A phase II randomized trial of sodium oligomannate in Alzheimer’s dementia
文献类型：期刊论文
| 作者 | Wang,Tao1,2; Kuang,Weihong3; Chen,Wei4; Xu,Wenwei5; Zhang,Liming6; Li,Yingjie7; Li,Hailin8; Peng,Ying9; Chen,Yangmei10; Wang,Baojun11 |
| 刊名 | Alzheimer's Research & Therapy
 |
| 出版日期 | 2020-09-14 |
| 卷号 | 12期号:1 |
| 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 | AbstractBackgroundSodium oligomannate (GV-971), a marine-derived oligosaccharide, is a novel agent that may improve cognition in AD patients.MethodsThe 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.ResultsComparing 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? |
| 语种 | 英语 |
| 出版者 | BioMed Central |
| WOS记录号 | BMC:10.1186/S13195-020-00678-3 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/291604]  |
| 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.Shanghai Jiaotong University School of Medicine; Department of Geriatric Psychiatry, Shanghai Mental Health Center 2.Alzheimer’s Disease and Related Disorders Center of Shanghai Jiaotong University 3.West China Hospital of Sichuan University; Department of Psychiatry 4.Sir Run Run Shaw Hospital, Affiliated with the Zhejiang University School of Medicine; Department of Neurology 5.Wuxi Mental Health Center; Department of Geriatric Psychiatry 6.First Affiliated Hospital of Harbin Medical University; Department of Neurology 7.The Hospital of 81st Group Army PLA; Department of Neurology 8.Nanjing Brain Hospital Affiliated to Nanjing Medical University; Department of Geriatric Psychiatry 9.Sun Yat-Sen University; Department of Neurology, Sun Yat-Sen Memorial Hospital 10.The Second Affiliated Hospital of Chongqing Medical University; Department of Neurology |
| 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]. Alzheimer's Research & Therapy,2020,12(1). |
| 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.Alzheimer's Research & Therapy,12(1). |
| MLA | Wang,Tao,et al."A phase II randomized trial of sodium oligomannate in Alzheimer’s dementia".Alzheimer's Research & Therapy 12.1(2020). |
入库方式： OAI收割
来源：上海药物研究所
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