Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)

• Depressive symptoms will be assessed using the Zung depression scale. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• Disability will be assessed using the ADCS-ADL scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• Quality of Life will be assessed using the RAND-36 and 15D questionnaires. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• Utilization of health resources will be assessed using questionnaire and register data. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• Vascular and metabolic risk factors will be assessed with blood pressure and anthropometric measurements, and laboratory analyses of metabolic biomarkers. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• Vascular and metabolic morbidity and mortality will be assessed through questionnaire and register data. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• Changes in dietary biomarker levels will be assessed through laboratory testing. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons at an increased dementia risk. The 2-year multi-domain life-style intervention includes nutritional guidance, exercise, cognitive training, increased social activity, and intensive monitoring and management of metabolic and vascular risk factors. The primary outcome is cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and Stroop and Trail Making tests to capture early cognitive impairment typical for both Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention will reduce cognitive impairment in the study group compared to the control group during the initial 2-year intervention period and reduce dementia incidence after the 7-year extended follow-up.

• Cognitive Impairment
• Dementia

• Behavioral: Nutritional guidance
  Individual counseling sessions and group meetings will be organized.
• Behavioral: Exercise
  Guided muscle strength training and aerobic exercise.
• Behavioral: Cognitive training
  Cognitive training will be implemented through 8 group sessions lead by a psychologist and a computer-based cognitive training program available to participants via the internet.
• Other: Reduction of vascular risk factors
  Monitoring and maintenance of metabolic and vascular risk factors

• No Intervention: Standard health counseling at baseline
• Experimental: Lifestyle counseling
  Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors.
  Interventions:

  • Behavioral: Nutritional guidance
  • Behavioral: Exercise
  • Behavioral: Cognitive training
  • Other: Reduction of vascular risk factors

• Kivipelto M, Ngandu T, Laatikainen T, Winblad B, Soininen H, Tuomilehto J. Risk score for the prediction of dementia risk in 20 years among middle aged people: a longitudinal, population-based study. Lancet Neurol. 2006 Sep;5(9):735-41.
• Kivipelto M, Helkala EL, Laakso MP, Hänninen T, Hallikainen M, Alhainen K, Soininen H, Tuomilehto J, Nissinen A. Midlife vascular risk factors and Alzheimer's disease in later life: longitudinal, population based study. BMJ. 2001 Jun 16;322(7300):1447-51.
• Kivipelto M, Helkala EL, Hänninen T, Laakso MP, Hallikainen M, Alhainen K, Soininen H, Tuomilehto J, Nissinen A. Midlife vascular risk factors and late-life mild cognitive impairment: A population-based study. Neurology. 2001 Jun 26;56(12):1683-9.
• Kivipelto M, Helkala EL, Laakso MP, Hänninen T, Hallikainen M, Alhainen K, Iivonen S, Mannermaa A, Tuomilehto J, Nissinen A, Soininen H. Apolipoprotein E epsilon4 allele, elevated midlife total cholesterol level, and high midlife systolic blood pressure are independent risk factors for late-life Alzheimer disease. Ann Intern Med. 2002 Aug 6;137(3):149-55. Summary for patients in: Ann Intern Med. 2002 Aug 6;137(3):I-18.
• Rovio S, Kåreholt I, Helkala EL, Viitanen M, Winblad B, Tuomilehto J, Soininen H, Nissinen A, Kivipelto M. Leisure-time physical activity at midlife and the risk of dementia and Alzheimer's disease. Lancet Neurol. 2005 Nov;4(11):705-11.
• Kivipelto M, Ngandu T, Fratiglioni L, Viitanen M, Kåreholt I, Winblad B, Helkala EL, Tuomilehto J, Soininen H, Nissinen A. Obesity and vascular risk factors at midlife and the risk of dementia and Alzheimer disease. Arch Neurol. 2005 Oct;62(10):1556-60.
• Lindstrom J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemio K, Hamalainen H, Harkonen P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Mannelin M, Paturi M, Sundvall J, Valle TT, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet. 2006 Nov 11;368(9548):1673-9.
• Kivipelto M, Rovio S, Ngandu T, Kåreholt I, Eskelinen M, Winblad B, Hachinski V, Cedazo-Minguez A, Soininen H, Tuomilehto J, Nissinen A. Apolipoprotein E epsilon4 magnifies lifestyle risks for dementia: a population-based study. J Cell Mol Med. 2008 Dec;12(6B):2762-71. Epub 2008 Feb 8.

Inclusion Criteria:

• aged 60-77 years
• dementia Risk Score 6 points or more
• fulfillment of at least one of the following CERAD criteria: i) MMSE: 20-26 points ii) word list memory task (3x10 words): 19 words or less iii) delayed recall: 75% or less

Exclusion Criteria:

• malignant diseases
• dementia
• substantial cognitive decline
• major depression
• symptomatic cardiovascular disease
• revascularisation within 1 year
• severe loss of vision, hearing or communicative ability
• other conditions inhibiting from safe engagement in the prescribed intervention as judged by the study physician
• other conditions preventing from cooperation as judged by the study physician

• Academy of Finland
• Helsinki University
• University of Eastern Finland
• University of Oulu
• Kuopio Research Institute of Exercise Medicine
• University of Western Ontario, Canada
• Karolinska Institutet
• Umeå University