A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease

• Status: Recruiting
• Trial end date: 2026-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in mild to moderate Alzheimer's disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Mild to moderate AD per NIA-AA.

• History of cognitive and functional decline over at least 1 year.

• MMSE scores between 11 and 24 (inclusive) at baseline.

• Brain MRI scan show the highest possibility of AD.

• Have a study partner/caregiver.

Exclusion Criteria:

• Diagnosis of a dementia-related central nervous system disease other than AD.

• Major structural brain disease as judged by MRI.

• A resting heart rate of < 50 beats per minute (bpm) after 5 minutes of rest in sitting or supine position.

• Major medical illness or unstable medical condition within 6 months of screening.

• Concomitant use of AChEIs and/or memantine within 30 days before first MMSE score, and during the study.

• Inadequate hepatic function.

• Inadequate organ and marrow function.

• ECG clinically significant abnormalities.