Quantifying dementia prevention potential in the FINGER randomized controlled trial using the LIBRA prevention index.
Ontology highlight
ABSTRACT: Introduction
Individuals in early dementia prevention trials may differ in how much they benefit from interventions depending on their initial risk level. Additionally, modifiable dementia risk scores might be used as surrogate/intermediate outcomes.Methods
In the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), we investigated in post hoc analyses (N = 1207) whether the cognitive benefits of the 2-year multi-domain lifestyle intervention differed by baseline dementia risk measured with the "LIfestyle for BRAin Health" (LIBRA) score. We also investigated intervention effects on change in LIBRA score over time.Results
Overall, higher baseline LIBRA was related to less cognitive improvement over time. This association did not differ between the intervention and control groups. The intervention was effective in decreasing LIBRA scores over time, regardless of baseline demographics or cognition.Discussion
The cognitive benefit of the FINGER intervention was similar across individuals with different LIBRA scores at baseline. Furthermore, LIBRA may be useful as a surrogate/intermediate endpoint and surveillance tool to monitor intervention success during trial execution.
SUBMITTER: Deckers K
PROVIDER: S-EPMC8359273 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundSelecting high-risk participants for dementia prevention trials based on a modifiable dementia risk score may be advantageous, as it increases the opportunity for intervention. We studied whether a multi-domain intervention can prevent all-cause dementia and cognitive decline in older people across three different levels of a modifiable dementia risk score.MethodsPrevention of Dementia by Intensive Vascular Care (preDIVA) is a randomised controlled trial studying the effect of multi-domain vascular care during 6-8 years on incident all-cause dementia in community-dwelling people aged 70-78 years. For this post hoc analysis, we stratified preDIVA participants in tertiles based on their baseline LIfestyle for BRAin Health (LIBRA) index, a modifiable dementia risk score. With Cox proportional hazards regression, the intervention effect on dementia was assessed. The effect on cognition was measured every 2 years with the Mini-Mental State Examination and Visual Association Test.ResultsDementia developed in 220 of 3274 (6.7%) participants. In participants with a low, intermediate and high LIBRA index, the hazard ratio (HR) of the intervention on incident dementia was respectively 0.71 (95% CI 0.45-1.12), 1.06 (95% CI 0.66-1.69) and 1.02 (95% CI 0.64-1.62). Also, when adding the non-modifiable risk factors age, education and sex to the index, results were comparable (respectively HR 0.88, 95% CI 0.54-1.43; HR 0.91, 95% CI 0.57-1.47; HR 0.92, 95% CI 0.59-1.41). There was no statistically significant intervention effect on cognition during follow-up across the LIBRA groups.ConclusionsIn the preDIVA study population aged 70-78 years, the LIBRA modifiable dementia risk score did not identify a (high-)risk group in whom the multi-domain intervention was effective in preventing dementia or cognitive decline.Trial registrationInternational Standard Randomised Controlled Trial Number registry, ISRCTN29711771 . Registered on 14 February 2006.
| S-EPMC6026510 | biostudies-literature
Project description:ContextGinkgo biloba is widely used for its potential effects on memory and cognition. To date, adequately powered clinical trials testing the effect of G. biloba on dementia incidence are lacking.ObjectiveTo determine effectiveness of G. biloba vs placebo in reducing the incidence of all-cause dementia and Alzheimer disease (AD) in elderly individuals with normal cognition and those with mild cognitive impairment (MCI).Design, setting, and participantsRandomized, double-blind, placebo-controlled clinical trial conducted in 5 academic medical centers in the United States between 2000 and 2008 with a median follow-up of 6.1 years. Three thousand sixty-nine community volunteers aged 75 years or older with normal cognition (n = 2587) or MCI (n = 482) at study entry were assessed every 6 months for incident dementia.InterventionTwice-daily dose of 120-mg extract of G. biloba (n = 1545) or placebo (n = 1524).Main outcome measuresIncident dementia and AD determined by expert panel consensus.ResultsFive hundred twenty-three individuals developed dementia (246 receiving placebo and 277 receiving G. biloba) with 92% of the dementia cases classified as possible or probable AD, or AD with evidence of vascular disease of the brain. Rates of dropout and loss to follow-up were low (6.3%), and the adverse effect profiles were similar for both groups. The overall dementia rate was 3.3 per 100 person-years in participants assigned to G. biloba and 2.9 per 100 person-years in the placebo group. The hazard ratio (HR) for G. biloba compared with placebo for all-cause dementia was 1.12 (95% confidence interval [CI], 0.94-1.33; P = .21) and for AD, 1.16 (95% CI, 0.97-1.39; P = .11). G. biloba also had no effect on the rate of progression to dementia in participants with MCI (HR, 1.13; 95% CI, 0.85-1.50; P = .39).ConclusionsIn this study, G. biloba at 120 mg twice a day was not effective in reducing either the overall incidence rate of dementia or AD incidence in elderly individuals with normal cognition or those with MCI. Trial Registration clinicaltrials.gov Identifier: NCT00010803.
| S-EPMC2823569 | biostudies-literature
Project description:ObjectiveInternational appeals call for interventions to prevent aggression and other behavioral problems in individuals with dementia (IWD). Aggression Prevention Training (APT), based on intervening in three contributors to development of aggression (IWD pain, IWD depression, and caregiver-IWD relationship problems) aims to reduce incidence of aggression in IWD over 1 year.DesignRandomized, controlled trial.SettingThree clinics that assess, diagnose, and treat dementia.ParticipantsTwo hundred twenty-eight caregiver-IWD dyads who screened positive for IWD pain, IWD depression, or caregiver-IWD relationship problems randomized to APT or Enhanced Usual Primary Care (EU-PC).InterventionAPT, a skills-based intervention delivered over 3 months to address pain/depression/caregiver-IWD relationship issues. EU-PC included printed material on dementia and community resources; and eight brief, weekly support calls.MeasurementsThe primary outcome was incidence of aggression over 1 year, determined by the Cohen Mansfield Agitation Inventory-Aggression Subscale. Secondary outcomes included pain, depression, caregiver-IWD relationship, caregiver burden, positive caregiving, behavior problems, and anxiety.ResultsAggression incidence and secondary outcomes did not differ between groups. However, in those screening positive for IWD depression or caregiver-IWD relationship problems, those receiving EU-PC had significant increases in depression and significant decreases in quality of the caregiver-IWD relationship, whereas those receiving APT showed no changes in these outcomes over time.ConclusionThe cost to patients, family, and society of behavioral problems in IWD, along with modest efficacy of most pharmacologic and nonpharmacologic interventions, calls for more study of novel preventive approaches.
| S-EPMC7246139 | biostudies-literature
Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:Body weight (BW) reduction through energy restriction is ineffective at impacting the obesity epidemic. Shifting from an obesity treatment to weight gain prevention focus may be more effective in decreasing the burden of adult obesity.This was a 1-year randomized controlled trial of weight gain prevention in healthy premenopausal women, aged 18-45 y, with a body mass index (BMI) of >18.5 kg/m(2). Eighty-seven women were randomized to a weight gain prevention intervention delivered by a registered dietitian (RDG) or counselor (CSG), or to a control (CON) group. Eighty-one women (mean ± SD, age: 31.4 ± 8.1 y; BW: 76.1 ± 19.0 kg; BMI: 27.9 ± 6.8 kg/m(2)) completed baseline testing and were included in intention-to-treat analyses; anthropometric, blood pressure, dietary intake and physical activity measurements and biochemical markers of health were measured every three months. Data were analyzed using repeated measures ANCOVA, with significance at P < 0.01.Sixty-two percent of women met the weight gain prevention criteria (BW change within ±3 %) after one year; this did not differ by group assignment. Body fat % was lower in the RDG versus CSG and CON groups at all intervals (P < 0.001). Systolic blood pressure increased from month 6 to 9 and decreased from month 6 to 12 in the CON group (P < 0.001), with a significant group x time interaction (P < 0.01). Estimated carbohydrate intake (%) was higher in the RDG vs. CON group at month 9 (P < 0.01); fat intake (%) was lower in the RDG vs. CON group and CSG vs. CON group at months 3 and 9, respectively (P < 0.01). Estimated fruit intake (svgs/d) was higher in the RDG vs. CON group at months 3, 6, 9 and 12 (P < 0.01), and non-meat protein sources (svgs/d) was higher in the RDG vs. CSG and CON groups at month 3 (P < 0.001). Estimated energy, macronutrient and food group intakes did not change over time.A majority of all participants maintained BW over one year and were able to do so regardless of whether they received nutrition education. Additional studies that include a variety of clinical outcomes are needed to evaluate further aspects of nutrition education on weight gain prevention and health status over the long term.
| S-EPMC4815216 | biostudies-other
Project description:ObjectivesThe present study explores the effect of visual art training on people with dementia, utilizing a randomized control trial design, in order to investigate the effects of an 8-week visual art training program on cognition. In particular, the study examines overall cognition, delayed recall, and working memory, which show deficits in people with dementia.MethodFifty-three individuals with dementia were randomly assigned into either an art training (n = 27) or usual-activity waitlist control group (n = 26). Overall cognition and delayed recall were assessed with the Montreal Cognitive Assessment (MoCA), and working memory was assessed with the Backward Digit Span task.ResultsThere were no group differences in overall cognition, or working memory, while a difference in delayed recall was undetermined, based on post-test-pre-test difference scores. Groups were comparable at baseline on all measures.ConclusionThe measures of cognition, delayed recall, and working memory used in this study were not affected by an 8-week visual art training program.Clinical trial registrationwww.ClinicalTrials.gov, identifier NCT03175822.
| S-EPMC7769761 | biostudies-literature
Project description:Although physical exercise has been suggested to influence cognitive function, previous exercise studies show inconsistent results in people with dementia.To investigate effects of exercise on cognitive function in people with dementia.The Umeå Dementia and Exercise (UMDEX) study, a cluster-randomized controlled trial, was set in 16 nursing homes in Umeå, Sweden. One hundred-and-forty-one women and 45 men with dementia; mean age of 85 y and mean Mini-Mental State Examination (MMSE) score of 15, were randomized to a High-Intensity Functional Exercise program or a seated attention control activity. Blinded assessors measured global cognitive function using the MMSE and the Alzheimer's disease Assessment Scale - Cognitive subscale (ADAS-Cog), and executive function using Verbal fluency (VF) at baseline and 4 months (directly after intervention completion), and MMSE and VF at 7 months.Linear mixed models showed no between-group effects in mean difference from baseline (95% confidence intervals, CI) at 4 months in MMSE (-0.27; 95% CI -1.4 to 0.87, p?=?0.644), ADAS-Cog (-1.04, 95% CI -4 to 1.92, p?=?0.491), or VF (-0.53, 95% CI -1.42 to 0.35, p?=?0.241) or at 7 months in MMSE (-1.15, 95% CI -2.32 to 0.03, p?=?0.056) or VF (-0.18, 95% CI -1.09 to 0.74, p?=?0.707).A 4-month, high-intensity functional exercise program had no superior effects on global cognition or executive function in people with dementia living in nursing homes when compared with an attention control activity.
| S-EPMC5611799 | biostudies-other
Project description:We hypothesized that seminal plasma, the acellular seminal fluid component, influences the endometrium stimulating the immune system and facilitating the implantation. We designed a randomized, double-blinded, placebo-controlled trial, and we used microarray analysis to evaluate differences in the endometrial transcriptomic profile after vaginal seminal plasma application. Differential gene pathways analysis showed an upregulation of pathways associated with the immune response, cell viability, proliferation and cellular movement, implantation, embryo development, oocyte maturation and angiogenesis. We compared our results with similar studies in pigs, mice and in vitro human endometrial cells and found similar and found comparable results. Our data show that seminal plasma has a positive effect on the endometrium during the implantation window.
2024-04-24 | GSE241134 | GEO
Project description:Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard nutritional approaches relying primarily on carbohydrates. We here hypothesize that a ketogenic diet improves sepsis treatment. We conducted a monocentric open-labeled randomized controlled trial enrolling 40 adult sepsis patients. Patients were randomly assigned to either ketogenic diet (KD) or standard high-carbohydrate nutrition for 14 days and followed up until day 30. The primary outcome measure was β-hydroxybutyrate (BHB) serum concentration on day 14. We assessed feasibility and safety of KD, as well as diet-associated clinical and immunological changes. The respective nutrition protocols were successfully applied, dropouts did not occur. Regression analysis revealed a greater increase in BHB concentrations from baseline to day 14 in KD patients compared to controls. Metabolic side effects were not observed under ketogenic diet. Ventilation-free, vasopressor-free, dialysis-free and ICU-free days significantly increased in patients under ketogenic diet. Transcriptome profiling of both CD4+ and CD8+ T cells at day 14 revealed substantial differential regulation of gene expression in the KD vs. the control group indicating a reduced T-cell activation and a shift towards a more regulated immunity.
2024-06-13 | GSE240861 | GEO
Project description:Background/objectivesThe Japan-multimodal intervention trial for prevention of dementia (J-MINT) is intended to verify the effectiveness of multi-domain interventions and to clarify the mechanism of cognitive improvement and deterioration by carrying out assessment of dementia-related biomarkers, omics analysis and brain imaging analysis among older adults at high risk of dementia. Moreover, the J-MINT trial collaborates with partnering private enterprises in the implementation of relevant interventional measures. This manuscript describes the study protocol.Design/settingEighteen-month, multi-centered, randomized controlled trial.ParticipantsWe plan to recruit 500 older adults aged 65-85 years with mild cognitive impairment. Subjects will be centrally randomized into intervention and control groups at a 1:1 allocation ratio using the dynamic allocation method with all subjects stratified by age, sex, and cognition.InterventionThe multi-domain intervention program includes: (1) management of vascular risk factors; (2) group-based physical exercise and self-monitoring of physical activity; (3) nutritional counseling; and (4) cognitive training. Health-related information will be provided to the control group every two months.MeasurementsThe primary and secondary outcomes will be assessed at baseline, 6-, 12-, and 18-month follow-up. The primary outcome is the change from baseline to 18 months in a global composite score combining several neuropsychological domains. Secondary outcomes include: cognitive change in each neuropsychological test, incident dementia, changes in blood and dementia-related biomarkers, changes in geriatric assessment including activities of daily living, frailty status and neuroimaging, and number of medications taken.ConclusionsThis trial that enlist the support of private enterprises will lead to the creation of new services for dementia prevention as well as to verify the effectiveness of multi-domain interventions for dementia prevention.
| S-EPMC8187136 | biostudies-literature