China Initiative for Multi-Domain Intervention (CHINA-IN-MUDI) to Prevent Cognitive Decline: Study Design and Progress

IF 4.3 Q2 BUSINESS
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引用次数: 0

Abstract

Background

Alzheimer’s disease (AD), the most common type of irreversible dementia, is predicted to affect 152 million people by 2050. Evidence from large-scale preventive randomized controlled trials (RCTs) on modifiable risk variables in Europe has shown that multi-domain lifestyle treatments for older persons at high risk of dementia may be practical and effective. Given the substantial differences between the Chinese and European populations in terms of demographics and living conditions, direct adoption of the European program in China remains unfeasible. Although a RCT has been conducted in China previously, its participants were mainly from rural areas in northern China and, thus, are not representative of the entire nation.There is an urgent need to establish cohorts that represent different economic, cultural, and geographical situations in order to explore implementation strategies and evaluate the effects of early multi-domain interventions more comprehensively and accurately.

Medtods

We developed an integrated intervention procedure implemented in urban neighborhood settings, namely China Initiative for Multi-Domain Intervention (CHINA-IN-MUDI). CHINA-IN-MUDI is a 2-year multicenter open-label cluster-randomised controlled trial centered around a Chinese-style multi-domain intervention to prevent cognitive decline. Participants aged 60–80 years were recruited from a nationally representative study, i.e. China Healthy Aging and Dementia Study cohort. An external harmonization process was carried out to preserve the original FINGER design. Subsequently, we standardized a series of Chinese-style intervention programs to align with cultural and socioeconomic status. Additionally, we expanded the secondary outcome list to include genomic and proteomic analyses. To enhance adherence and facilitate implementation, we leveraged an e-health application.

Results

Screening commenced in July 2022. Currently, 1,965 participants have been randomized into lifestyle intervention (n = 772) and control groups (n = 1,193). Both the intervention and control groups exhibited similar baseline characteristics. Several lifestyle and vascular risk factors were present, indicating a potential window of opportunity for intervention. The intervention will be completed by 2025.

Conclusions

This project will contribute to the evaluation of the effectiveness and safety of intervention strategies in controlling AD risk and reducing clinical events, providing a basis for public health decision-making in China.

中国预防认知功能减退多领域干预行动(CHINA-IN-MUDI):研究设计与进展
摘要 背景 阿尔茨海默病(AD)是最常见的一种不可逆转的痴呆症,预计到 2050 年将影响 1.52 亿人。欧洲针对可改变风险变量的大规模预防性随机对照试验(RCT)的证据表明,针对痴呆症高风险老年人的多领域生活方式治疗可能是切实有效的。鉴于中国与欧洲在人口结构和生活条件方面的巨大差异,在中国直接采用欧洲的方案仍不可行。目前迫切需要建立代表不同经济、文化和地理状况的队列,以便更全面、更准确地探讨早期多领域干预的实施策略和效果评估。 我们开发了一种在城市社区环境中实施的综合干预程序,即中国多领域干预行动(CHINA-IN-MUDI)。CHINA-IN-MUDI是一项为期2年的多中心开放标签群组随机对照试验,以中国式多领域干预为中心,旨在预防认知功能衰退。参与者年龄在 60-80 岁之间,来自一项具有全国代表性的研究,即中国健康老龄化与痴呆症研究队列。在保留 FINGER 原始设计的基础上,我们进行了外部协调。随后,我们根据文化和社会经济状况对一系列中国式干预方案进行了标准化。此外,我们还扩展了次要结果列表,纳入了基因组和蛋白质组分析。为了提高依从性并促进实施,我们利用了电子健康应用程序。 结果 筛选于 2022 年 7 月开始。目前,1965 名参与者被随机分为生活方式干预组(772 人)和对照组(1193 人)。干预组和对照组的基线特征相似。存在一些生活方式和血管风险因素,这表明存在潜在的干预机会。干预将于 2025 年完成。 结论 该项目将有助于评估干预策略在控制AD风险和减少临床事件方面的有效性和安全性,为中国的公共卫生决策提供依据。
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来源期刊
The Journal of Prevention of Alzheimer's Disease
The Journal of Prevention of Alzheimer's Disease Medicine-Psychiatry and Mental Health
CiteScore
9.20
自引率
0.00%
发文量
0
期刊介绍: The JPAD Journal of Prevention of Alzheimer’Disease will publish reviews, original research articles and short reports to improve our knowledge in the field of Alzheimer prevention including: neurosciences, biomarkers, imaging, epidemiology, public health, physical cognitive exercise, nutrition, risk and protective factors, drug development, trials design, and heath economic outcomes.JPAD will publish also the meeting abstracts from Clinical Trial on Alzheimer Disease (CTAD) and will be distributed both in paper and online version worldwide.We hope that JPAD with your contribution will play a role in the development of Alzheimer prevention.
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