1. 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
- Author
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Shifu Xiao, Piu Chan, Tao Wang, Zhen Hong, Shuzhen Wang, Weihong Kuang, Jincai He, Xiaoping Pan, Yuying Zhou, Yong Ji, Luning Wang, Yan Cheng, Ying Peng, Qinyong Ye, Xiaoping Wang, Yuncheng Wu, Qiumin Qu, Shengdi Chen, Shuhua Li, Wei Chen, Jun Xu, Dantao Peng, Zhongxin Zhao, Yansheng Li, Junjian Zhang, Yifeng Du, Weixian Chen, Dongsheng Fan, Yong Yan, Xiaowei Liu, Wei Zhang, Benyan Luo, Wenyuan Wu, Lu Shen, Chunfeng Liu, Peixian Mao, Qiumei Wang, Qianhua Zhao, Qihao Guo, Yongtao Zhou, Yi Li, Lijun Jiang, Wenwei Ren, Yingjun Ouyang, Yan Wang, Shuai Liu, Jianjun Jia, Nan Zhang, Zhonglin Liu, Raoli He, Tingyi Feng, Wenhui Lu, Huidong Tang, Ping Gao, Yingchun Zhang, Lanlan Chen, Lei Wang, You Yin, Qun Xu, Jinsong Xiao, Lin Cong, Xi Cheng, Hui Zhang, Dan Gao, Minghua Xia, Tenghong Lian, Guoping Peng, Xu Zhang, Bin Jiao, Hua Hu, Xueyan Chen, Yihui Guan, Ruixue Cui, Qiu Huang, Xianliang Xin, Hongjian Chen, Yu Ding, Jing Zhang, Teng Feng, Marc Cantillon, Kewei Chen, Jeffrey L. Cummings, Jian Ding, Meiyu Geng, and Zhenxin Zhang
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Sodium oligomannate ,Efficacy ,Safety ,Alzheimer’s disease ,Clinical trial ,Neurosciences. Biological psychiatry. Neuropsychiatry ,RC321-571 ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
Abstract 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
- Published
- 2021
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