CerebrAlcare Pills on CereBral Small VesseL DiseasE (CABLE) trial: rationale and design.

IF 4.9 1区 医学
Mengyuan Zhou, Yutian Gong, Shangrong Han, Meiping Wang, Wenping Gu, Hui-Sheng Chen, Wenxu Zheng, Kai Feng, Dan Wang, Hang Li, Zhidong Zheng, Yuesong Pan, Weiqi Chen, Yilong Wang
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引用次数: 0

Abstract

Rationale: Cerebral small vessel disease (CSVD) is responsible for 25% of ischaemic strokes and 45% of dementia cases. Currently, therapies targeting individual mechanisms have not shown significant efficacy. As CSVD involves multiple pathophysiological mechanisms, Cerebralcare pills, a traditional Chinese medicine with multiple pharmacological mechanisms, may be effective in treating cognitive dysfunction in CSVD.

Aims: The objective of this study was to assess the efficacy of Cerebralcare pills in improving cognitive dysfunction (measured by Montreal Cognitive Assessment (MoCA)) in patients with CSVD.

Sample size estimates: A sample size of 114 patients with CSVD (57 in each group) will allow 2.74 points (with an SE of 0.56 points) difference between two groups on the MoCA score with 5% significance, 80% power and assuming a 10% dropout rate.

Methods and design: This is a randomised double-blind, multicentre, placebo-controlled trial involving individuals with mild cognitive impairment (MoCA score ranging from 16 to 24) associated with CSVD. CSVD was defined by the presence of white matter hyperintensities consistent with lacunar infarcts or the presence of more than two vascular risk factors. Participants were randomised 1:1 to orally take 5 g of Cerebralcare pills or placebo twice a day for 6 months.

Study outcomes: The primary outcome measure is the change in MoCA score at 6 months. Secondary outcome measures include the assessment of clinical manifestations, cognitive performance, conventional MRI markers, blood-brain barrier permeability and proteomics over a follow-up period of 6 months and 12 months.

Discussion: The objective of this trial is to evaluate the efficacy of Cerebralcare pills in improving cognitive dysfunction associated with CSVD. Additionally, the trial aims to provide insights into the pathological processes involved in this condition.

Trial registration number: NCT05578521.

脑健丸治疗脑血管疾病(CABLE)试验:理论基础和设计。
理由:脑血管疾病(CSVD)是25%的缺血性中风和45%的痴呆病例的原因。目前,针对个体机制的治疗尚未显示出显著的疗效。由于CSVD涉及多种病理生理机制,脑保健丸作为一种具有多种药理机制的中药,可能有效治疗CSVD的认知功能障碍。目的:本研究的目的是评估脑保健丸改善CSVD患者认知功能障碍(通过蒙特利尔认知评估(MoCA)测量)的疗效。样本量估计:114例CSVD患者(每组57例)的样本量将允许两组之间的MoCA评分差异2.74分(SE为0.56分),显著性为5%,功率为80%,假设退学率为10%。方法和设计:这是一项随机、双盲、多中心、安慰剂对照试验,涉及与CSVD相关的轻度认知障碍(MoCA评分范围从16到24)患者。CSVD的定义是存在与腔隙性梗死一致的白质高信号或存在两种以上的血管危险因素。参与者按1:1随机分组,每天两次口服5克脑保健药片或安慰剂,持续6个月。研究结果:主要观察指标是6个月时MoCA评分的变化。次要结局指标包括6个月和12个月随访期间的临床表现、认知表现、常规MRI标志物、血脑屏障通透性和蛋白质组学评估。讨论:本试验的目的是评估脑保健丸改善心血管疾病相关认知功能障碍的疗效。此外,该试验旨在提供有关这种情况的病理过程的见解。试验注册号:NCT05578521。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Investigative Medicine
Journal of Investigative Medicine MEDICINE, GENERAL & INTERNALMEDICINE, RESE-MEDICINE, RESEARCH & EXPERIMENTAL
自引率
0.00%
发文量
111
期刊介绍: Journal of Investigative Medicine (JIM) is the official publication of the American Federation for Medical Research. The journal is peer-reviewed and publishes high-quality original articles and reviews in the areas of basic, clinical, and translational medical research. JIM publishes on all topics and specialty areas that are critical to the conduct of the entire spectrum of biomedical research: from the translation of clinical observations at the bedside, to basic and animal research to clinical research and the implementation of innovative medical care.
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