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Shanghai cognitive intervention of mild cognitive impairment for delaying progress with longitudinal evaluation-a prospective, randomized controlled study (SIMPLE): rationale, design, and methodology.

ABSTRACT: BACKGROUND:Mild cognitive impairment is an early stage of Alzheimer's disease. Increasing evidence has indicated that cognitive training could improve cognitive abilities of MCI patients in multiple cognitive domains, making it a promising therapeutic approach for MCI. However, the effect of long-time training has not been widely explored. It is also necessary to evaluate the extent how it could reduce the convertion rate from MCI to AD. METHODS/DESIGN:The SIMPLE study is a multicenter, randomized, single-blind prospective clinical trial assessing the effects of computerized cognitive training on different cognitive domains in MCI patients. It is carried out in 7 centers in China. The study population includes patients aged 50-85, and they are randomly allocated to the training or control group. The primary outcome is to compare the conversion rate of MCI within 36-month follow-up. Structural and functional MRI will be used to interpret the effect of cognitive training. The cognitive training comprises a variety of games related with cognitive domains such as attention, memory, visualspatial ability and executive function. We cautiously set 50% reduction in the rate of conversion as estimated effect. With 80-90% statistical power and 12% as the overall probability of conversion within the study period, 600-800 patients are finally required in the study. The first patent has been recruited in April 2017. DISCUSSION:Previous studies suggested the benefit of cognitive training for MCI, but neither long-time nor Chinese culture were investigated. The SIMPLE designs and utilizes an improved computerized cognitive training approach and assesses its effects on MCI progress. In addition, neural activities explaining the effects on cognition function changes will be revealed, which could in turn to imply more useful therapeutic approaches. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03119051.

SUBMITTER: Lin Y

PROVIDER: S-EPMC6057042 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Shanghai cognitive intervention of mild cognitive impairment for delaying progress with longitudinal evaluation-a prospective, randomized controlled study (SIMPLE): rationale, design, and methodology.

Lin Yiqi Y Li Binyin B Tang Huidong H Xu Qun Q Wu Yuncheng Y Cheng Qi Q Li Chunbo C Xiao Shifu S Shen Lu L Tang Weiguo W Yu Hui H He Naying N Lin Huawei H Yan Fuhua F Cao Wenwei W Yang Shilin S Liu Ye Y Zhao Wei W Lu Dong D Jiao Bin B Xiao Xuewen X Zhou Lin L Chen Shengdi S

BMC neurology 20180724 1

<h4>Background</h4>Mild cognitive impairment is an early stage of Alzheimer's disease. Increasing evidence has indicated that cognitive training could improve cognitive abilities of MCI patients in multiple cognitive domains, making it a promising therapeutic approach for MCI. However, the effect of long-time training has not been widely explored. It is also necessary to evaluate the extent how it could reduce the convertion rate from MCI to AD.<h4>Methods/design</h4>The SIMPLE study is a multic ...[more]

PMID: 30041656

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Project description:BACKGROUND/OBJECTIVE:In population studies, most individuals with mild cognitive impairment (MCI) do not progress to dementia in the near term, but rather remain stable MCI or revert to normal cognition. Here, we characterized MCI subgroups with different outcomes over 5 years. SETTING/PARTICIPANTS:A population-based cohort (N=1603). MEASUREMENTS:Clinical Dementia Rating (CDR); self-reported medical conditions, subjective cognitive concerns, self-rated health, depressive symptoms, blood pressure, medications, blood pressure, APOE genotype, cognitive domain composite scores. DESIGN:We compared 3 MCI subgroups who progressed to dementia (n=86), stabilized at MCI (n=384), or reverted to normal (n=252), to those who remained consistently normal (n=881), defining MCI as CDR = 0.5 and dementia as CDR?1. Using multinomial logistic regression models adjusted for demographics, we examined the associations of each group with selected baseline characteristics. RESULTS:With the normal group for reference, worse subjective cognitive concerns, functional impairments, self-rated health, and depressive symptoms were associated with being in any MCI group. Taking more prescription medications was associated with being in the stable MCI and reverter groups; diabetes and low diastolic blood pressure were associated with stable MCI. The APOE4 genotype was associated with stable and progressive MCI; stroke was associated with progressive MCI. All MCI subgroups were likely to have lower mean composite scores in all cognitive domains and more operationally defined impairments in attention, language, and executive function; reverters were more likely to lack memory and visuospatial impairments. CONCLUSIONS:MCI subgroups with different 5-year outcomes had some distinct characteristics suggesting different underlying causes. The progressors, unlike the reverters, had a profile broadly typical of Alzheimer's disease; the stable MCIs had other, including vascular, morbidity. These data shed light on the heterogeneity of MCI in the population. J Am Geriatr Soc 67:232-238, 2019.

Project description:A sensitive marker for monitoring progression of early Alzheimer's disease would help to develop and test new therapeutic strategies. The present study is aimed at investigating brain metabolism changes over time, as a potential monitoring marker, in patients with amnestic mild cognitive impairment, according to their clinical outcome (converters or non-converters), and in relation to their cognitive decline. Seventeen amnestic mild cognitive impairment patients underwent magnetic resonance imaging and 18FDG-positron emission tomography scans both at inclusion and 18 months later. Baseline and follow-up positron emission tomography data were corrected for partial volume effects and spatially normalized using magnetic resonance imaging data, scaled to the vermis and compared using SPM2. 'PET-PAC' maps reflecting metabolic per cent annual changes were created for correlation analyses with cognitive decline. In the whole sample, the greatest metabolic decrease concerned the posterior cingulate-precuneus area. Converters had significantly greater metabolic decrease than non-converters in two ventro-medial prefrontal areas, the subgenual (BA25) and anterior cingulate (BA24/32). PET-PAC in BA25 and BA24/32 combined allowed complete between-group discrimination. BA25 PET-PAC significantly correlated with both cognitive decline and PET-PAC in the hippocampal region and temporal pole, while BA24/32 PET-PAC correlated with posterior cingulate PET-PAC. Finally, the metabolic change in BA8/9/10 was inversely related to that in BA25 and showed relative increase with cognitive decline, suggesting that compensatory processes may occur in this dorso-medial prefrontal region. The observed ventro-medial prefrontal disruption is likely to reflect disconnection from the hippocampus, both indirectly through the cingulum bundle and posterior cingulate cortex for BA24/32, and directly through the uncinate fasciculus for BA25. Altogether, our findings emphasize the potential of 18FDG-positron emission tomography for monitoring early Alzheimer's disease progression.

Project description:BackgroundRecent evidence from cross-sectional and longitudinal studies supports the hypothesis that sarcopenia is associated with worsening cognitive function. However, primary evidence largely comes from high-income countries, whereas in low- and middle-income countries, this association has been underexplored. This study aimed to estimate the longitudinal association between sarcopenia and mild cognitive impairment in a sample of older Mexican adults.MethodsData come from the three waves of the World Health Organization (WHO) Study on Global AGEing and Adult Health (SAGE) in Mexico (2009, 2014, 2017). Four hundred ninety-six older adults, aged ≥50, were included. Sarcopenia was defined as having low muscle quantity and either/both slow gait speed and weak handgrip strength. Mild cognitive impairment was determined based on the recommendations of the National Institute on Aging-Alzheimer's Association. Cognitive function was evaluated by a composite cognitive score of five different cognitive tests: immediate and delayed recall, forward and backward digit span and semantic verbal fluency. Three-level mixed-effects models (logistic and linear) were used to estimate the longitudinal associations between sarcopenia, mild cognitive impairment and cognitive function.ResultsThe prevalence of mild cognitive impairment (8.9%, 12.9%, 16.0%) and sarcopenia (10.5%, 20.7%, 23.3%) showed a significant temporal increase for Waves 1, 2 and 3 (P-value < 0.01, respectively). The presence of sarcopenia was significantly associated with mild cognitive impairment (OR = 1.74; CI95% 1.02, 2.96; P = 0.04) and worse cognitive function (β = -0.57; CI95% -0.93, -0.21; P < 0.01). We observed significant associations between sarcopenia and immediate verbal recall (β = -0.14; CI95% -0.28, -0.01; P = 0.04), delayed verbal recall (β = -0.12; CI95% -0.23, -0.01; P = 0.03) and semantic verbal fluency (β = -0.17; CI95% -0.28, -0.05; P = 0.01). The prevalence of mild cognitive impairment increased at an annual rate of 0.8% for non-sarcopenic older adults, but nearly 1.5% for sarcopenic adults.ConclusionsSignificant longitudinal associations were observed between sarcopenia, mild cognitive impairment and cognitive function among older Mexican adults. Public health strategies, including policy research and clinical interventions, must be implemented in low- and middle-income countries in order to reduce or delay the onset of sarcopenia and thus improve population-level cognitive health among older adults.

Dataset Information

Shanghai cognitive intervention of mild cognitive impairment for delaying progress with longitudinal evaluation-a prospective, randomized controlled study (SIMPLE): rationale, design, and methodology.

Publications

Shanghai cognitive intervention of mild cognitive impairment for delaying progress with longitudinal evaluation-a prospective, randomized controlled study (SIMPLE): rationale, design, and methodology.

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