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Your search keyword '"Marc Cantillon"' showing total 2 results
Start Over Author "Marc Cantillon" Journal alzheimer's research & therapy
2 results on '"Marc Cantillon"'

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

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

Subjects
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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2. 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

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

Subjects
medicine.medical_specialty, China, Neurology, Efficacy, Cognitive Neuroscience, Phases of clinical research, Oligosaccharides, Placebo, lcsh:RC346-429, lcsh:RC321-571, Double-Blind Method, Alzheimer Disease, Internal medicine, Activities of Daily Living, medicine, Humans, Adverse effect, lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry, lcsh:Neurology. Diseases of the nervous system, business.industry, Incidence (epidemiology), Research, Sodium, Sodium oligomannate, Confidence interval, Clinical trial, Treatment Outcome, Tolerability, Pharmaceutical Preparations, Neurology (clinical), Cholinesterase Inhibitors, Safety, business, Alzheimer’s disease, Mannose
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 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, NCT02293915. Registered on November 19, 2014

Published
2021

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