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Chinese Journal of Brain Diseases and Rehabilitation(Electronic Edition) ›› 2024, Vol. 14 ›› Issue (01): 14-20. doi: 10.3877/cma.j.issn.2095-123X.2024.01.003

• Clinical Research • Previous Articles     Next Articles

Analysis of the current status of domestic and international clinical trial registries for vascular cognitive impairment

Ruiyu Li, Xinliang Wang, Congcong Xu, Yanze Liu, Xuezhu Zhang()   

  1. Department of Acupuncture, Affiliated First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Traditional Chinese Medicine, Tianjin 300193, China
    College of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
  • Received:2023-03-05 Online:2024-02-15 Published:2024-02-07
  • Contact: Xuezhu Zhang
  • Supported by:
    National Natural Science Foundation of China(82174492, 30630074); Tianjin Key R&D Programme of Science and Technology Support Key Project(20YFZCSY00810)

Abstract:

Objective

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.

Methods

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.

Results

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.

Conclusion

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.

Key words: Vascular cognitive impairment, Clinical trial registration, International Clinical Trial Registration Platform, China Clinical Trial Registry, National Institutes of Health Clinical Trial Registry Platform

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