Evidence map›Paper›PMID 32928279›Full record

Trial reportAlzheimer's research & therapy2020

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

Tao Wang, Weihong Kuang, Wei Chen, Wenwei Xu, Liming Zhang, Yingjie Li, Hailin Li, Ying Peng, Yangmei Chen, Baojun Wang and 21 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Alzheimer's research & therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01453569 (Phase II Study of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer Disease), which is not on this map. Cited by 45 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 1 pooled it
7.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01453569 phase2completednot on this map

Phase II Study of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer Disease

TypeinterventionalSponsorShanghai Greenvalley Pharmaceutical Co., Ltd.Ran2011 to 2013Enrolled255ConditionsAlzheimer Disease, Cognitive ImpairmentArmsSodium oligo-mannurarate 600mg, Sodium oligo-mannurarate 900mg, Placebo
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 1 synthesis or guideline pooled it, 89 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors at 20 institutions in 1 country.

Tao WangDepartment of Geriatric Psychiatry, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai, China. wtshhwy@163.com.
Weihong KuangDepartment of Psychiatry, West China Hospital of Sichuan University, Chengdu, Sichuan, China.
Wei ChenDepartment of Neurology, Sir Run Run Shaw Hospital, Affiliated with the Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Wenwei XuDepartment of Geriatric Psychiatry, Wuxi Mental Health Center, Wuxi, Jiangsu, China.
Liming ZhangDepartment of Neurology, First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.
Yingjie LiDepartment of Neurology, The Hospital of 81st Group Army PLA, Zhangjiakou, Hebei, China.
Hailin LiDepartment of Geriatric Psychiatry, Nanjing Brain Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu, China.
Ying PengDepartment of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.
Yangmei ChenDepartment of Neurology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Baojun WangDepartment of Neurology, Baotou Central Hospital, Baotou, Inner Mongolia Autonomous Region, China.
Jinsong XiaoDepartment of Neurology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.
Honghua LiDepartment of Neurology, Central War Zone General Hospital of the Chinese People's Liberation Army, Wuhan, Hubei, China.
Chuanzhu YanDepartment of Neurology, Qilu Hospital of Shandong University, Jinan, Shandong, China.
Yifeng DuDepartment of Neurology, Shandong Provincial Hospital, Jinan, Shandong, China.
Mouni TangDepartment of Geriatric Psychiatry, Guangzhou Brian Hospital, Guangzhou, Guangdong, China.
Zhiyi HeDepartment of Neurology, The First Hospital of China Medical University, Shenyang, Liaoning, China.
Haibo ChenDepartment of Neurology, Beijing Hospital, Beijing, China.
Wei LiDepartment of Neurology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Hong LinDepartment of Neurology, Tangdu Hospital, Air Force Military Medical University, Xi'an, Shanxi, China.
Shugui ShiDepartment of Neurology, The First Hospital Affiliated to AMU (Southwest Hospital), Chongqing, China.
Jianzhong BiDepartment of Neurology, The Second Hospital of Shandong University, Jinan, Shandong, China.
Huadong ZhouDepartment of Neurology, Daping Hospital, Chongqing, China.
Yan ChengDepartment of Neurology, Tianjin Medical University general hospital, Tianjin, China.
Xiaoping GaoDepartment of Neurology, Hunan Provincial People's Hospital, Changsha, Hunan, China.
Yihui GuanPET Center Huashan Hospital Fudan University, Shanghai, China.
Qiu HuangMed-X Research Institution, Shanghai Jiao Tong University, Shanghai, China.
Kewei ChenBanner Alzheimer's Institute, Phoenix, AZ, USA.
Xianliang XinShanghai Green Valley Pharmaceutical Co Ltd, Shanghai, China.
Jian DingState Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 555 Zu Chong Zhi Road, Shanghai, 201203, China.
Meiyu GengState Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 555 Zu Chong Zhi Road, Shanghai, 201203, China. mygeng@simm.ac.cn.
Shifu XiaoDepartment of Geriatric Psychiatry, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai, China. xiaoshifu@msn.com.ORCID 0000-0002-4721-9646
Shanghai Jiao Tong University · CNChinese Academy of Sciences · CNNanjing Brain Hospital · CNBanner Alzheimer’s InstituteBaotou Central Hospital · CNBeijing Hospital · CNDalian Medical University · CNDaping Hospital · CNFirst Hospital of China Medical University · CNFudan University · CNGuangzhou Psychiatric Hospital · CNHarbin Medical University · CNHunan Provincial People's Hospital · CNJiangxi Mental Health Center · CNQilu Hospital of Shandong University · CNSecond Hospital of Shandong University · CNShandong Provincial Hospital · CNShanghai Botanical Garden · CNSichuan University · CNSir Run Run Shaw Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSodium 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 < 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 uncorrected p = 0.05. The respective rates of treatment-related AEs were 5.9%, 14.3%, and 3.5%.

conclusionsGV-971 was safe and well tolerated. GV-971 900 mg was chosen for phase III clinical study.

trial registrationClinicalTrials.gov, NCT01453569 . Registered on October 18, 2011.

Indexed as

Alzheimer DiseaseChinaCholinesterase InhibitorsDouble-Blind MethodHumansMannoseOligosaccharidesSodiumTreatment OutcomeCholinesterase InhibitorsGV-971MannoseOligosaccharidesSodiumAlzheimer’s diseaseClinical trialEfficacySafetySodium oligomannate

Identifiers

PMID32928279
PMCPMC7489025
OpenAlexW3085133919

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.