首页 / 院系成果 / 成果详情页

A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer's dementia  期刊论文   WOS高被引论文

  • 编号：
    a970fe05-0ea7-4b73-a77f-1c2a0275de83
  • 作者：
    Xiao, Shifu[1,2];Chan, Piu[3];Wang, Tao[1,2];Hong, Zhen[4];Wang, Shuzhen[5];Kuang, Weihong[6];He, Jincai[7];Pan, Xiaoping[8];Zhou, Yuying[9];Ji, Yong[9];Wang, Luning[10];Cheng, Yan[11];Peng, Ying[12];Ye, Qinyong[13];Wang, Xiaoping[14];Wu, Yuncheng[14];Qu, Qiumin[15];Chen, Shengdi[16];Li, Shuhua[17];Chen, Wei[18,19];Xu, Jun[20];Peng, Dantao(彭丹涛)[21]Zhao, Zhongxin[22];Li, Yansheng[23];Zhang, Junjian[24];Du, Yifeng[25];Chen, Weixian[26];Fan, Dongsheng[27];Yan, Yong[28];Liu, Xiaowei[29];Zhang, Wei[30];Luo, Benyan[31];Wu, Wenyuan[32];Shen, Lu[33];Liu, Chunfeng[34];Mao, Peixian[35];Wang, Qiumei[36];Zhao, Qianhua[4];Guo, Qihao[4];Zhou, Yongtao[3];Li, Yi[5];Jiang, Lijun[6];Ren, Wenwei[7];Ouyang, Yingjun[8];Wang, Yan[9];Liu, Shuai[9];Jia, Jianjun[10];Zhang, Nan[11];Liu, Zhonglin[12];He, Raoli[13];Feng, Tingyi[14];Lu, Wenhui[15];Tang, Huidong[16];Gao, Ping[17];Zhang, Yingchun[18,19];Chen, Lanlan[20];Wang, Lei[21];Yin, You[22];Xu, Qun[23];Xiao, Jinsong[24];Cong, Lin[25];Cheng, Xi[26];Zhang, Hui[27];Gao, Dan[28];Xia, Minghua[29];Lian, Tenghong[30];Peng, Guoping[31];Zhang, Xu[32];Jiao, Bin[33];Hu, Hua[34];Chen, Xueyan[35];Guan, Yihui[4];Cui, Ruixue[36];Huang, Qiu[37];Xin, Xianliang[38];Chen, Hongjian[38];Ding, Yu[38];Zhang, Jing[38];Feng, Teng[38];Cantillon, Marc[38];Chen, Kewei[39];Cummings, Jeffrey L.[40];Ding, Jian[41];Geng, Meiyu[4];Zhang, Zhenxin[36];
  • 语种：
    英文
  • 期刊：
    ALZHEIMERS RESEARCH & THERAPY ISSN：1758-9193 2021 年 13 卷 1 期 ; MAR 17
  • 收录：
     
  • 关键词：
    Sodium oligomannate Efficacy Safety Alzheimer's disease Clinical trial
  • 摘要：

    Background: New therapies are urgently needed for Alzheimer's disease (AD). Sodium oligomannate (GV-971) is a marine derived oligosaccharide with a novel proposed mechanism of action. The first phase 3 clinical trial of GV-971 has been completed in China.
    Methods: We conducted a phase 3, double-blind, placebo-controlled trial in participants with mild-to-moderate AD to assess GV-971 efficacy and safety. Participants were randomized to placebo or GV-971 (900 mg) for 36 weeks. The primary outcome was the drug-placebo difference in change from baseline on the 12-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog12). Secondary endpoints were drug-placebo differences on the Clinician's Interview-Based Impression of Change with caregiver input (CIBIC+), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, and Neuropsychiatric Inventory (NPI). Safety and tolerability were monitored.
    Results: A total of 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time point, measurable at the week 4 visit and continuing throughout the trial. The difference between the groups in change from baseline was - 2.15 points (95% confidence interval, - 3.07 to - 1.23; p < 0.0001; effect size 0.531) after 36 weeks of treatment. Treatment-emergent adverse event incidence was comparable between active treatment and placebo (73.9%, 75.4%). Two deaths determined to be unrelated to drug effects occurred in the GV-971 group.
    Conclusions: GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial. GV-971 was safe and well-tolerated.

  • 推荐引用方式
    GB/T 7714：
    Xiao Shifu,Chan Piu,Wang Tao, et al. A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer's dementia [J].ALZHEIMERS RESEARCH & THERAPY,2021,13(1).
  • APA：
    Xiao Shifu,Chan Piu,Wang Tao,Hong Zhen,&Zhang Zhenxin.(2021).A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer's dementia .ALZHEIMERS RESEARCH & THERAPY,13(1).
  • MLA：
    Xiao Shifu, et al. "A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer's dementia" .ALZHEIMERS RESEARCH & THERAPY 13,1(2021).
  • 条目包含文件：
    文件类型：PDF,文件大小：
    正在加载全文
浏览次数：128 下载次数：0
分享到：
浏览次数：128
下载次数：0
打印次数：0

网站总浏览量： 次   

Copyright © 中日友好医院

技术支持：北京同舟云网络信息技术有限公司

浏览器支持: Google Chrome   火狐   360浏览器极速模式(8.0+极速模式) 
返回顶部