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白藜芦醇用于血管性认知障碍的脑代谢与灌注研究(REVAMP试验):一项随机、双盲、安慰剂对照试验的研究方案

REsveratrol for VAscular cognitive impairment investigating cerebral Metabolism and Perfusion (REVAMP trial): a study protocol for a randomized, double-blind, placebo-controlled trial.

作者信息

Hattori Yorito, Minami Manabu, Omae Katsuhiro, Yoshimoto Takeshi, Abe Soichiro, Yamamoto Haruko, Iida Hidehiro, Ihara Masafumi

机构信息

Department of Neurology, National Cerebral and Cardiovascular Center, Suita, Japan.

Department of Data Science, National Cerebral and Cardiovascular Center, Suita, Japan.

出版信息

Front Nutr. 2024 Apr 23;11:1359330. doi: 10.3389/fnut.2024.1359330. eCollection 2024.

DOI:10.3389/fnut.2024.1359330
PMID:38716073
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11074349/
Abstract

BACKGROUND

Carotid artery stenosis or occlusion (CASO) is a major cause of vascular cognitive impairment (VCI). There is currently no effective treatment for VCI induced by CASO. Resveratrol, a type of polyphenol, improves cognitive performance in rat CASO models via pleiotropic effects. Furthermore, we previously reported the longevity gene, , which can be activated by resveratrol, improves cognitive and cerebral blood flow impairment in mouse CASO models by activating endothelial nitric oxide synthase. However, clinical evidence remains limited.

METHODS

The REsveratrol for VAscular cognitive impairment investigating cerebral Metabolism and Perfusion (REVAMP) trial is a randomized, double-blind, placebo-controlled trial involving patients with asymptomatic CASO. Each participant will receive either 150 mg/day of resveratrol or a placebo for 35 weeks. The primary objective is to determine whether resveratrol improves cognitive impairment, as assessed using the Alzheimer's disease Assessment Scale-cognitive subscale 13. One of our secondary objectives is to determine whether resveratrol improves cerebral hemodynamic impairment as assessed via O-gas positron emission tomography. We will recruit 100 patients (50 per group).

DISCUSSION

The REVAMP trial may provide valuable insights into new therapeutic options, as multitarget neuroprotection could potentially improve cognitive function along with enhancements in cerebral hemodynamic status in patients with asymptomatic CASO.: The REVAMP trial was prospectively registered in the Japan Registry of Clinical Trials (jRCTs051230013) on April 13, 2023.

摘要

背景

颈动脉狭窄或闭塞(CASO)是血管性认知障碍(VCI)的主要原因。目前尚无针对CASO所致VCI的有效治疗方法。白藜芦醇是一种多酚类物质,通过多种效应改善大鼠CASO模型中的认知表现。此外,我们之前报道过,可被白藜芦醇激活的长寿基因,通过激活内皮型一氧化氮合酶改善小鼠CASO模型中的认知和脑血流损害。然而,临床证据仍然有限。

方法

白藜芦醇治疗血管性认知障碍研究脑代谢与灌注(REVAMP)试验是一项随机、双盲、安慰剂对照试验,纳入无症状CASO患者。每位参与者将接受每日150毫克白藜芦醇或安慰剂治疗35周。主要目标是确定白藜芦醇是否能改善认知障碍,采用阿尔茨海默病评估量表认知分量表13进行评估。我们的次要目标之一是确定白藜芦醇是否能改善通过O气体正电子发射断层扫描评估的脑血流动力学损害。我们将招募100名患者(每组50名)。

讨论

REVAMP试验可能为新的治疗选择提供有价值的见解,因为多靶点神经保护可能潜在地改善无症状CASO患者的认知功能,并增强脑血流动力学状态。:REVAMP试验于2023年4月13日在日本临床试验注册中心(jRCTs051230013)进行了前瞻性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d608/11074349/174e8c944708/fnut-11-1359330-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d608/11074349/46e0cba87686/fnut-11-1359330-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d608/11074349/f86bd8dbb572/fnut-11-1359330-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d608/11074349/174e8c944708/fnut-11-1359330-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d608/11074349/46e0cba87686/fnut-11-1359330-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d608/11074349/f86bd8dbb572/fnut-11-1359330-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d608/11074349/174e8c944708/fnut-11-1359330-g003.jpg

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