Cognitive ImpairmentFINGERNCT01041989
Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
A study testing Nutritional guidance, Exercise and Cognitive training in people with Cognitive Impairment and Dementia, run by University of Eastern Finland at 5 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 77 years
- Conditions the study is for
- Cognitive Impairment, Dementia
- What is being tested?
- Nutritional guidance, Exercise and Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,260 participants
- Where
- 5 sitesFinland
- Study dates
- Sep 2009to 17 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- malignant diseases
- dementia
- substantial cognitive decline
- major depression
- symptomatic cardiovascular disease
- revascularisation within 1 year
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites
Finnish Institute for Health and Welfare
Helsinki, 00300
University of Eastern Finland
Kuopio, 70211
University of Oulu
Oulu, 90014
Study site
Seinäjoki
Finnish Institute for Health and Welfare
Turku, 20720
About this study
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 extended follow-up (until at least 300 participants have developed dementia).
- Conditions
- Cognitive Impairment, Dementia
- Being tested
- Nutritional guidance, Exercise, Cognitive training, Reduction of vascular risk factors
- Keywords
- dementia, cognitive impairment, disability, intervention, elderly, lifestyle counseling
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional guidanceBehavioural
Individual counseling sessions and group meetings will be organized.
ExerciseBehavioural
Guided muscle strength training and aerobic exercise.
Cognitive trainingBehavioural
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 factorsOther
Monitoring and maintenance of metabolic and vascular risk factors
| Study group | Role | What they receive |
|---|---|---|
| Standard health counseling at baseline | No intervention | Not described |
| Lifestyle counseling | Experimental | Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors. Receives: Behavioral: Nutritional guidance; Behavioral: Exercise; Behavioral: Cognitive training; Other: Reduction of vascular risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests.
Measured: 2 years
Secondary outcomes (7)
Depressive symptoms will be assessed using the Zung depression scale.
Measured: 2 years
Disability will be assessed using the ADCS-ADL scale
Measured: 2 years
Quality of Life will be assessed using the RAND-36 and 15D questionnaires.
Measured: 2 years
Utilization of health resources will be assessed using questionnaire and register data.
Measured: 2 years
Vascular and metabolic risk factors will be assessed with blood pressure and anthropometric measurements, and laboratory analyses of metabolic biomarkers.
Measured: 2 years
Vascular and metabolic morbidity and mortality will be assessed through questionnaire and register data.
Measured: 2 years
Changes in dietary biomarker levels will be assessed through laboratory testing.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2013
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Finland, University of Helsinki, University of Oulu, Kuopio Research Institute of Exercise Medicine, Karolinska Institutet, Umeå University, Finnish Institute for Health and Welfare
- Responsible party
- Principal investigator, Tiia Ngandu, University of Eastern Finland
- Investigators
- Miia Kivipelto, Professor, Principal investigator, University of Eastern FinlandTiina Laatikainen, Professor, Study director, University of Eastern FinlandHilkka Soininen, Professor, Study director, University of Eastern FinlandJaakko Tuomilehto, Professor, Study director, University of HelsinkiTimo Strandberg, Professor, Study director, University of OuluMarkku Peltonen, Research professor, Study director, Finnish Institute for Health and WelfareJaana Lindström, Professor, Study director, Finnish Institute for Health and WelfareRiitta Antikainen, Professor, Study director, Oulu City Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041989
- Sponsor's protocol ID
- THL/TUET 122/2009
- Acronym
- FINGER
- Status last verified
- Oct 2026
- First submitted
- 4 Jan 2010
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16914401Kivipelto 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.
PubMed 11408299Kivipelto 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.
PubMed 11425934Kivipelto 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.
PubMed 12160362Rovio 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.
PubMed 16239176Kivipelto 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.
PubMed 16216938Lindstrom 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.
PubMed 17098085Kivipelto 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.
PubMed 18318693Kivipelto 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.
PubMed 23332672Ngandu 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.
PubMed 25211775Ngandu 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.
PubMed 25771249Kulmala 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.
PubMed 27254853Strandberg 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.
PubMed 28875868Marengoni 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.
PubMed 29108888
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
- ClinicalTrials.gov ID
- NCT01041989
- Acronym / sponsor ID
- FINGER / THL/TUET 122/2009
- Conditions
- Cognitive Impairment, Dementia
- Keywords
- dementia, cognitive impairment, disability, intervention, elderly, lifestyle counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,260 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Academy of Finland, University of Helsinki, University of Oulu, Kuopio Research Institute of Exercise Medicine, Karolinska Institutet, Umeå University, Finnish Institute for Health and Welfare
- Study start
- Sep 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 5 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 extended follow-up (until at least 300 participants have developed dementia).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard health counseling at baseline | No intervention | – |
| Lifestyle counseling | Experimental | Behavioral: Nutritional guidance, Behavioral: Exercise, Behavioral: Cognitive training, Other: Reduction of vascular risk factorsMulti-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors. |
Who may qualify
- Ages
- 60 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- malignant diseases
- dementia
- substantial cognitive decline
- major depression
- symptomatic cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional guidanceIndividual counseling sessions and group meetings will be organized. | Behavioural | Lifestyle counseling |
| ExerciseGuided muscle strength training and aerobic exercise. | Behavioural | Lifestyle counseling |
| Cognitive trainingCognitive 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. | Behavioural | Lifestyle counseling |
| Reduction of vascular risk factorsMonitoring and maintenance of metabolic and vascular risk factors | Other | Lifestyle counseling |
Primary outcome
Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests.
Time frame: 2 years
7 secondary outcomes
Depressive symptoms will be assessed using the Zung depression scale.
Time frame: 2 years
Disability will be assessed using the ADCS-ADL scale
Time frame: 2 years
Quality of Life will be assessed using the RAND-36 and 15D questionnaires.
Time frame: 2 years
Utilization of health resources will be assessed using questionnaire and register data.
Time frame: 2 years
Vascular and metabolic risk factors will be assessed with blood pressure and anthropometric measurements, and laboratory analyses of metabolic biomarkers.
Time frame: 2 years
Vascular and metabolic morbidity and mortality will be assessed through questionnaire and register data.
Time frame: 2 years
Changes in dietary biomarker levels will be assessed through laboratory testing.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 16914401Kivipelto 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.
- Background: PubMed 11408299Kivipelto 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.
- Background: PubMed 11425934Kivipelto 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.
- Background: PubMed 12160362Kivipelto 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.
- Background: PubMed 16239176Rovio 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.
- Background: PubMed 16216938Kivipelto 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.
- Background: PubMed 17098085Lindstrom 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.
- Background: PubMed 18318693Kivipelto 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.
- Results publication: PubMed 23332672Kivipelto 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.
- Results publication: PubMed 25211775Ngandu 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.
- Results publication: PubMed 25771249Ngandu 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.
- Results publication: PubMed 27254853Kulmala 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.
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miia Kivipelto, Professor principal investigator
University of Eastern Finland
Tiina Laatikainen, Professor study director
University of Eastern Finland
Hilkka Soininen, Professor study director
University of Eastern Finland
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional guidance, Exercise and Cognitive training in people with Cognitive Impairment and Dementia, run by University of Eastern Finland at 5 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01041989, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.