A phase II randomized trial of sodium oligomannate in Alzheimer's dementia
文献类型：期刊论文
| 作者 | Wang, Tao3,4; Kuang, Weihong5; Chen, Wei6; Xu, Wenwei2; Zhang, Liming7; Li, Yingjie8; Li, Hailin9; Peng, Ying10; Chen, Yangmei11; Wang, Baojun12 |
| 刊名 | ALZHEIMERS RESEARCH & THERAPY
 |
| 出版日期 | 2020-09-14 |
| 卷号 | 12期号:1页码:10 |
| 关键词 | Sodium oligomannate Efficacy Safety Alzheimer's disease Clinical trial |
| DOI | 10.1186/s13195-020-00678-3 |
| 通讯作者 | Wang, Tao(wtshhwy@163.com) ; Geng, Meiyu(mygeng@simm.ac.cn) ; Xiao, Shifu(xiaoshifu@msn.com) |
| 英文摘要 | Background: Sodium oligomannate (GV-971), a marine-derived oligosaccharide, is a novel agent that may improve cognition in AD patients. Methods: The 24-week multicenter, randomized, double-blind, placebo parallel controlled clinical trial was conducted in AD in China between 24 October 2011 and 10 July 2013. The study included a 4-week screening/washout period, followed by a 24-week treatment period. Patients were randomized in a 1:1:1 ratio to receive GV-971 900 mg, 600 mg, or placebo capsule in treatment period, respectively. The primary outcome was cognitive improvement as assessed by changes in Alzheimer's Disease Assessment Scale-cognitive subscale 12-item (ADAS-cog12) scores from baseline to week 24. The secondary efficacy outcomes included CIBIC-Plus, ADCS-ADL, and NPI at 24 weeks after treatment compared with baseline. A subgroup study was assessment of the change in cerebral glucose metabolism by fluorodeoxyglucose positron emission tomography measurements. Results: Comparing with the placebo group (n = 83, change - 1.45), the ADAS-cog12 score change in the GV-971 600-mg group (n = 76) was - 1.39 (p = 0.89) and the GV-971 900-mg group (n = 83) was - 2.58 (p = 0.30). The treatment responders according to CIBIC-Plus assessment were significantly higher in the GV-971 900-mg group than the placebo group (92.77% vs. 79.52%,p < 0.05). The GV-971 900-mg subgroup showed a lower decline of cerebral metabolic rate for glucose than the placebo subgroup at the left precuneus, right posterior cingulate, bilateral hippocampus, and bilateral inferior orbital frontal at uncorrectedp = 0.05. The respective rates of treatment-related AEs were 5.9%, 14.3%, and 3.5%. Conclusions: GV-971 was safe and well tolerated. GV-971 900 mg was chosen for phase III clinical study. |
| WOS关键词 | OLIGOSACCHARIDE SUGAR CHAIN ; MINI-MENTAL STATE ; NEUROPSYCHIATRIC INVENTORY ; ACIDIC OLIGOSACCHARIDE ; PLACEBO-RESPONSE ; CHINESE VERSION ; CLINICAL-TRIALS ; RATING-SCALE ; DISEASE ; EFFICACY |
| 资助项目 | Shanghai Green Valley Pharmaceutical Co., Ltd. ; National Major Scientific and Technological Special Project[2011ZX09101-003-01] ; National High Technology Research and Development Program of China[2006AA090501] |
| WOS研究方向 | Neurosciences & Neurology |
| 语种 | 英语 |
| WOS记录号 | WOS:000571918100002 |
| 出版者 | BMC |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/291244]  |
| 专题 | 新药研究国家重点实验室 |
| 通讯作者 | Wang, Tao; Geng, Meiyu; Xiao, Shifu |
| 作者单位 | 1.Banner Alzheimers Inst, Phoenix, AZ USA 2.Wuxi Mental Hlth Ctr, Dept Geriatr Psychiat, Wuxi, Jiangsu, Peoples R China 3.Shanghai Jiao Tong Univ, Dept Geriatr Psychiat, Shanghai Mental Hlth Ctr, Sch Med, Shanghai, Peoples R China 4.Shanghai Jiao Tong Univ, Alzheimers Dis & Related Disorders Ctr, 600 South Wan Ping Rd, Shanghai 200030, Peoples R China 5.Sichuan Univ, Dept Psychiat, West China Hosp, Chengdu, Sichuan, Peoples R China 6.Zhejiang Univ, Sir Run Run Shaw Hosp, Dept Neurol, Sch Med, Hangzhou, Zhejiang, Peoples R China 7.Harbin Med Univ, Dept Neurol, Affiliated Hosp 1, Harbin, Heilongjiang, Peoples R China 8.Hosp 81st Grp Army PLA, Dept Neurol, Zhangjiakou, Hebei, Peoples R China 9.Nanjing Med Univ, Dept Geriatr Psychiat, Nanjing Brain Hosp, Nanjing, Jiangsu, Peoples R China 10.Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Dept Neurol, Guangzhou, Guangdong, Peoples R China |
| 推荐引用方式 GB/T 7714 | Wang, Tao,Kuang, Weihong,Chen, Wei,et al. A phase II randomized trial of sodium oligomannate in Alzheimer's dementia[J]. ALZHEIMERS RESEARCH & THERAPY,2020,12(1):10. |
| APA | Wang, Tao.,Kuang, Weihong.,Chen, Wei.,Xu, Wenwei.,Zhang, Liming.,...&Xiao, Shifu.(2020).A phase II randomized trial of sodium oligomannate in Alzheimer's dementia.ALZHEIMERS RESEARCH & THERAPY,12(1),10. |
| MLA | Wang, Tao,et al."A phase II randomized trial of sodium oligomannate in Alzheimer's dementia".ALZHEIMERS RESEARCH & THERAPY 12.1(2020):10. |
入库方式： OAI收割
来源：上海药物研究所
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