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
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ACTIVE_NOT_RECRUITING
PHASE4
800 participants
INTERVENTIONAL
2021-12-07
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sodium Oligomannate Capsules (GV-971)
The recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Patients who met criteria for "probable AD" by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria;
3. Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive;
4. Patients who have received at least primary education and have capacity to complete the measurement of cognition and other tests as specified in the protocol;
5. Patients receiving GV-971 treatment prescribed by clinicians;
6. Sign the informed consent form.
Exclusion Criteria
2. Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;
3. Female participants who are pregnant or lactating;
4. Patients who cannot cooperate to complete the follow-up inquiries;
5. Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.
50 Years
85 Years
ALL
No
Sponsors
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Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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GV-971-PMS-B
Identifier Type: -
Identifier Source: org_study_id
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