PDF(Pubmed)
Abstract：
BACKGROUND: The efficacy of multitarget neuroprotective drug DL-3-n-butylphthalide (NBP) in improving cognitive function has been confirmed in patients with vascular cognitive impairment without dementia. However, its efficacy in patients with symptomatic predementia phase of Alzheimer\'s disease remains uncertain. This study aims to evaluate the efficacy and safety of NBP in improving cognitive function in patients with mild cognitive impairment (MCI) through a clinical randomised controlled trail.
METHODS: This study is a 12-month, randomised, double-blind, placebo-controlled, multicentric trial, involving 270 patients with MCI. Subjects are randomly assigned to receive either NBP soft capsule (200 mg, three times per day) or placebo with an allocation ratio of 1:1. The efficacy and safety of NBP are assessed by comparing the results of neuropsychological, neuroimaging and laboratory tests between the two groups. The primary endpoint is the change in Alzheimer\'s Disease Assessment Scale-Cognitive Subscale after 12 months. All patients will be monitored for adverse events.
BACKGROUND: This study involving human participants has been reviewed and approved by Ethics Committee of Xuan Wu Hospital (No.2017058). The participants provide their written informed consent to participate in this study. Results will be published in peer-reviewed medical journals and disseminated to healthcare professionals at local and international conferences.
METHODS: V 3.0, 3 September 2022.
BACKGROUND: ChiCTR1800018362.
METHODS: This study is a 12-month, randomised, double-blind, placebo-controlled, multicentric trial, involving 270 patients with MCI. Subjects are randomly assigned to receive either NBP soft capsule (200 mg, three times per day) or placebo with an allocation ratio of 1:1. The efficacy and safety of NBP are assessed by comparing the results of neuropsychological, neuroimaging and laboratory tests between the two groups. The primary endpoint is the change in Alzheimer\'s Disease Assessment Scale-Cognitive Subscale after 12 months. All patients will be monitored for adverse events.
BACKGROUND: This study involving human participants has been reviewed and approved by Ethics Committee of Xuan Wu Hospital (No.2017058). The participants provide their written informed consent to participate in this study. Results will be published in peer-reviewed medical journals and disseminated to healthcare professionals at local and international conferences.
METHODS: V 3.0, 3 September 2022.
BACKGROUND: ChiCTR1800018362.
摘要：
背景：多靶点神经保护药物DL-3-正丁苯酞（NBP）改善认知功能的疗效已在无痴呆的血管性认知障碍患者中得到证实。然而,其在阿尔茨海默病症状性痴呆前期患者中的疗效仍不确定。本研究旨在通过临床随机对照试验评估NBP改善轻度认知障碍（MCI）患者认知功能的有效性和安全性。
方法：本研究为期12个月，随机化，双盲,安慰剂对照,多中心试验,涉及270名MCI患者。受试者被随机分配接受NBP软胶囊(200mg，每天三次）或安慰剂，分配比例为1：1。通过比较神经心理学的结果来评估NBP的有效性和安全性，两组之间的神经影像学和实验室检查。主要终点是12个月后阿尔茨海默病评估量表-认知子量表的变化。将监测所有患者的不良事件。
背景：这项涉及人类参与者的研究已获得宣武医院伦理委员会的审查和批准（No.2017058）。参与者提供他们参与本研究的书面知情同意书。结果将在同行评审的医学期刊上发表，并在本地和国际会议上传播给医疗保健专业人员。
方法：V3.0，2022年9月3日。
背景：ChiCTR1800018362。
方法：本研究为期12个月，随机化，双盲,安慰剂对照,多中心试验,涉及270名MCI患者。受试者被随机分配接受NBP软胶囊(200mg，每天三次）或安慰剂，分配比例为1：1。通过比较神经心理学的结果来评估NBP的有效性和安全性，两组之间的神经影像学和实验室检查。主要终点是12个月后阿尔茨海默病评估量表-认知子量表的变化。将监测所有患者的不良事件。
背景：这项涉及人类参与者的研究已获得宣武医院伦理委员会的审查和批准（No.2017058）。参与者提供他们参与本研究的书面知情同意书。结果将在同行评审的医学期刊上发表，并在本地和国际会议上传播给医疗保健专业人员。
方法：V3.0，2022年9月3日。
背景：ChiCTR1800018362。
