drugset / Trial / NCT05181475

Long-term Efficacy and Safety Study of GV-971

NCT05181475 ↗

Phase 4 Active not recruiting 800 enrolled Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-12-07
Primary completion
2025-01
Completion
2025-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Oligomannate Oligonucleotide (other) 450 mg Oral

Indications