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Long-term Efficacy and Safety Study of GV-971
Sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Summary
Sodium Oligomannate Capsules (GV-971) has been approved for treatment of mild to moderate Alzheimer's disease and improving the cognitive function of patients. This study plans to observe, in the clinical patients, the long-term efficacy and safety of GV-971, as well as the changes in blood and gut microbiota biomarkers after treatment, to validate the mechanism of action of GV-971, in order to better guide the rational use of drug in clinical practice.
Official title: A Clinical Study to Evaluate the Long-term Efficacy and Safety of Sodium Oligomannate Capsules (GV-971)
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2021-12-07
Completion Date
2025-06
Last Updated
2024-11-15
Healthy Volunteers
No
Conditions
Interventions
Sodium Oligomannate Capsules (GV-971)
Sodium Oligomannate Capsules, each capsule contains 150 mg of sodium oligomannate. The recommended treatment is oral administration, 450 mg (3 capsules) per dose, bid, in morning and evening.
Locations (40)
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Nanfang Hospital
Guangzhou, Guangdong, China
The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
No.6 HeBei Provincial People's Hospital
Baoding, Hebei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The First Hospital of Changsha
Changsha, Hunan, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Wuxi Mental Health Center
Wuxi, Jiangsu, China
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
The Second Hospital of Shandong University
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine
Shanghai, Shanghai Municipality, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China