Clinical Trials in China / NCT05181475
Active, not recruiting
Phase 4
Long-term Efficacy and Safety Study of GV-971
NCT05181475 · tracked via the Priya Life Science China tracker
Condition(s) studied
Alzheimer Disease
Investigational drug(s) / intervention(s)
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.
Study summary
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.
Eligibility
Inclusion Criteria:
1. Aged 50 to 85 years (inclusive), with no restriction on gender;
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:
1. Patients who have received GV-971 treatment within 6 months prior to screening;
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.
Primary outcome measure(s)
- Change from baseline in the ADAS-cog/11 score — Baseline, 48 weeks
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.
Trial sites (40)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Chao-Yang Hospital | Beijing | Beijing Municipality | |
| Peking University Shougang Hospital | Beijing | Beijing Municipality | |
| Peking University Third Hospital | Beijing | Beijing Municipality | |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | |
| Lanzhou University Second Hospital | Lanzhou | Gansu | |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | |
| The First People's Hospital of Foshan | Foshan | Guangdong | |
| Nanfang Hospital | Guangzhou | Guangdong | |
| The Affiliated Brain Hospital of Guangzhou Medical University | Guangzhou | Guangdong | |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | |
| Shenzhen People's Hospital | Shenzhen | Guangdong | |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | |
| No.6 HeBei Provincial People's Hospital | Baoding | Hebei | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | |
| The First Hospital of Changsha | Changsha | Hunan | |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | |
| Wuxi Mental Health Center | Wuxi | Jiangsu | |
| Wuxi No.2 People's Hospital | Wuxi | Jiangsu | |
| Northern Jiangsu People's Hospital | Yangzhou | Jiangsu | |
| Affiliated Zhongshan Hospital of Dalian University | Dalian | Liaoning | |
| The Second Hospital of Dalian Medical University | Dalian | Liaoning | |
| Central Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | |
| The Second Hospital of Shandong University | Jinan | Shandong | |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | |
| Shanghai 6th People's Hospital | Shanghai | Shanghai Municipality | |
| Shanghai East Hospital | Shanghai | Shanghai Municipality | |
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | |
| Tongren Hospital Shanghai Jiao Tong University School Of Medicine | Shanghai | Shanghai Municipality | |
| Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine | Shanghai | Shanghai Municipality | |
| Zhongshan Hospital | Shanghai | Shanghai Municipality | |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | |
| West China School of Medicine/West China Hospital of Sichuan University | Chengdu | Sichuan | |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | |
| The Affiliated Hospital of Hangzhou Normal University | Hangzhou | Zhejiang | |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | |
| Tongde Hospital of Zhejiang Province | Hangzhou | Zhejiang | |
| Zhejiang Hospital | Hangzhou | Zhejiang | |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
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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 NCT05181475 on ClinicalTrials.gov ↗ ← All trials in China