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NCT05181475Active, not recruitingPhase 4

Long-term Efficacy and Safety Study of GV-971

A Clinical Study to Evaluate the Long-term Efficacy and Safety of Sodium Oligomannate Capsules (GV-971)

Source: ClinicalTrials.gov · Last updated 15 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
800 (actual)
First submitted
2 Dec 2021
Start date
7 Dec 2021
Primary completion date
Jan 2025
Lead sponsor
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
NCT number
NCT05181475

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 800
  • From 7 Dec 2021 to the primary completion date, Jan 2025
  • 40 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have received GV-971 treatment within 6 months prior to screening;

Other illness

  • Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.

Lab values

  • Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;

Other

  • Female participants who are pregnant or lactating;
  • Patients who cannot cooperate to complete the follow-up inquiries;

Who the study is looking for

  • Aged 50 to 85 years (inclusive), with no restriction on gender;
  • Patients who met criteria for "probable AD" by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria;
  • Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive;
  • 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;
  • Patients receiving GV-971 treatment prescribed by clinicians;
  • Sign the informed consent form.

Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
No.6 HeBei Provincial People's Hospital
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BaodingChinaUnknown status
Beijing Chao-Yang Hospital
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Peking University Shougang Hospital
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BeijingChinaUnknown status
The First Hospital of Changsha
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ChangshaChinaUnknown status
West China School of Medicine/West China Hospital of Sichuan University
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ChengduChinaUnknown status
The Second Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
Affiliated Zhongshan Hospital of Dalian University
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DalianChinaUnknown status
The Second Hospital of Dalian Medical University
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DalianChinaUnknown status
The First People's Hospital of Foshan
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FoshanChinaUnknown status
The Affiliated Brain Hospital of Guangzhou Medical University
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GuangzhouChinaUnknown status
Nanfang Hospital
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GuangzhouChinaUnknown status
The Affiliated Hospital of Guizhou Medical University
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GuiyangChinaUnknown status
The Second Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The Affiliated Hospital of Hangzhou Normal University
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HangzhouChinaUnknown status
Tongde Hospital of Zhejiang Province
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HangzhouChinaUnknown status
Zhejiang Hospital
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HangzhouChinaUnknown status
Central Hospital Affiliated to Shandong First Medical University
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JinanChinaUnknown status
The Second Hospital of Shandong University
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JinanChinaUnknown status
The First Hospital of Lanzhou University
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LanzhouChinaUnknown status
Lanzhou University Second Hospital
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LanzhouChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University
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NanjingChinaUnknown status
The Affiliated Hospital of Qingdao University
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QingdaoChinaUnknown status
Shanghai Mental Health Center
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ShanghaiChinaUnknown status
Shanghai 6th People's Hospital
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ShanghaiChinaUnknown status
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
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ShanghaiChinaUnknown status
Shanghai East Hospital
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ShanghaiChinaUnknown status
Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine
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ShanghaiChinaUnknown status
Zhongshan Hospital
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ShanghaiChinaUnknown status
Peking University Shenzhen Hospital
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ShenzhenChinaUnknown status
Shenzhen People's Hospital
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ShenzhenChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Zhongnan Hospital of Wuhan University
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WuhanChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Wuxi Mental Health Center
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WuxiChinaUnknown status
Wuxi No.2 People's Hospital
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WuxiChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaUnknown status
Northern Jiangsu People's Hospital
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YangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.