基于世界卫生组织国际临床试验注册平台（ICTRP）、中国临床试验注册中心（ChiCTR）和美国国立卫生研究院临床试验注册平台（ClinicalTrials.gov）数据，对血管性认知障碍（VCI）临床试验注册情况及发展趋势进行总结和分析。

检索ICTRP、ChiCTR及ClinicalTrials.gov平台自建库以来至2022年12月31日VCI的临床试验资料。由2名研究者独立筛选文献、提取资料后，从纳入试验的注册概况、研究设计、干预措施、观察指标等方面进行描述性分析。

经筛选，最终纳入177项VCI相关临床试验，整体注册情况呈波动式增长趋势，ChiCTR（67项）和ClinicalTrials.gov（87项）是其主要注册平台，中国（110项）在申请VCI相关临床试验中占主要地位，北京（38项）、上海（11项）、湖北（8项）及台湾（8项）为我国VCI研究主要热点省市；该领域研究以干预性研究为主（132项），随机、盲法运用较普遍，设计模式以随机平行对照（110项）为主，各研究间样本量差异较大，且大多研究未注明临床试验阶段（81项），干预措施以药物疗法对比安慰剂为主，非药物疗法研究占比较少，观察指标主要采用认知能力量表及日常生活质量测评量表。

目前VCI研究处于上升发展阶段，非痴呆型VCI、血管性轻度认知障碍研究及非药物疗法研究待拓展空间较大，国际及国内地区间应加强合作以产出更多VCI研究高质量循证证据。

To analyze the registration status and development trend of clinical trials for vascular cognitive impairment (VCI) based on data from the WHO International Clinical Trials Registry Platform (ICTRP), China Clinical Trials Registry (ChiCTR) and National Institutes of Health Clinical Trial Registry Platform (ClinicalTrials.gov) registry platform.

The clinical trial information of VCI on ICTRP, ChiCTR, and ClinicalTrials.gov platforms since the creation of the databases until December 31, 2022. After the literature was independently screened and data extracted by 2 investigators, descriptive analyses were conducted in terms of enrollment profiles, study design, interventions, and observational indicators of the included trials.

After screening, 177 VCI-related clinical trials were finally included, and the overall enrolment showed a fluctuating growth trend. ChiCTR (67 trials) and ClinicalTrials.gov (87 trials) were the main enrolment platforms. China (110 trials) dominated the applications for VCI-related clinical trials, with Beijing (38 trials), Shanghai (11 trials), Hubei (8 trials) and Taiwan (8 trials) as the main hotspot provinces and cities for VCI research in China. Research in this field is dominated by interventional studies (132 trials). Randomised and blinded methods were more commonly used. The design mode was mainly randomised parallel control (110 trials). The sample size varied widely among studies, and most of them did not specify the clinical trial stage (81 trials). Interventions were predominantly pharmacological therapies versus placebo, with a relatively small proportion of non-pharmacological therapy studies. The main observational indicators were cognitive performance scales and quality of daily life scales.

At present, research on VCI is on the rise, and there is much room for research on VCI not dementia, vascular mild cognitive impairment disease types and non-pharmacological therapies. China should continue to strengthen international and domestic inter-regional cooperation to produce more high-quality evidence-based evidence for VCI.