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.
- Diseases
- Alzheimer disease
- 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
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| No.6 HeBei Provincial People's Hospital Coordinator of this site? Confirm its status | Baoding | China | Unknown status |
| Beijing Chao-Yang Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Shougang Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Changsha Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China School of Medicine/West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Affiliated Zhongshan Hospital of Dalian University Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| The Second Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| The First People's Hospital of Foshan Coordinator of this site? Confirm its status | Foshan | China | Unknown status |
| The Affiliated Brain Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| The Second Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Affiliated Hospital of Hangzhou Normal University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Tongde Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Central Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Second Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First Hospital of Lanzhou University Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| Lanzhou University Second Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shanghai Mental Health Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai 6th People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Tongren Hospital Shanghai Jiao Tong University School Of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Peking University Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuxi Mental Health Center Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Wuxi No.2 People's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Northern Jiangsu People's Hospital Coordinator of this site? Confirm its status | Yangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.