Trials / Active Not Recruiting
Active Not RecruitingNCT05181475
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)
- Status
- Active Not Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 800 (actual)
- Sponsor
- Green Valley (Shanghai) Pharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
Timeline
- Start date
- 2021-12-07
- Primary completion
- 2025-01-01
- Completion
- 2025-06-01
- First posted
- 2022-01-06
- Last updated
- 2024-11-15
Locations
40 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05181475. Inclusion in this directory is not an endorsement.