A phase II randomized trial of sodium oligomannate in Alzheimer's dementia

doi:10.1186/s13195-020-00678-3

	A phase II randomized trial of sodium oligomannate in Alzheimer's dementia
	Wang, Tao 8,9; Kuang, Weihong 10; Chen, Wei 11; Xu, Wenwei 12; Zhang, Liming 13; Li, Yingjie 14; Li, Hailin 15; Peng, Ying 16; Chen, Yangmei 17; Wang, Baojun 18
刊名	ALZHEIMERS RESEARCH & THERAPY
	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.
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关键词	OLIGOSACCHARIDE SUGAR CHAIN ; MINI-MENTAL STATE ; NEUROPSYCHIATRIC INVENTORY ; ACIDIC OLIGOSACCHARIDE ; PLACEBO-RESPONSE ; CHINESE VERSION ; CLINICAL-TRIALS ; RATING-SCALE ; DISEASE ; EFFICACY
WOS研究方向	Neurosciences & Neurology
语种	英语
出版者	BMC
WOS记录号	WOS:000571918100002
内容类型	期刊论文
源URL	[http://119.78.100.183/handle/2S10ELR8/291244]
专题	中国科学院上海药物研究所
通讯作者	Wang, Tao; Geng, Meiyu; Xiao, Shifu
作者单位	1.Air Force Mil Med Univ, Dept Neurol, Tangdu Hosp, Xian, Shanxi, Peoples R China 2.AMU Southwest Hosp, Dept Neurol, First Hosp, Chongqing, Peoples R China 3.Shandong Univ, Dept Neurol, Second Hosp, Jinan, Shandong, Peoples R China 4.Daping Hosp, Dept Neurol, Chongqing, Peoples R China 5.Tianjin Med Univ Gen Hosp, Dept Neurol, Tianjin, Peoples R China 6.Hunan Prov Peoples Hosp, Dept Neurol, Changsha, Hunan, Peoples R China 7.Fudan Univ, PET Ctr, Huashan Hosp, Shanghai, Peoples R China 8.Shanghai Jiao Tong Univ, Dept Geriatr Psychiat, Shanghai Mental Hlth Ctr, Sch Med, Shanghai, Peoples R China 9.Shanghai Jiao Tong Univ, Alzheimers Dis & Related Disorders Ctr, 600 South Wan Ping Rd, Shanghai 200030, Peoples R China 10.Sichuan Univ, Dept Psychiat, West China Hosp, Chengdu, Sichuan, 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.