Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
NCT ID: NCT01041989
Last Updated: 2023-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
1200 participants
INTERVENTIONAL
2009-09-30
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sociodemographic Factors and Criminal Behaviour Preceding Neurodegenerative Disease - Retrospective Register Study
NCT06209515
Cognitively Enriched Walking Program
NCT05500183
Multiple Interventions to Prevent Cognitive Decline
NCT04079075
Behavioral Interventions to Prevent or Delay Dementia
NCT02265757
Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention
NCT04616794
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard health counseling at baseline
No interventions assigned to this group
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.
Nutritional guidance
Individual counseling sessions and group meetings will be organized.
Exercise
Guided muscle strength training and aerobic exercise.
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.
Reduction of vascular risk factors
Monitoring and maintenance of metabolic and vascular risk factors
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nutritional guidance
Individual counseling sessions and group meetings will be organized.
Exercise
Guided muscle strength training and aerobic exercise.
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.
Reduction of vascular risk factors
Monitoring and maintenance of metabolic and vascular risk factors
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
60 Years
77 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Academy of Finland
OTHER
University of Helsinki
OTHER
University of Eastern Finland
OTHER
University of Oulu
OTHER
Kuopio Research Institute of Exercise Medicine
OTHER
Western University, Canada
OTHER
Karolinska Institutet
OTHER
Umeå University
OTHER
Finnish Institute for Health and Welfare
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Miia Kivipelto
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Miia Kivipelto, professor
Role: PRINCIPAL_INVESTIGATOR
Finnish Institute for Health and Welfare
Tiina K Laatikainen, professor
Role: STUDY_DIRECTOR
Finnish Institute for Health and Welfare
Hilkka S Soininen, professor
Role: STUDY_DIRECTOR
University of Eastern Finland
Jaakko Tuomilehto, professor
Role: STUDY_DIRECTOR
University of Helsinki
Timo E Strandberg, professor
Role: STUDY_DIRECTOR
University of Oulu
Raimo Sulkava, professor
Role: STUDY_DIRECTOR
University of Eastern Finland
Rainer Rauramaa, professor
Role: STUDY_DIRECTOR
Kuopio Research Institute of Exercise Medicine
Antti Jula, research prof
Role: STUDY_DIRECTOR
Finnish Institute for Health and Welfare
Markku Peltonen, research professor
Role: STUDY_DIRECTOR
Finnish Institute for Health and Welfare
Satu Havulinna, PhD
Role: STUDY_DIRECTOR
Finnish Institute for Health and Welfare
Jaana Lindström, Adjunct prof.
Role: STUDY_DIRECTOR
Finnish Institute for Health and Welfare
Riitta Antikainen, professor
Role: STUDY_DIRECTOR
Oulu City Health Services
Tiia Ngandu, MD, PhD, Adjunct professor
Role: STUDY_DIRECTOR
Finnish Institute for Health and Welfare
Tuomo Hänninen, Adjunct prof
Role: STUDY_DIRECTOR
University of Eastern Finland
Jenni Lehtisalo, PhD
Role: STUDY_DIRECTOR
Finnish Institute for Health and Welfare
Alina Solomon, MD, PhD, Adjunct professor
Role: STUDY_DIRECTOR
University of Eastern Finland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Finnish Institute for Health and Welfare
Helsinki, , Finland
University of Eastern Finland
Kuopio, , Finland
University of Oulu
Oulu, , Finland
Research Center Mediwest
Seinäjoki, , Finland
Finnish Institute for Health and Welfare
Turku, , Finland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1016/S1474-4422(06)70537-3.
Kivipelto M, Helkala EL, Laakso MP, Hanninen 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. doi: 10.1136/bmj.322.7300.1447.
Kivipelto M, Helkala EL, Hanninen 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. doi: 10.1212/wnl.56.12.1683.
Kivipelto M, Helkala EL, Laakso MP, Hanninen 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. doi: 10.7326/0003-4819-137-3-200208060-00006.
Rovio S, Kareholt 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. doi: 10.1016/S1474-4422(05)70198-8.
Kivipelto M, Ngandu T, Fratiglioni L, Viitanen M, Kareholt 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. doi: 10.1001/archneur.62.10.1556.
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. doi: 10.1016/S0140-6736(06)69701-8.
Kivipelto M, Rovio S, Ngandu T, Kareholt 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. doi: 10.1111/j.1582-4934.2008.00296.x. Epub 2008 Feb 8.
Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17.
Ngandu T, Lehtisalo J, Levalahti E, Laatikainen T, Lindstrom J, Peltonen M, Solomon A, Ahtiluoto S, Antikainen R, Hanninen T, Jula A, Mangialasche F, Paajanen T, Pajala S, Rauramaa R, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. Recruitment and baseline characteristics of participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)-a randomized controlled lifestyle trial. Int J Environ Res Public Health. 2014 Sep 10;11(9):9345-60. doi: 10.3390/ijerph110909345.
Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. 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. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
Kulmala J, Ngandu T, Pajala S, Lehtisalo J, Levalahti E, Antikainen R, Laatikainen T, Oksa H, Peltonen M, Rauramaa R, Soininen H, Strandberg T, Tuomilehto J, Kivipelto M. Leisure-Time and Occupational Physical Activity in Early and Late Adulthood in Relation to Later Life Physical Functioning. J Phys Act Health. 2016 Oct;13(10):1079-1087. doi: 10.1123/jpah.2015-0664. Epub 2016 Aug 16.
Strandberg TE, Levälahti E, Ngandu T, Solomon A, M Kivipelto for FINGER Study Group. Health-Related Quality of Life in a Multidomain Intervention Trial to Prevent Cognitive Decline (FINGER). Eur Ger Med. 2017; 8: 164-167.
Lehtisalo J, Ngandu T, Valve P, Antikainen R, Laatikainen T, Strandberg T, Soininen H, Tuomilehto J, Kivipelto M, Lindstrom J. Nutrient intake and dietary changes during a 2-year multi-domain lifestyle intervention among older adults: secondary analysis of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) randomised controlled trial. Br J Nutr. 2017 Aug;118(4):291-302. doi: 10.1017/S0007114517001982.
Marengoni A, Rizzuto D, Fratiglioni L, Antikainen R, Laatikainen T, Lehtisalo J, Peltonen M, Soininen H, Strandberg T, Tuomilehto J, Kivipelto M, Ngandu T. The Effect of a 2-Year Intervention Consisting of Diet, Physical Exercise, Cognitive Training, and Monitoring of Vascular Risk on Chronic Morbidity-the FINGER Randomized Controlled Trial. J Am Med Dir Assoc. 2018 Apr;19(4):355-360.e1. doi: 10.1016/j.jamda.2017.09.020. Epub 2017 Nov 3.
Solomon A, Handels R, Wimo A, Antikainen R, Laatikainen T, Levalahti E, Peltonen M, Soininen H, Strandberg T, Tuomilehto J, Kivipelto M, Ngandu T. Effect of a Multidomain Lifestyle Intervention on Estimated Dementia Risk. J Alzheimers Dis. 2021;82(4):1461-1466. doi: 10.3233/JAD-210331.
Lehtisalo J, Rusanen M, Solomon A, Antikainen R, Laatikainen T, Peltonen M, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M, Ngandu T. Effect of a multi-domain lifestyle intervention on cardiovascular risk in older people: the FINGER trial. Eur Heart J. 2022 Jun 1;43(21):2054-2061. doi: 10.1093/eurheartj/ehab922.
Wimo A, Handels R, Antikainen R, Eriksdotter M, Jonsson L, Knapp M, Kulmala J, Laatikainen T, Lehtisalo J, Peltonen M, Skoldunger A, Soininen H, Solomon A, Strandberg T, Tuomilehto J, Ngandu T, Kivipelto M. Dementia prevention: The potential long-term cost-effectiveness of the FINGER prevention program. Alzheimers Dement. 2023 Mar;19(3):999-1008. doi: 10.1002/alz.12698. Epub 2022 Jul 16.
Lorenzon G, Marseglia A, Mohanty R, Lehtisalo J, Poulakis K, Ngandu T, Solomon A, Kivipelto M, Westman E. Brain patterns and risk factors in the FINGER RCT multimodal lifestyle intervention. J Prev Alzheimers Dis. 2025 Sep 24:100390. doi: 10.1016/j.tjpad.2025.100390. Online ahead of print.
Lorenzo T, Ngandu T, Lehtisalo J, Antikainen R, Gispert JD, Kemppainen N, Laatikainen T, Lindstrom J, Rinne J, Soininen H, Strandberg T, Torre R, Tuomilehto J, Solomon A, Kivipelto M. Associations of Prediabetes, Diabetes and Glucose-Related Markers With Cognition and Neuroimaging in a 2-Year Multidomain Lifestyle Randomised Controlled Trial. Diabetes Metab Res Rev. 2025 Jul;41(5):e70053. doi: 10.1002/dmrr.70053.
Lehtisalo J, Saaskilahti M, Harkanen T, Kulmala J, Hemio K, Siltanen S, Zhi Z, Mangialasche F, Laatikainen T, Strandberg T, Antikainen R, Tuomilehto J, Soininen H, Kivipelto M, Ngandu T. Changes in older persons' lifestyle and perceived health over time and during the COVID-19 pandemic: findings from the extended follow-up of the FINGER randomized controlled trial from 2009 to 2020. BMC Geriatr. 2025 May 3;25(1):308. doi: 10.1186/s12877-025-05979-6.
Kekkonen E, Hall A, Antikainen R, Havulinna S, Kivipelto M, Kulmala J, Laatikainen T, Paajanen TI, Sindi S, Soininen H, Strandberg T, Tuomilehto J, Ngandu T, Solomon A. Impaired sleep, depressive symptoms, and pain as determinants of physical activity and exercise intervention adherence: an exploratory analysis of a randomized clinical trial. BMC Geriatr. 2025 Mar 29;25(1):211. doi: 10.1186/s12877-025-05830-y.
Vaskivuo L, Hokkanen L, Levalahti E, Hanninen T, Antikainen R, Backman L, Laatikainen T, Paajanen T, Stigsdotter Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M, Ngandu T. Subjective Memory Complaints and the Effect of a Multidomain Lifestyle Intervention on Cognition: The FINGER Trial. J Gerontol B Psychol Sci Soc Sci. 2024 Dec 11;80(1):gbae179. doi: 10.1093/geronb/gbae179.
Goikolea J, Gerenu G, Daniilidou M, Mangialasche F, Mecocci P, Ngandu T, Rinne J, Solomon A, Kivipelto M, Cedazo-Minguez A, Sandebring-Matton A, Maioli S. Serum Thioredoxin-80 is associated with age, ApoE4, and neuropathological biomarkers in Alzheimer's disease: a potential early sign of AD. Alzheimers Res Ther. 2022 Feb 24;14(1):37. doi: 10.1186/s13195-022-00979-9.
Alenius M, Ngandu T, Koskinen S, Hallikainen I, Hanninen T, Karrasch M, Kivipelto M, Raivio MM, Laakkonen ML, Kruger J, Suhonen NM, Hokkanen L. Education-Based Cutoffs for Cognitive Screening of Alzheimer's Disease. Dement Geriatr Cogn Disord. 2022;51(1):42-55. doi: 10.1159/000521982. Epub 2022 Feb 23.
Neuvonen E, Lehtisalo J, Solomon A, Antikainen R, Havulinna S, Hanninen T, Laatikainen T, Lindstrom J, Rautio N, Soininen H, Strandberg T, Tuomilehto J, Kivipelto M, Ngandu T. Psychosocial determinants for adherence to a healthy lifestyle and intervention participation in the FINGER trial: an exploratory analysis of a randomised clinical trial. Aging Clin Exp Res. 2022 Aug;34(8):1793-1805. doi: 10.1007/s40520-022-02088-x. Epub 2022 Feb 19.
Ngandu T, Lehtisalo J, Korkki S, Solomon A, Coley N, Antikainen R, Backman L, Hanninen T, Lindstrom J, Laatikainen T, Paajanen T, Havulinna S, Peltonen M, Neely AS, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. The effect of adherence on cognition in a multidomain lifestyle intervention (FINGER). Alzheimers Dement. 2022 Jul;18(7):1325-1334. doi: 10.1002/alz.12492. Epub 2021 Oct 20.
Sandebring-Matton A, Goikolea J, Bjorkhem I, Paternain L, Kemppainen N, Laatikainen T, Ngandu T, Rinne J, Soininen H, Cedazo-Minguez A, Solomon A, Kivipelto M. 27-Hydroxycholesterol, cognition, and brain imaging markers in the FINGER randomized controlled trial. Alzheimers Res Ther. 2021 Mar 6;13(1):56. doi: 10.1186/s13195-021-00790-y.
Sindi S, Solomon A, Kareholt I, Hovatta I, Antikainen R, Hanninen T, Levalahti E, Laatikainen T, Lehtisalo J, Lindstrom J, Paajanen T, Peltonen M, Singh Khalsa D, Wolozin B, Strandberg T, Tuomilehto J, Soininen H, Ngandu T, Kivipelto M; FINGER Study Group. Telomere Length Change in a Multidomain Lifestyle Intervention to Prevent Cognitive Decline: A Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2021 Feb 25;76(3):491-498. doi: 10.1093/gerona/glaa279.
Stephen R, Liu Y, Ngandu T, Antikainen R, Hulkkonen J, Koikkalainen J, Kemppainen N, Lotjonen J, Levalahti E, Parkkola R, Pippola P, Rinne J, Strandberg T, Tuomilehto J, Vanninen R, Kivipelto M, Soininen H, Solomon A; FINGER study group. Brain volumes and cortical thickness on MRI in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER). Alzheimers Res Ther. 2019 Jun 4;11(1):53. doi: 10.1186/s13195-019-0506-z.
Kulmala J, Ngandu T, Havulinna S, Levalahti E, Lehtisalo J, Solomon A, Antikainen R, Laatikainen T, Pippola P, Peltonen M, Rauramaa R, Soininen H, Strandberg T, Tuomilehto J, Kivipelto M. The Effect of Multidomain Lifestyle Intervention on Daily Functioning in Older People. J Am Geriatr Soc. 2019 Jun;67(6):1138-1144. doi: 10.1111/jgs.15837. Epub 2019 Feb 26.
Lehtisalo J, Levalahti E, Lindstrom J, Hanninen T, Paajanen T, Peltonen M, Antikainen R, Laatikainen T, Strandberg T, Soininen H, Tuomilehto J, Kivipelto M, Ngandu T. Dietary changes and cognition over 2 years within a multidomain intervention trial-The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER). Alzheimers Dement. 2019 Mar;15(3):410-417. doi: 10.1016/j.jalz.2018.10.001. Epub 2018 Dec 4.
Solomon A, Turunen H, Ngandu T, Peltonen M, Levalahti E, Helisalmi S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lehtisalo J, Lindstrom J, Paajanen T, Pajala S, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. Effect of the Apolipoprotein E Genotype on Cognitive Change During a Multidomain Lifestyle Intervention: A Subgroup Analysis of a Randomized Clinical Trial. JAMA Neurol. 2018 Apr 1;75(4):462-470. doi: 10.1001/jamaneurol.2017.4365.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
THL/TUET 122/2009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.