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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

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收录情况： ◇ SCIE ◇ SSCI

作者：
Xiao, Shifu[1,2,*1] * ; 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[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,*2] ; Zhang, Zhenxin[36,*3] ;
机构： [1]Shanghai Jiao Tong Univ, Dept Geriatr Psychiat, Shanghai Mental Hlth Ctr, Sch Med, Shanghai, Peoples R China [2]Shanghai Jiao Tong Univ, Alzheimers Dis & Related Disorders Ctr, 600 South Wan Ping Rd, Shanghai 200030, Peoples R China [3]Capital Med Univ, Xuanwu Hosp, Beijing, Peoples R China [4]Fudan Univ, Huashan Hosp, Shanghai, Peoples R China [5]Shandong Univ, Qilu Hosp, Jinan, Peoples R China [6]Sichuan Univ, West China Hosp, Chengdu, Peoples R China [7]Wenzhou Med Univ, Affiliated Hosp 1, Wenzhou, Peoples R China [8]South China Univ Technol, Guangzhou Peoples Hosp 1, Sch Med, Guangzhou, Peoples R China [9]Nankai Univ, Tianjin Huanhu Hosp, Huanhu Hosp, Tianjin, Peoples R China [10]Peoples Liberat Army Gen Hosp, Dept Geriatr Neurol, Beijing, Peoples R China [11]Tianjin Med Univ Gen Hosp, Dept Neurol, Tianjin, Peoples R China [12]Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Guangzhou, Peoples R China [13]Fujian Med Univ, Union Hosp, Fuzhou, Peoples R China [14]Shanghai Jiao Tong Univ, Sch Med, Dept Neurol, Shanghai Gen Hosp, Shanghai, Peoples R China [15]Xi An Jiao Tong Univ, Dept Neurol, Affiliated Hosp 1, Xian, Peoples R China [16]Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Dept Neurol, Shanghai, Peoples R China [17]Beijing Hosp, Beijing, Peoples R China [18]Zhejiang Univ, Sch Med, Dept Psychiat, Sir Run Run Shaw Hosp, Hangzhou, Peoples R China [19]Key Lab Med Neurobiol Zhejiang Prov, Hangzhou, Peoples R China [20]Northern Jiangsu Peoples Hosp, Yangzhou, Jiangsu, Peoples R China [21]China Japan Friendship Hosp, Dept Neurol, Beijing, Peoples R China [22]Shanghai Changzheng Hosp, Shanghai, Peoples R China [23]Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Shanghai, Peoples R China [24]Wuhan Univ, Zhongnan Hosp, Dept Neurol, Wuhan, Peoples R China [25]Shandong Univ, Shandong Prov Hosp, Jinan, Peoples R China [26]Jiangsu Prov Peoples Hosp, Nanjing, Peoples R China [27]Peking Univ Third Hosp, Beijing, Peoples R China [28]Chongqing Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China [29]Wuxi Mental Hlth Ctr, Dept Geriatr Psychiat, Wuxi, Jiangsu, Peoples R China [30]Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R China [31]Zhejiang Univ, Sch Med, Affiliated Hosp1, Hangzhou, Peoples R China [32]Tongji Univ, Tongji Hosp, Shanghai, Peoples R China [33]Cent South Univ, Xiangya Hosp, Changsha, Peoples R China [34]Soochow Univ, Affiliated Hosp 2, Suzhou, Peoples R China [35]Capital Med Univ, Beijing An Ding Hosp, Beijing, Peoples R China [36]Peking Union Med Coll Hosp, 1 Shuaifuyuan, Beijing 100730, Peoples R China [37]Shanghai Jiao Tong Univ, Med X Res Inst, Shanghai, Peoples R China [38]Shanghai Green Valley Pharmaceut Co Ltd, 421 Niudun Rd, Shanghai, Peoples R China [39]Banner Alzheimers Inst, Phoenix, AZ USA [40]Univ Nevada, Dept Brain Hlth, Sch Integrated Hlth Sci, Chamberrs Grundy Ctr Transformat Neurosci, Las Vegas, NV 89154 USA [41]Chinese Acad Sci, Shanghai Inst Mat Medica, State Key Lab Drug Res, 555 Chong Zhi Rd, Nevada, Peoples R China
出处：
DOI： 10.1186/s13195-021-00795-7
ISSN：

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.

基金：
Shanghai Green Valley Pharmaceuticals (SHGV) and National Science and Technology Major Project for Investigational New Drugs (2011ZX09101-003-01, 2015ZX09101003, 2018ZX09711002-015).
语种：
外文
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2020]版：
大类 | 2 区 医学
小类 | 2 区 临床神经病学 2 区 神经科学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 临床神经病学 1 区 神经科学
JCR分区：
出版当年[2019]版：
Q1 NEUROSCIENCES Q1 CLINICAL NEUROLOGY
最新[2023]版：
Q1 CLINICAL NEUROLOGY Q1 NEUROSCIENCES

影响因子： 最新[2023版] 最新五年平均 出版当年[2019版] 出版当年五年平均 出版前一年[2018版] 出版后一年[2020版]

第一作者：
第一作者机构： [1]Shanghai Jiao Tong Univ, Dept Geriatr Psychiat, Shanghai Mental Hlth Ctr, Sch Med, Shanghai, Peoples R China [2]Shanghai Jiao Tong Univ, Alzheimers Dis & Related Disorders Ctr, 600 South Wan Ping Rd, Shanghai 200030, Peoples R China [*1]Shanghai Jiao Tong Univ, Dept Geriatr Psychiat, Shanghai Mental Hlth Ctr, Sch Med, Shanghai, Peoples R China
通讯作者：
通讯机构： [1]Shanghai Jiao Tong Univ, Dept Geriatr Psychiat, Shanghai Mental Hlth Ctr, Sch Med, Shanghai, Peoples R China [*1]Shanghai Jiao Tong Univ, Dept Geriatr Psychiat, Shanghai Mental Hlth Ctr, Sch Med, Shanghai, Peoples R China [*2]Fudan Univ, Huashan Hosp, Shanghai, Peoples R China [*3]Peking Union Med Coll Hosp, 1 Shuaifuyuan, Beijing 100730, Peoples R China [4]Fudan Univ, Huashan Hosp, Shanghai, Peoples R China [36]Peking Union Med Coll Hosp, 1 Shuaifuyuan, Beijing 100730, Peoples R China
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):62.doi:10.1186/s13195-021-00795-7.
APA：
Xiao, Shifu,Chan, Piu,Wang, Tao,Hong, Zhen,Wang, Shuzhen...&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):62

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