Gupta Anu, Sinha Abhik, Sharma Varuna, Raina Sunil Kumar, Roy Subarna, Baidya Subrata, Anand P K, Nehra Ashima, Nilima Nilima, Khan Maroof Ahmad, Vishnu Venugopalan Y, Srivastava Padma
Neurology, All India Institute of Medical Sciences, New Delhi, India.
Division of Ageing Research, ICMR- Centre for Ageing and Mental Health, Kolkata, West Bengal, India.
BMJ Open. 2025 Jun 9;15(6):e084050. doi: 10.1136/bmjopen-2024-084050.
Treating modifiable risk factors of dementia may prevent or delay dementia cases by up to 40%. The 'Strategic Multimodal Intervention in at-risk Elderly Indians for Prevention of Dementia (SMRUTHI INDIA)' study will be conducted to establish a trial-ready cohort of elderly Indians who are at high risk of developing dementia.
The main aim of the study is to create and study a cohort of individuals at high risk of dementia in rural India, where we can do multiple intervention trials. The study uses the 'Cohort Multiple Randomised Controlled Trial' (cmRCT) design, which combines a cohort study with in-built provisions to do multiple randomised controlled trials. A large rural cohort of size 10 000 (four zones of India, through established Indian Council of Medical Research - Model Rural Health Research Units) will be followed systematically with yearly neuropsychological evaluation for 5 years (the current funding supports first 3000 participants). The study also proposes to design a multimodal 'care bundle' for the prevention of dementia, which is culturally tailored and context-specific to the Indian population. This intervention will undergo testing for feasibility in the hospital setting at the central coordinating site through a pilot randomised controlled trial (6 months, 30 participants). In parallel, the care bundle will be culturally and linguistically adapted and pilot-tested in 20 participants in each zone. The final curated care bundle (first intervention that is planned) will then be tested for efficacy in phase 2 of the SMRUTHI INDIA cmRCT cohort.
The study has received ethical clearance at the central coordinating site and at each of the four clinical sites by the Institute Research Committee of each site. The outcomes of the study will be disseminated to various target audiences, including research participants, general public, scientific community and policy makers through national and international conferences and events, social media, various community engagement activities and publication in peer-reviewed journals.
The study protocol is registered in the Clinical Trial Registry of India (CTRI/2024/01/061172).
治疗痴呆症的可改变风险因素可预防或延缓高达40%的痴呆症病例。将开展“印度高危老年人预防痴呆症的战略多模式干预（SMRUTHI INDIA）”研究，以建立一个准备好进行试验的、患痴呆症风险高的印度老年人群体。
该研究的主要目的是在印度农村创建并研究一个患痴呆症风险高的个体群体，在那里我们可以进行多项干预试验。该研究采用“队列多重随机对照试验”（cmRCT）设计，将队列研究与进行多项随机对照试验的内置规定相结合。将对一个规模为10000人的大型农村队列（通过印度医学研究理事会既定的农村卫生研究模式单位在印度四个地区选取）进行为期5年的系统跟踪，并每年进行神经心理学评估（目前的资金支持前3000名参与者）。该研究还提议设计一个预防痴呆症的多模式“护理包”，该护理包针对印度人群进行了文化定制且因地制宜。此干预措施将通过一项试点随机对照试验（6个月，30名参与者）在中央协调地点的医院环境中进行可行性测试。同时，护理包将在每个地区的20名参与者中进行文化和语言调整及试点测试。然后，最终精心策划的护理包（计划的首次干预措施）将在SMRUTHI INDIA cmRCT队列的2期进行疗效测试。
该研究已获得各研究地点的机构研究委员会在中央协调地点及四个临床地点的伦理批准。研究结果将通过国内和国际会议及活动、社交媒体、各种社区参与活动以及在同行评审期刊上发表，传播给包括研究参与者、普通公众、科学界和政策制定者在内的各类目标受众。
该研究方案已在印度临床试验注册中心注册（CTRI/2024/01/061172）。
