title: A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial.
abstract: BACKGROUND
  Modifiable vascular and lifestyle-related risk factors have been associated with dementia risk in observational studies. In the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), a proof-of-concept randomised controlled trial, we aimed to assess a multidomain approach to prevent cognitive decline in at-risk elderly people from the general population.
  
  
  METHODS
  In a double-blind randomised controlled trial we enrolled individuals aged 60-77 years recruited from previous national surveys. Inclusion criteria were CAIDE (Cardiovascular Risk Factors, Aging and Dementia) Dementia Risk Score of at least 6 points and cognition at mean level or slightly lower than expected for age. We randomly assigned participants in a 1:1 ratio to a 2 year multidomain intervention (diet, exercise, cognitive training, vascular risk monitoring), or a control group (general health advice). Computer-generated allocation was done in blocks of four (two individuals randomly allocated to each group) at each site. Group allocation was not actively disclosed to participants and outcome assessors were masked to group allocation. The primary outcome was change in cognition as measured through comprehensive neuropsychological test battery (NTB) Z score. Analysis was by modified intention to treat (all participants with at least one post-baseline observation). This trial is registered at ClinicalTrials.gov, number NCT01041989.
  
  
  RESULTS
  Between Sept 7, 2009, and Nov 24, 2011, we screened 2654 individuals and randomly assigned 1260 to the intervention group (n=631) or control group (n=629). 591 (94%) participants in the intervention group and 599 (95%) in the control group had at least one post-baseline assessment and were included in the modified intention-to-treat analysis. Estimated mean change in NTB total Z score at 2 years was 0·20 (SE 0·02, SD 0·51) in the intervention group and 0·16 (0·01, 0·51) in the control group. Between-group difference in the change of NTB total score per year was 0·022 (95% CI 0·002-0·042, p=0·030). 153 (12%) individuals dropped out overall. Adverse events occurred in 46 (7%) participants in the intervention group compared with six (1%) participants in the control group; the most common adverse event was musculoskeletal pain (32 [5%] individuals for intervention vs no individuals for control).
  
  
  CONCLUSIONS
  Findings from this large, long-term, randomised controlled trial suggest that a multidomain intervention could improve or maintain cognitive functioning in at-risk elderly people from the general population.
  
  
  BACKGROUND
  Academy of Finland, La Carita Foundation, Alzheimer Association, Alzheimer's Research and Prevention Foundation, Juho Vainio Foundation, Novo Nordisk Foundation, Finnish Social Insurance Institution, Ministry of Education and Culture, Salama bint Hamdan Al Nahyan Foundation, Axa Research Fund, EVO funding for University Hospitals of Kuopio, Oulu, and Turku and for Seinäjoki Central Hospital and Oulu City Hospital, Swedish Research Council, Swedish Research Council for Health, Working Life and Welfare, and af Jochnick Foundation.
authors.affiliation: Chronic Disease Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland; Karolinska Institutet Center for Alzheimer Research, Stockholm, Sweden.
authors.forename: Tiia
authors.initials: T
authors.lastname: Ngandu
authors.affiliation: Chronic Disease Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland.
authors.forename: Jenni
authors.initials: J
authors.lastname: Lehtisalo
authors.affiliation: Karolinska Institutet Center for Alzheimer Research, Stockholm, Sweden; Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland; Aging Research Center, Karolinska Institutet-Stockholm University, Stockholm, Sweden.
authors.forename: Alina
authors.initials: A
authors.lastname: Solomon
authors.affiliation: Chronic Disease Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland.
authors.forename: Esko
authors.initials: E
authors.lastname: Levälahti
authors.affiliation: Chronic Disease Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland.
authors.forename: Satu
authors.initials: S
authors.lastname: Ahtiluoto
authors.affiliation: Institute of Health Sciences/Geriatrics, University of Oulu and Oulu University Hospital, Oulu, Finland; Medical Research Center Oulu, Oulu University Hospital, Oulu, Finland; Oulu City Hospital, Oulu, Finland.
authors.forename: Riitta
authors.initials: R
authors.lastname: Antikainen
authors.affiliation: Aging Research Center, Karolinska Institutet-Stockholm University, Stockholm, Sweden.
authors.forename: Lars
authors.initials: L
authors.lastname: Bäckman
authors.affiliation: Department of Neurology, Kuopio University Hospital, Kuopio, Finland.
authors.forename: Tuomo
authors.initials: T
authors.lastname: Hänninen
authors.affiliation: Chronic Disease Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland.
authors.forename: Antti
authors.initials: A
authors.lastname: Jula
authors.affiliation: Chronic Disease Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland; Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.
authors.forename: Tiina
authors.initials: T
authors.lastname: Laatikainen
authors.affiliation: Chronic Disease Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland.
authors.forename: Jaana
authors.initials: J
authors.lastname: Lindström
authors.affiliation: Aging Research Center, Karolinska Institutet-Stockholm University, Stockholm, Sweden.
authors.forename: Francesca
authors.initials: F
authors.lastname: Mangialasche
authors.affiliation: Finnish Institute of Occupational Health, Helsinki, Finland.
authors.forename: Teemu
authors.initials: T
authors.lastname: Paajanen
authors.affiliation: Welfare and Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.
authors.forename: Satu
authors.initials: S
authors.lastname: Pajala
authors.affiliation: Chronic Disease Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland.
authors.forename: Markku
authors.initials: M
authors.lastname: Peltonen
authors.affiliation: Department of Clinical Physiology and Nuclear Medicine, Kuopio University Hospital, Kuopio, Finland; Kuopio Research Institute of Exercise Medicine, Kuopio, Finland.
authors.forename: Rainer
authors.initials: R
authors.lastname: Rauramaa
authors.affiliation: Department of Psychology, Umeå University, Umeå, Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Stigsdotter-Neely
authors.affiliation: Institute of Health Sciences/Geriatrics, University of Oulu and Oulu University Hospital, Oulu, Finland; Department of Medicine, Geriatric Clinic, University of Helsinki, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Timo
authors.initials: T
authors.lastname: Strandberg
authors.affiliation: Chronic Disease Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland; Department of Public Health, HJELT Institute, University of Helsinki, Helsinki University Central Hospital, Helsinki, Finland; South Ostrobothnia Central Hospital, Seinäjoki, Finland; Center for Vascular Prevention, Danube-University Krems, Krems, Austria; Diabetes Research Group, King Abdulaziz University, Jeddah, Saudi Arabia.
authors.forename: Jaakko
authors.initials: J
authors.lastname: Tuomilehto
authors.affiliation: Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland; Department of Neurology, Kuopio University Hospital, Kuopio, Finland.
authors.forename: Hilkka
authors.initials: H
authors.lastname: Soininen
authors.affiliation: Chronic Disease Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland; Karolinska Institutet Center for Alzheimer Research, Stockholm, Sweden; Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland; Aging Research Center, Karolinska Institutet-Stockholm University, Stockholm, Sweden. Electronic address: miia.kivipelto@ki.se.
authors.forename: Miia
authors.initials: M
authors.lastname: Kivipelto
mesh_terms: D000368:Aged; D003072:Cognition Disorders / Q000453:epidemiology / Q000517:prevention & control*; D004032:Diet; D004311:Double-Blind Method; D015444:Exercise; D005081:Exercise Therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D018570:Risk Assessment; D014652:Vascular Diseases / Q000453:epidemiology* / Q000517:prevention & control