Efficacy and Safety of Twice Daily TMBCZG in Mild to Moderate Vascular Dementia: Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Trial

The study will be a 24-week multicentre, double-blind, placebo-controlled phase Ⅱa trial with 4 treatment arms in China. Participants aged 55-80 years will be randomized to TMBCZG-high dose(84mg per day), TMBCZG- medium dose(56mg per day), TMBCZG- low dose(28mg per day) or to placebo. The primary endpoint will be VADAS-Cog and CDR-SB. Secondary outcomes included changes in MMSE and ADL. Patients' safety will be assessed by recording of adverse events, clinical examinations, electrocardiography and laboratory tests. The patients, caregivers, and investigators will be blinded to the treatment allocations.

开始日期2017-07-28

申办/合作机构

Dongzhimen Hospital

[+2]

CTR20160895 / Completed临床2期

天麻苄醇酯苷片治疗轻中度血管性痴呆的有效性和安全性的随机、双盲、安慰剂平行对照、多中心Ⅱa 期临床试验

评价天麻苄醇酯苷片治疗轻中度血管性痴呆（VaD）的有效性和安全性，探索最佳有效剂量，为IIb 期临床试验提供依据。

开始日期2017-07-24

申办/合作机构

北京科莱博医药开发有限责任公司

100 项与天麻苄醇酯苷片相关的临床结果

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100 项与天麻苄醇酯苷片相关的转化医学

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100 项与天麻苄醇酯苷片相关的专利（医药）

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项与天麻苄醇酯苷片相关的文献（医药）

2018-12-01·Medicine4区 · 医学

Protocol of a randomized controlled IIa trial

4区 · 医学

ArticleOA

作者: Tian, Jinzhou ; Zhang, Meng ; Shi, Jing ; Wang, Yongyan ; Ni, Jingnian ; Zhang, Xuekai ; Li, Ting ; Li, Yang ; Wei, Mingqing

AbstractBackground:Vascular dementia (VaD) is the 2nd most common subtype of dementia after Alzheimer disease. Currently, there are no medications approved for treating patients with VaD. Tianmabianchunzhigan (TMBCZG) tablet is an active ingredient extracted from Gastrodia that has been reported to improve memory and other cognition. And the TBMCZG has been approved clinical trial with patients with VaD by center for drug evaluation of China (CFDA). To evaluate the efficacy, safety, and tolerability of TMBCZG tablets in the treatment of mild to moderate VaD, we designed and reported the methodology for a 24-week, randomized, double-blind, parallel, placebo-controlled, multicenter trial.Methods:A total of 160 patients with mild to moderate VaD will be enrolled. After a 2-week run-in period, the eligible patients will be randomized to receive either TMBCZG high-dose group (TBMCZG 3 tablets, twice per day); TMBCZG middle-dose group (TMBCZG 2 tablets and placebo 1 tablet twice per day); TMBCZG low-dose group (TMBCZG 1 tablet and placebo 2 tablets, twice per day); placebo group (placebo 3 tablets, twice per day) for 24 weeks, with a follow-up 12 weeks after withdrawn drug treatment. The primary efficacy measurement will be the vascular dementia assessment scale-cognitive subscale and the Clinical Dementia Rating-Sum of the Boxes scale. The secondary efficacy measurements will include the mini mental state examination and activities of daily living. Adverse events will also be reported.Discussion:This randomized trial will be the 1st rigorous study on the efficacy and safety of TMBCZG tablets for treating cognitive symptoms in patients with VaD using a rational design.Trial registration:ClinicalTrials.gov NCT03230071. Registered on July 26, 2017.

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