Dataset Information

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.

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 < 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.

Trial registration

ClinicalTrials.gov, NCT0229391 5. Registered on November 19, 2014.

SUBMITTER: Xiao S

PROVIDER: S-EPMC7967962 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

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.

Xiao Shifu S Chan Piu P Wang Tao T Hong Zhen Z Wang Shuzhen S Kuang Weihong W He Jincai J Pan Xiaoping X Zhou Yuying Y Ji Yong Y Wang Luning L Cheng Yan Y Peng Ying Y Ye Qinyong Q Wang Xiaoping X Wu Yuncheng Y Qu Qiumin Q Chen Shengdi S Li Shuhua S Chen Wei W Xu Jun J Peng Dantao D Zhao Zhongxin Z Li Yansheng Y Zhang Junjian J Du Yifeng Y Chen Weixian W Fan Dongsheng D Yan Yong Y Liu Xiaowei X Zhang Wei W Luo Benyan B Wu Wenyuan W Shen Lu L Liu Chunfeng C Mao Peixian P Wang Qiumei Q Zhao Qianhua Q Guo Qihao Q Zhou Yongtao Y Li Yi Y Jiang Lijun L Ren Wenwei W Ouyang Yingjun Y Wang Yan Y Liu Shuai S Jia Jianjun J Zhang Nan N Liu Zhonglin Z He Raoli R Feng Tingyi T Lu Wenhui W Tang Huidong H Gao Ping P Zhang Yingchun Y Chen Lanlan L Wang Lei L Yin You Y Xu Qun Q Xiao Jinsong J Cong Lin L Cheng Xi X Zhang Hui H Gao Dan D Xia Minghua M Lian Tenghong T Peng Guoping G Zhang Xu X Jiao Bin B Hu Hua H Chen Xueyan X Guan Yihui Y Cui Ruixue R Huang Qiu Q Xin Xianliang X Chen Hongjian H Ding Yu Y Zhang Jing J Feng Teng T Cantillon Marc M Chen Kewei K Cummings Jeffrey L JL Ding Jian J Geng Meiyu M Zhang Zhenxin Z

Alzheimer's research & therapy 20210317 1

<h4>Background</h4>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.<h4>Methods</h4>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 pri ...[more]

PMID: 33731209

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Dataset Information

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.

Background

Methods

Results

Conclusions

Trial registration

Publications

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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