Clinical Trials in China / NCT05058040
Active, not recruiting
Phase 4
A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules (GV-971)
NCT05058040 · tracked via the Priya Life Science China tracker
Condition(s) studied
Alzheimer Disease
Investigational drug(s) / intervention(s)
Sodium Oligomannate Capsules: 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.
Study summary
A clinical study to evaluate the long-term safety of Sodium Oligomannate Capsules (GV-971)
Eligibility
Inclusion Criteria:
* Subjects eligible for this study must meet all of the following criteria:
1. ≥18 years of age;
2. Signed informed consent form;
3. Patients receiving GV-971 treatment prescribed by clinicians;
Exclusion Criteria:
* A subject may be excluded from participation in the study if any of the following apply:
1. Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;
2. Female participants who are pregnant or lactating;
3. Patients who cannot cooperate to complete the follow-up inquiries;
4. Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.
Primary outcome measure(s)
- Long-term safety of GV-971 in clinical practice during 48 weeks — Week 48
The incidence of adverse reactions and AE/SAE in patients treated with GV-971 during the 48-week monitoring period - Long-term safety of GV-971 in clinical practice during 96 weeks — Week 96
The incidence of adverse reactions and AE/SAE in patients treated with GV-971 during the 96-week monitoring period
Trial sites (63)
| Facility | City | Region | Status |
|---|---|---|---|
| Anhui Mental Health Center | Hefei | Anhui | |
| The First Affiliated Hospital of USTC(Anhui Provincial Hospital) | Hefei | Anhui | |
| Beijing Bo'ai Hospital | Beijing | Beijing Municipality | |
| Beijing Geriatric Hospital | Beijing | Beijing Municipality | |
| Beijing Luhe Hospital, Capital Medical University | Beijing | Beijing Municipality | |
| Dongfang Hospital Beijing University of Chinese Medicine | Beijing | Beijing Municipality | |
| Sanbo Brain Hospital Capital Medical University | Beijing | Beijing Municipality | |
| Chongqing 11th People's Hospital (Chongqing Special Care Hospital) | Chongqing | Chongqing Municipality | |
| Xiamen Xianyue Hospital | Xianmencun | Fujian | |
| Dongguan People's Hospital | Dongguan | Guangdong | |
| Red Cross Hospital of Guangzhou | Guangzhou | Guangdong | |
| The Third Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | |
| Zhujiang Hospital, Southern Medical University | Guangzhou | Guangdong | |
| Shenzhen Luohu District People's Hospital | Shenzhen | Guangdong | |
| Shenzhen Second People's Hospital (The First Affiliated Hospital of Shenzhen University) | Shenzhen | Guangdong | |
| Zhuhai People's Hospital | Zhuhai | Guangdong | |
| Guihang Guiyang Hospital | Guiyang | Guizhou | |
| Second People's Hospital of Guizhou Province | Guiyang | Guizhou | |
| The First Affiliated Hospital of Guizhou University of Chinese Medicine | Guiyang | Guizhou | |
| The Second Affiliated Hospital of Guizhou University of Chinese Medicine | Guiyang | Guizhou | |
| Hebei Petro China Central Hospital | Langfang | Hebei | |
| General Hospital of North China Petroleum Administration (North China Hospital Affiliated to University of Chinese Academy of Sciences) | Renqiu | Hebei | |
| Wuhan Central Hospital | Wuhan | Hubei | |
| Wuhan Mental Health Center | Wuhan | Hubei | |
| Lianyungang Chinese Medicine Hospital | Lianyungang | Jiangsu | |
| The First People's Hospital of Lianyungang | Lianyungang | Jiangsu | |
| Nanjing First Hospital | Nanjing | Jiangsu | |
| Nantong No.1 People's Hospital | Nantong | Jiangsu | |
| Changshu No.2 People's Hospital | Suzhou | Jiangsu | |
| Suzhou Guangji Hospital | Suzhou | Jiangsu | |
| Suzhou Municipal Hospital(Geriatrics) | Suzhou | Jiangsu | |
| Suzhou Municipal Hospital | Suzhou | Jiangsu | |
| Suzhou Ninth People's Hospital | Suzhou | Jiangsu | |
| Taizhou Second People's Hospital | Taizhou | Jiangsu | |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | |
| Zhenjiang mental health center | Zhenjiang | Jiangsu | |
| Jinan Central Hospital Affiliated To Shandong University | Jinan | Shandong | |
| Shandong Mental Health Center | Jinan | Shandong | |
| Affiliated Hospital of Jining Medical University | Jining | Shandong | |
| Liaocheng People's Hospital | Liaocheng | Shandong |
+ 23 more sites — see the full list on the official registry below.
More Green Valley (Shanghai) Pharmaceuticals Co., Ltd. trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05058040 on ClinicalTrials.gov ↗ ← All trials in China