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
文献类型：期刊论文
| 作者 | Xiao,Shifu1,2; Chan,Piu3; Wang,Tao1,2; Hong,Zhen4; Wang,Shuzhen5; Kuang,Weihong6; He,Jincai7; Pan,Xiaoping8; Zhou,Yuying9; Ji,Yong9 |
| 刊名 | Alzheimer's Research & Therapy
 |
| 出版日期 | 2021-03-17 |
| 卷号 | 13期号:1 |
| 关键词 | Sodium oligomannate Efficacy Safety Alzheimer’s disease Clinical trial |
| DOI | 10.1186/s13195-021-00795-7 |
| 通讯作者 | Xiao,Shifu(xiaoshifu@msn.com) ; Geng,Meiyu(mygeng@simm.ac.cn) ; Zhang,Zhenxin(wuzhangzhenxin@163.com) |
| 英文摘要 | AbstractBackgroundNew 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.MethodsWe 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.ResultsA 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? |
| 语种 | 英语 |
| 出版者 | BioMed Central |
| WOS记录号 | BMC:10.1186/S13195-021-00795-7 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/295174]  |
| 专题 | 新药研究国家重点实验室 |
| 通讯作者 | Xiao,Shifu; Geng,Meiyu; Zhang,Zhenxin |
| 作者单位 | 1.Shanghai Jiaotong University School of Medicine; Department of Geriatric Psychiatry, Shanghai Mental Health Center 2.Shanghai Jiaotong University; Alzheimer’s Disease and Related Disorders Center 3.Xuanwu Hospital Capital Medical University 4.Fudan University; Huashan Hospital 5.Qilu Hospital of Shandong University 6.West China Hospital of Sichuan University 7.The First Affiliated Hospital of Wenzhou Medical University 8.South China University of Technology; Guangzhou First People’s Hospital, School of Medicine 9.Huanhu Hospital Affiliated to Nankai University; Tianjin Huanhu Hospital 10.Department of Geriatric Neurology of PLA General Hospital |
| 推荐引用方式 GB/T 7714 | Xiao,Shifu,Chan,Piu,Wang,Tao,et al. 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[J]. Alzheimer's Research & Therapy,2021,13(1). |
| APA | Xiao,Shifu.,Chan,Piu.,Wang,Tao.,Hong,Zhen.,Wang,Shuzhen.,...&Zhang,Zhenxin.(2021).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.Alzheimer's Research & Therapy,13(1). |
| MLA | Xiao,Shifu,et al."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".Alzheimer's Research & Therapy 13.1(2021). |
入库方式： OAI收割
来源：上海药物研究所
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