Chinese Journal of Contemporary Neurology and Neurosurgery ›› 2025, Vol. 25 ›› Issue (5): 363-366. doi: 10.3969/j.issn.1672-6731.2025.05.001

• Special Topic • Previous Articles     Next Articles

Key issues and advances in clinical trial design for the treatment of cerebral small vessel disease

Yi-cheng ZHU, Fei HAN*()   

  1. Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China
  • Received:2025-03-15 Online:2025-05-25 Published:2025-06-05
  • Contact: Fei HAN
  • Supported by:
    Noncommunicable Chronic Diseases-National Science and Technology Major Project(2023ZD0504900)

脑小血管病治疗临床试验设计的关键问题与进展

朱以诚, 韩菲*()   

  1. 100730 中国医学科学院 北京协和医学院 北京协和医院神经科
  • 通讯作者: 韩菲
  • 基金资助:
    四大慢病重大专项(2023ZD0504900)

Abstract:

Cerebral small vessel disease (CSVD) is a major cause of stroke and dementia, with its treatment paradigm shifting from conventional risk factor management to targeted pathophysiological interventions. This article reviews the current landscape and key challenges in CSVD treatment research, focusing on patient selection, optimization of study endpoints, and development of targeted therapeutic strategies. Additionally, it explores the FINESSE framework, which aims to refine CSVD clinical trial design and accelerate advancements in treatment.

Key words: Cerebral small vessel diseases, Therapy, Clinical trial, Research design, Review

摘要:

脑小血管病是脑卒中和痴呆的主要病因之一,其治疗策略正从传统的危险因素管理向靶向病理生理学机制的精准干预转型。本文聚焦脑小血管病治疗临床试验设计的现状与挑战,重点探讨研究人群选择、研究终点优化及治疗靶点探索,并解读FINESSE框架,以优化脑小血管病的临床试验设计,推动其治疗研究的深入发展。

关键词: 大脑小血管疾病, 治疗, 临床试验, 研究设计, 综述