NCT05908695RecruitingPhase 4
An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
A 36-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 9 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The primary purpose of this study is to confirm the clinical efficacy and mechanism of action of GV-971, and identify incidence of known adverse reactions in long-term use and observe new adverse reactions, providing more guidance for clinical use.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1312 (estimated)
- First submitted
- 31 May 2023
- Start date
- 31 Aug 2023
- Primary completion date
- Jun 2029
- Lead sponsor
- Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
- Diseases
- Alzheimer disease
- NCT number
- NCT05908695
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1312
- From 31 Aug 2023 to the primary completion date, Jun 2029
- 50 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
- Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline.
Other illness
- Diagnosis of a dementia-related central nervous system disease other than AD.
- 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.
Other
- Inadequate hepatic function.
- Inadequate organ function.
- ECG clinically significant abnormalities.
Who the study is looking for
- Mild to moderate AD per NIA-AA.
- 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.
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anding Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Anzhen Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Beijing Tongren Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Peking University Shougang Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| The First Medical Center, Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| The First Bethune Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Hospital of Chengdu University of TCM Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| Chenzhou First People's Hospital Coordinator of this site? Confirm its status | Chenzhou | China | Not yet recruiting |
| The Second Affiliated Hopsital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangdong Provincial Hospital of Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The First Affiliated Hopsital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The Affiliated Brain Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| Inner Mongolia International Hospital of Mongolian Medicine Coordinator of this site? Confirm its status | Hohhot | China | Not yet recruiting |
| Huai'an Second People's Hospital Coordinator of this site? Confirm its status | Huai'an | China | Not yet recruiting |
| Huainan First People's Hospital Coordinator of this site? Confirm its status | Huainan | China | Recruiting |
| The Second Hospital of Jiaxing Coordinator of this site? Confirm its status | Jiaxing | China | Recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| Jiujiang University Affiliated Hospital Coordinator of this site? Confirm its status | Jiujiang | China | Recruiting |
| First Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Not yet recruiting |
| The Second Affiliated Hopsital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Nanjing Brain Hospital Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| The First People's Hospital of Nanning Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Not yet recruiting |
| The First Affiliated Hopsital of Nanyang Medical College Coordinator of this site? Confirm its status | Nanyang | China | Not yet recruiting |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Not yet recruiting |
| Qilu Hospital of Shandong University (Qingdao) Coordinator of this site? Confirm its status | Qingdao | China | Not yet recruiting |
| Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Peking University Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Not yet recruiting |
| The First Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Shijiazhuang People's Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| The Second Hopsital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Not yet recruiting |
| Tangshan Workers' Hospital Coordinator of this site? Confirm its status | Tangshan | China | Recruiting |
| Tianjin People's Hospital Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| The Affiliated Hopsital of Inner Mongolia Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Not yet recruiting |
| Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital) Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| The First Affiliated Hopsital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Not yet recruiting |
| Xi'an Mental Health Center Coordinator of this site? Confirm its status | Xi’an | China | Not yet recruiting |
| The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital of Air Force Medical University) Coordinator of this site? Confirm its status | Xi’an | China | Not yet recruiting |
| Xianyang Hospital of Yan'an University Coordinator of this site? Confirm its status | Xianyang | China | Not yet recruiting |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
| Yangzhou First People's Hospital Coordinator of this site? Confirm its status | Yangzhou | China | Not yet recruiting |
| Yantai Yuhuangding Hospital Coordinator of this site? Confirm its status | Yantai | China | Not yet recruiting |
| Yueyang Central Hospital Coordinator of this site? Confirm its status | Yueyang | China | Not yet recruiting |
| Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.