Clinical Trial

Long-term Efficacy and Safety Study of GV-971

Active, Not Recruiting Phase 4
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Record status
This record was last updated November 15, 2024 (before its estimated January 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-01-03; most recent amendment 2024-11-13.
Status change: Recruiting → Active, Not Recruiting 2023-05-25
Trial Details
NCT Number NCT05181475
Lead Sponsor Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Conditions Alzheimer Disease
Enrollment 800 participants
Start Date 2021-12-07
Primary Completion 2025-01 (estimated)
Study Completion 2025-06 (estimated)
Updated on ClinicalTrials.gov 2024-11-15