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The effect of adherence on cognition in a multidomain lifestyle intervention (FINGER).
Ngandu, T, Lehtisalo, J, Korkki, S, Solomon, A, Coley, N, Antikainen, R, Bäckman, L, Hänninen, T, Lindström, J, Laatikainen, T, et al
Alzheimer's & dementia : the journal of the Alzheimer's Association. 2022;(7):1325-1334
Abstract
INTRODUCTION Lifestyle interventions may prevent cognitive decline, but the sufficient dose of intervention activities and lifestyle changes is unknown. We investigated how intervention adherence affects cognition in the FINGER trial (pre-specified subgroup analyses). METHODS FINGER is a multicenter randomized controlled trial examining the efficacy of multidomain lifestyle intervention (ClinicalTrials.gov NCT01041989). A total of 1260 participants aged 60 to 77 with increased dementia risk were randomized to a lifestyle intervention and control groups. Percentage of completed intervention sessions, and change in multidomain lifestyle score (self-reported diet; physical, cognitive, and social activity; vascular risk) were examined in relation to change in Neuropsychological Test Battery (NTB) scores. RESULTS Active participation was associated with better trajectories in NTB total and all cognitive subdomains. Improvement in lifestyle was associated with improvement in NTB total and executive function. DISCUSSION Multidomain lifestyle changes are beneficial for cognitive functioning, but future interventions should be intensive enough, and supporting adherence is essential.
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Effect of a Multidomain Lifestyle Intervention on Estimated Dementia Risk.
Solomon, A, Handels, R, Wimo, A, Antikainen, R, Laatikainen, T, Levälahti, E, Peltonen, M, Soininen, H, Strandberg, T, Tuomilehto, J, et al
Journal of Alzheimer's disease : JAD. 2021;82(4):1461-1466
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Early identification of individuals at-risk of dementia is essential for effective preventive strategies. The aim of this study was to investigate the effect of a multidomain lifestyle intervention on the risk of dementia. This study is a post-hoc analyses of intervention effects on change in the Cardiovascular Risk Factors, Aging and Dementia (CAIDE) Dementia Risk Score. The CAIDE score was used to select at-risk participants to the FINGER trial. FINGER is a multicentre study conducted in 6 centres in Finland. Results show a significant beneficial intervention effect, especially in women, on reducing estimated dementia risk measured by the CAIDE score. Authors conclude that CAIDE risk score can be used as a tool to communicate dementia risk, and to select persons that may benefit from lifestyle interventions.
Abstract
We investigated the effect of a multidomain lifestyle intervention on the risk of dementia estimated using the validated CAIDE risk score (post-hoc analysis). The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) is a 2-year randomized controlled trial among 1,260 at-risk older adults (60-77 years). Difference in the estimated mean change in CAIDE score at 2 years in the intervention compared to the control group was -0.16 (95 %CI -0.31 to 0.00) (p = 0.013), corresponding to a relative dementia risk reduction between 6.04-6.50%. This could be interpreted as a reflection of the prevention potential of the intervention.
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Telomere Length Change in a Multidomain Lifestyle Intervention to Prevent Cognitive Decline: A Randomized Clinical Trial.
Sindi, S, Solomon, A, Kåreholt, I, Hovatta, I, Antikainen, R, Hänninen, T, Levälahti, E, Laatikainen, T, Lehtisalo, J, Lindström, J, et al
The journals of gerontology. Series A, Biological sciences and medical sciences. 2021;(3):491-498
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BACKGROUND Shorter leukocyte telomere length (LTL) is associated with aging and dementia. Impact of lifestyle changes on LTL, and relation to cognition and genetic susceptibility for dementia, has not been investigated in randomized controlled trials (RCTs). METHODS Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability is a 2-year RCT enrolling 1260 participants at risk for dementia from the general population, aged 60-77 years, randomly assigned (1:1) to multidomain lifestyle intervention or control group. The primary outcome was cognitive change (Neuropsychological Test Battery z-score). Relative LTL was measured using quantitative real-time polymerase chain reaction (trial registration: NCT01041989). RESULTS This exploratory LTL substudy included 756 participants (377 intervention, 379 control) with baseline and 24-month LTL measurements. The mean annual LTL change (SD) was -0.016 (0.19) in the intervention group and -0.023 (0.17) in the control group. Between-group difference was nonsignificant (unstandardized β-coefficient 0.007, 95% CI -0.015 to 0.030). Interaction analyses indicated better LTL maintenance among apolipoprotein E (APOE)-ε4 carriers versus noncarriers: 0.054 (95% CI 0.007 to 0.102); younger versus older participants: -0.005 (95% CI -0.010 to -0.001); and those with more versus less healthy lifestyle changes: 0.047 (95% CI 0.005 to 0.089). Cognitive intervention benefits were more pronounced among participants with better LTL maintenance for executive functioning (0.227, 95% CI 0.057 to 0.396) and long-term memory (0.257, 95% CI 0.024 to 0.489), with a similar trend for Neuropsychological Test Battery total score (0.127, 95% CI -0.011 to 0.264). CONCLUSIONS This is the first large RCT showing that a multidomain lifestyle intervention facilitated LTL maintenance among subgroups of older people at risk for dementia, including APOE-ε4 carriers. LTL maintenance was associated with more pronounced cognitive intervention benefits. CLINICAL TRIALS REGISTRATION NUMBER NCT01041989.
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Self and Informant Memory Reports in FINGER: Associations with Two-Year Cognitive Change.
Vaskivuo, L, Hokkanen, L, Hänninen, T, Antikainen, R, Bäckman, L, Laatikainen, T, Paajanen, T, Stigsdotter-Neely, A, Strandberg, T, Tuomilehto, J, et al
Journal of Alzheimer's disease : JAD. 2019;(3):785-795
Abstract
BACKGROUND Subjective memory complaints (SMCs) may be the first sign of cognitive decline in aging. OBJECTIVE To examine whether SMCs reported by oneself and informant predict cognitive change over 2 years among at-risk elderly people, and to determine the relationship of different types of SMCs (prospective and retrospective memory complaints) and change in cognitive function. METHODS This investigation is part of the FINGER project, which is a multicenter randomized controlled trial aiming at preventing cognitive decline in cognitively healthy older adults with increased risk of dementia. A subsample of 303 control-group participants (aged 60-80 years) and their informants (n = 261) rated the frequency of SMCs, using the Prospective and Retrospective Memory Questionnaire (PRMQ). Cognitive performance was measured at baseline and at 1- and 2-year follow-up visits using a neuropsychological test battery. RESULTS Participants who reported more SMCs improved less in global cognition, executive function, and memory during the subsequent 2 years in the fully-adjusted analyses. Self-reported retrospective memory problems predicted less improvement in all cognitive domains, whereas prospective memory problems did not. Informant-reported memory problems were not linked to subsequent change in cognition. CONCLUSION Our results indicate that self-reported SMCs, measured with PRMQ, predict future cognitive change in several cognitive domains. By contrast, reports by informants were not linked to changes in cognition. Among cognitively healthy at-risk elderly individuals, the persons themselves observe more easily problems relevant for their future cognitive trajectories than their informants.
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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.
Marengoni, A, Rizzuto, D, Fratiglioni, L, Antikainen, R, Laatikainen, T, Lehtisalo, J, Peltonen, M, Soininen, H, Strandberg, T, Tuomilehto, J, et al
Journal of the American Medical Directors Association. 2018;(4):355-360.e1
Abstract
OBJECTIVE To verify whether a multidomain intervention lowers the risk of developing new chronic diseases in older adults. METHODS Multicenter, double-blind randomized controlled trial started in October 2009, with 2-year follow-up. A total of 1260 people aged 60 to 77 years were enrolled in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER). Participants were randomly assigned in a 1:1 ratio to a 2-year multidomain intervention (n = 631) (nutritional guidance, exercise, cognitive training, and management of metabolic and vascular risk factors) or a control group (n = 629) (general health advice). Data on most common chronic diseases were collected by a physician at baseline and 2 years later. RESULTS At 2-year follow-up, the average number of new chronic diseases was 0.47 [standard deviation (SD) 0.7] in the intervention group and 0.58 (SD 0.8) in the control group (P < .01). The incidence rate per 100 person-years for developing 1+ new disease(s) was 17.4 [95% confidence interval (CI) = 15.1-20.1] in the intervention group and 20.5 (95% CI = 18.0-23.4) in the control group; for developing 2+ new diseases, 4.9 (95% CI = 3.7-6.4) and 6.1 (95% CI = 4.8-7.8); and for 3+ new diseases, 0.7 (95% CI = 0.4-1.5) and 1.8 (95% CI = 1.1-2.8), respectively. After adjustment for age, sex, education, current smoking, alcohol intake, and the number of chronic diseases at baseline, the intervention group had a hazard ratio ranging from 0.80 (0.66-0.98) for developing 1+ new chronic disease(s) to 0.38 (0.16-0.88) for developing 3+ new chronic diseases compared to the control group. CONCLUSIONS Findings from this randomized controlled trial suggest that a multidomain intervention could reduce the risk of developing new chronic diseases in older people.
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Multidomain lifestyle intervention benefits a large elderly population at risk for cognitive decline and dementia regardless of baseline characteristics: The FINGER trial.
Rosenberg, A, Ngandu, T, Rusanen, M, Antikainen, R, Bäckman, L, Havulinna, S, Hänninen, T, Laatikainen, T, Lehtisalo, J, Levälahti, E, et al
Alzheimer's & dementia : the journal of the Alzheimer's Association. 2018;(3):263-270
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INTRODUCTION The 2-year Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) multidomain lifestyle intervention trial (NCT01041989) demonstrated beneficial effects on cognition. We investigated whether sociodemographics, socioeconomic status, baseline cognition, or cardiovascular factors influenced intervention effects on cognition. METHODS The FINGER recruited 1260 people from the general Finnish population (60-77 years, at risk for dementia). Participants were randomized 1:1 to multidomain intervention (diet, exercise, cognition, and vascular risk management) and regular health advice. Primary outcome was change in cognition (Neuropsychological Test Battery z-score). Prespecified analyses to investigate whether participants' characteristics modified response to intervention were carried out using mixed-model repeated-measures analyses. RESULTS Sociodemographics (sex, age, and education), socioeconomic status (income), cognition (Mini-Mental State Examination), cardiovascular factors (body mass index, blood pressure, cholesterol, fasting glucose, and overall cardiovascular risk), and cardiovascular comorbidity did not modify response to intervention (P-values for interaction > .05). CONCLUSIONS The FINGER intervention was beneficial regardless of participants' characteristics and can thus be implemented in a large elderly population at increased risk for dementia.
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Significant disparities in allergy prevalence and microbiota between the young people in Finnish and Russian Karelia.
Ruokolainen, L, Paalanen, L, Karkman, A, Laatikainen, T, von Hertzen, L, Vlasoff, T, Markelova, O, Masyuk, V, Auvinen, P, Paulin, L, et al
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology. 2017;(5):665-674
Abstract
BACKGROUND Atopic allergy has been more common among schoolchildren in Finland, as compared to Russian Karelia. These adjacent regions show one of the most contrasting socio-economical differences in the world. OBJECTIVE We explored changes in allergy from school age to young adulthood from 2003 to 2010/2012 in these two areas. The skin and nasal microbiota were also compared. METHODS Randomly selected children from Finnish (n = 98) and Russian Karelia (n = 82) were examined in 2003, when the children were 7-11 years of age, and again in 2010 (Finnish Karelia) and 2012 (Russian Karelia). We analysed self-reported allergy symptoms and sensitization to common allergens by serum sIgE values. The skin (volar forearm) and nasal mucosa microbiota, collected in 2012 (aged 15-20 years), identified from DNA samples, were compared with multivariate methods. RESULTS Asthma, hay fever, atopic eczema, self-reported rhinitis, as well as atopic sensitization, were threefold to 10-fold more common in Finland, as compared to Russian Karelia. Hay fever and peanut sensitization were almost non-existent in Russia. These patterns remained throughout the 10-year follow-up. Skin microbiota, as well as bacterial and fungal communities in nasal mucosa, was contrastingly different between the populations, best characterized by the diversity and abundance of genus Acinetobacter; more abundant and diverse in Russia. Overall, diversity was significantly higher among Russian subjects (Pskin < 0.0001, Pnasal-bacteria < 0.0001 and Pnasal-fungi < 0.01). Allergic diseases were not associated with microbial diversity in Finnish subjects. CONCLUSIONS AND CLINICAL RELEVANCE Differences in allergic phenotype, developed in early life, remain between populations. A parallel difference in the composition of skin and nasal microbiota suggests a potential underlying mechanism. Our results also suggest that high abundance and diversity of Acinetobacter might contribute to the low allergy prevalence in Russia. Implications of early-life exposure to Acinetobacter should be further investigated.
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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.
Ngandu, T, Lehtisalo, J, Solomon, A, Levälahti, E, Ahtiluoto, S, Antikainen, R, Bäckman, L, Hänninen, T, Jula, A, Laatikainen, T, et al
Lancet (London, England). 2015;(9984):2255-63
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. FINDINGS 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). INTERPRETATION 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. FUNDING 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.
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The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress.
Kivipelto, M, Solomon, A, Ahtiluoto, S, Ngandu, T, Lehtisalo, J, Antikainen, R, Bäckman, L, Hänninen, T, Jula, A, Laatikainen, T, et al
Alzheimer's & dementia : the journal of the Alzheimer's Association. 2013;(6):657-65
Abstract
BACKGROUND Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) is a multi-center, randomized, controlled trial ongoing in Finland. MATERIALS Participants (1200 individuals at risk of cognitive decline) are recruited from previous population-based non-intervention studies. Inclusion criteria are CAIDE Dementia Risk Score ≥6 and cognitive performance at the mean level or slightly lower than expected for age (but not substantial impairment) assessed with the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) neuropsychological battery. The 2-year multidomain intervention consists of: nutritional guidance; exercise; cognitive training and social activity; and management of metabolic and vascular risk factors. Persons in the control group receive regular health advice. The primary outcome is cognitive performance as measured by the modified Neuropsychological Test Battery, Stroop test, and Trail Making Test. Main secondary outcomes are: dementia (after extended follow-up); disability; depressive symptoms; vascular risk factors and outcomes; quality of life; utilization of health resources; and neuroimaging measures. RESULTS Screening began in September 2009 and was completed in December 2011. All 1200 persons are enrolled and the intervention is ongoing as planned. Baseline clinical characteristics indicate that several vascular risk factors and unhealthy lifestyle-related factors are present, creating a window of opportunity for prevention. The intervention will be completed during 2014. CONCLUSIONS The FINGER is at the forefront of international collaborative efforts to solve the clinical and public health problems of early identification of individuals at increased risk of late-life cognitive impairment, and of developing intervention strategies to prevent or delay the onset of cognitive impairment and dementia.
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Intrauterine 10 microg and 20 microg levonorgestrel systems in postmenopausal women receiving oral oestrogen replacement therapy: clinical, endometrial and metabolic response.
Raudaskoski, T, Tapanainen, J, Tomás, E, Luotola, H, Pekonen, F, Ronni-Sivula, H, Timonen, H, Riphagen, F, Laatikainen, T
BJOG : an international journal of obstetrics and gynaecology. 2002;(2):136-44
Abstract
OBJECTIVE The clinical and endometrial efficacy and lipid response of two different doses of intrauterine levonorgestrel were assessed in comparison with sequential oral medroxyprogesterone acetate in postmenopausal women receiving continuous oral E2-valerate. DESIGN One-year prospective multicentre randomised control trial. SETTING Four outpatient clinics in Oulu, Helsinki and Jyväskylä, Finland. POPULATION A total of 163 healthy volunteer postmenopausal women with climacteric complaints or already using hormone replacement therapy (HRT). INTERVENTIONS Subjects were randomly allocated to receive a new intrauterine system releasing 10 microg of levonorgestrel daily or an established intrauterine system (Mirena) releasing 20 microg of levonorgestrel daily or sequential oral medroxyprogesterone acetate (5mg/day, 14/30 days). All three regimens were combined with an oral daily dose of 2mg of E2-valerate. MAIN OUTCOME MEASURES Bleeding patterns were assessed by diaries kept by the subjects. Endometrial effects were evaluated by histologic biopsies taken at the baseline and after six and 12 months of therapy. Serum concentrations of total, HDL and LDL cholesterol, triglycerides and lipoprotein(a) were determined at the baseline and after six and 12 months of therapy. RESULTS Insertion of the smaller 10 microg levonorgestrel system was easy in 70% and difficult in 4% and that of Mirena was easy in 46% and difficult in 21% of the subjects. After six months of therapy, 43 (95.6%) of the 47 subjects receiving 10 microg levonorgestrel and 54 (98.2%) of the 55 subjects receiving 20 microg levonorgestrel had no bleeding, while the sequential medroxyprogesterone acetate regimen produced typical cyclic withdrawal bleedings. Endometrial hyperplasia was not observed in any of the treatment groups during the 12-month study. After 12 months of therapy, strong endometrial suppression was found in 46/47 and 55/55 of the subjects receiving 10 microg and 20 microg of levonorgestrel, respectively, while the endometrium was proliferative in 18/47 of the subjects in the medroxyprogesterone acetate group. Serum total cholesterol decreased in all treatment groups. HDL cholesterol increased in women receiving medroxyprogesterone acetate or the smaller intrauterine dose of levonorgestrel. CONCLUSIONS Both intrauterine doses of levonorgestrel provided good endometrial protection in postmenopausal women on oestrogen replacement therapy. The advantage of the 10 microg system with a smaller size is the easier insertion of the system and a minimal attenuation of the favourable effects of oral oestrogen on the serum lipid profile.