An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
NCT ID: NCT05908695
Last Updated: 2023-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
1312 participants
INTERVENTIONAL
2023-08-31
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Efficacy and Safety Study of Sodium Oligo-mannurarate (GV-971) Capsule for the Treatment of Alzheimer's Disease
NCT02293915
A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease
NCT04520412
Long-term Efficacy and Safety Study of GV-971
NCT05181475
A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules (GV-971)
NCT05058040
Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease
NCT05430867
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GV-971
GV-971
Administered PO
Placebo
Placebo
Administered PO
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GV-971
Administered PO
Placebo
Administered PO
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* History of cognitive and functional decline over at least 1 year.
* MMSE scores between 11 and 24 (inclusive) at baseline.
* Hachinski Ischemic Score (HIS) scale total score ≤ 4.
* Hamilton Rating Scale for Depression/17 items (HAMD) total score ≤ 10.
* Brain MRI scan show the highest possibility of AD.
* Have a reliable study partner/caregiver.
* Sign the informed consent form.
Exclusion Criteria
* Major structural brain disease as judged by MRI.
* A resting heart rate of \< 50 beats per minute (bpm) after 10 minutes of rest.
* Major medical illness or unstable medical condition within 12 months of screening.
* Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline.
* Inadequate hepatic function.
* Inadequate organ function.
* ECG clinically significant abnormalities.
50 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Huainan First People's Hospital
Huainan, Anhui, China
Beijing Anding Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
The First Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hopsital of Xiamen University
Xiamen, Fujian, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hopsital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Second Affiliated Hopsital of Guangzhou Medical University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The First People's Hospital of Nanning
Nanning, Guangxi, China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Hopsital of Hebei Medical University
Shijiazhuang, Hebei, China
Tangshan Workers' Hospital
Tangshan, Hebei, China
The First Affiliated Hopsital of Nanyang Medical College
Nanyang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Chenzhou First People's Hospital
Chenzhou, Hunan, China
Yueyang Central Hospital
Yueyang, Hunan, China
Huai'an Second People's Hospital
Huai'an, Jiangsu, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Yangzhou First People's Hospital
Yangzhou, Jiangsu, China
Jiujiang University Affiliated Hospital
Jiujiang, Jiangxi, China
The Second Affiliated Hopsital of Nanchang University
Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Inner Mongolia International Hospital of Mongolian Medicine
Hohhot, Neimenggu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Xianyang Hospital of Yan'an University
Xianyang, Shanxi, China
The Second Affiliated Hospital of Air Force Medical University （Tangdu Hospital of Air Force Medical University）
Xi’an, Shanxi, China
Xi'an Mental Health Center
Xi’an, Shanxi, China
Hospital of Chengdu University of TCM
Chengdu, Sichuan, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
The Affiliated Hopsital of Inner Mongolia Medical University
Ürümqi, Xinjiang, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Second Hospital of Jiaxing
Jiaxing, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Mei Zhang
Role: primary
Chuanqing Yu
Role: backup
Qinge Zhang
Role: primary
Guangzhi Liu
Role: primary
Haibo Chen
Role: primary
Jiawei Wang
Role: primary
Shudong Qiao
Role: primary
Shengyuan Yu
Role: primary
Jianping Jia
Role: primary
Kunmu Zheng
Role: primary
Yefeng Cai
Role: primary
Yuping Ning
Role: primary
Qin Liu
Role: primary
Jun Liu
Role: primary
Xuhui Chen
Role: primary
Xianfeng Li
Role: primary
Huiying Zhao
Role: primary
Qinying Ma
Role: primary
Yaling Liu
Role: primary
Yongqiu Li
Role: primary
Qian Deng
Role: primary
Jiewen Zhang
Role: primary
Wei Shao
Role: primary
Deren Hou
Role: primary
Lu Shen
Role: primary
Xiaoxi Yao
Role: primary
Xiang Huang
Role: primary
Liandong Zhao
Role: primary
Rong Lu
Role: primary
Maohong Cao
Role: primary
Guiyun Cui
Role: primary
Tieyu Tang
Role: primary
Xiangbin Wu
Role: primary
Zhenyu Tang
Role: primary
Li Sun
Role: primary
Qile Temu
Role: primary
Yi Li
Role: primary
Yifeng Du
Role: primary
Chuanzhu Yan
Role: primary
Yanping Sun
Role: primary
Zhigang Liang
Role: primary
Jianren Liu
Role: primary
Aihong Guo
Role: primary
Wei Zhang
Role: primary
Wei Dang
Role: primary
Dongdong Yang
Role: primary
Meiyun Zhang
Role: primary
Chunyang Li
Role: primary
Xiufeng Xu
Role: primary
Guoping Peng
Role: primary
Yanping Wang
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GV-971-PoCT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.