidemiology, Columbia University Irving Medical Center, 622 W 168Th St, NY, New York, United States

Malmberg Gavelin, Hanna, 1982- (författare): Umeå universitet,Institutionen för psykologi,Department of Psychology, Umeå University, 901 87, Umeå, Sweden

Peltonen, Markku (författare): Population Health Unit, Finnish Institute for Health and Welfare, Mannerheimintie 166, P.O. Box 30, Helsinki, Finland; FINGERS Brain Health Institute, C/O Stockholms Sjukhem, Box 122 30, SE-102 26, Stockholm, Sweden

Price, Geraint (författare): The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, LondonLondon, W6 8RP, UK,The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, London, United Kingdom

Stigsdotter Neely, Anna, 1961- (författare): Karlstads universitet,Luleå tekniska universitet,Hälsa, medicin och rehabilitering,Department of Social and Psychological Studies, Karlstad University, Karlstad, Sweden; Department of Health, Education and Technology, Luleå University of Technology, 971 87, Luleå, Sweden,Institutionen för sociala och psykologiska studier (from 2013)

Thunborg, Charlotta (författare): Karolinska Institutet

Tuomilehto, Jaakko (författare): Population Health Unit, Finnish Institute for Health and Welfare, Mannerheimintie 166, P.O. Box 30, Helsinki, Finland; Department of Public Health, University of Helsinki, PO BOX 20, 00014, Helsinki, Finland; Diabetes Research Group, King Abdulaziz University, 21589, Jeddah, Saudi Arabia

Mangialasche, Francesca (författare): FINGERS Brain Health Institute, C/O Stockholms Sjukhem, Box 122 30, SE-102 26, Stockholm, Sweden; Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Karolinska Vägen 37A, 171 64, Solna, Sweden; Theme Inflammation and Aging, Medical Unit Aging, Karolinska University Hospital, Karolinska Vägen 37A, 171 76, Solna, Sweden

Middleton, Lefkos (författare): The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, LondonLondon, W6 8RP, UK; Directorate of Public Health, Imperial College NHS Healthcare Trust Hospitals, Praed Street, London, W2 1NY, UK,The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, London, United Kingdom; Directorate of Public Health, Imperial College NHS Healthcare Trust Hospitals, Praed Street, London, United Kingdom

Ngandu, Tiia (författare): Population Health Unit, Finnish Institute for Health and Welfare, Mannerheimintie 166, P.O. Box 30, Helsinki, Finland; Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Karolinska Vägen 37A, 171 64, Solna, Sweden

Solomon, Alina (författare): Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Yliopistonranta 1C, 70211, Kuopio, Finland; The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, London, W6 8RP, UK; Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Karolinska Vägen 37A, 171 64, Solna, Sweden,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; Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Karolinska Vägen 37A, Solna, Sweden

Kivipelto, Miia (författare): The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, LondonLondon, W6 8RP, UK; Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Karolinska Vägen 37A, 171 64, Solna, Sweden; Theme Inflammation and Aging, Medical Unit Aging, Karolinska University Hospital, Karolinska Vägen 37A, 171 76, Solna, Sweden; Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Yliopistonranta 1C, 70211, Kuopio, Finland,The Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, Charing Cross Hospital, St Dunstan’s Road, London, United Kingdom; 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; Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Yliopistonranta 1C, Kuopio, Finland

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BioMed Central Ltd, 2024
2024
Engelska.
Ingår i: Alzheimer's Research & Therapy. - : BioMed Central Ltd. - 1758-9193. ; 16

Relaterad länk:: https://doi.org/10.1...; visa fler...; https://ltu.diva-por... (primary) (Raw object); https://umu.diva-por... (primary) (Raw object); https://kau.diva-por... (primary) (Raw object); https://urn.kb.se/re...; https://doi.org/10.1...; https://urn.kb.se/re...; https://urn.kb.se/re...; http://kipublication...; visa färre...

Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

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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.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)

Nyckelord

Alzheimer’s
APOE
Cognitive impairment
Dementia prevention
Drug repurposing
Lifestyle intervention
Lifestyle-drug combination therapy
Metformin
World-Wide FINGERS
Psychology
Psykologi
Psykologi

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