A 36-week randomized, double-blind study testing Sodium Oligomannate GV-971 safety and effectiveness for mild to moderate Alzheimers disease in adults aged 50 to 85

What this Trial Is About

Researchers are evaluating the clinical effects and safety of Sodium Oligomannate GV-971 for treating mild to moderate Alzheimers Disease. This Phase 4 study aims to confirm how GV-971 works, monitor known side effects over long-term use, and identify any new adverse reactions to provide improved clinical guidance. Participants are randomly assigned to receive either GV-971 or a placebo, both given by mouth. The study lasts 36 weeks and uses a double-blind design where neither participants nor researchers know which treatment is given, ensuring unbiased results. The trial involves multiple centers and compares the two groups in parallel. During the study, participants will undergo assessments of cognitive and functional abilities using tools like ADAS-cog12 and ADCS-ADL23 at the start and after 36 weeks. Additional measures include MMSE, CIBIC-Plus, and NPI scores. Safety is monitored throughout, and the study tracks any adverse events. The total participation time is about 36 weeks from baseline.

An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease