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

Launched by GREEN VALLEY (SHANGHAI) PHARMACEUTICALS CO., LTD. · Jun 8, 2023

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ClinConnect Summary

This clinical trial is studying a new treatment called Sodium Oligomannate (GV-971) for people with Alzheimer's disease. The main goal of the study is to see how well this treatment works over a long period of time and to understand how it affects patients. Researchers also want to identify any side effects that may occur with long-term use of the drug. The trial is currently looking for participants who are between 18 and 80 years old and who have mild to moderate Alzheimer's, meaning they've experienced some decline in memory and daily functioning for at least a year.

To be eligible for the study, participants should have a specific score on a cognitive test (MMSE) and must have a brain scan showing signs of Alzheimer's. It's important that they have a reliable caregiver who can support them throughout the trial. Participants will receive care and monitoring, and they will have regular check-ins to track their health and any potential side effects. If you're interested in learning more or think you might qualify, please reach out for more information about the study and how to get involved.

Gender

ALL

Eligibility 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.
• • Hachinski Ischemic Score (HIS) scale total score ≤ 4.
• • Hamilton Rating Scale for Depression/17 items (HAMD) total score ≤ 10.
• • Brain MRI scan show the highest possibility of AD.
• • Have a reliable study partner/caregiver.
• • Sign the informed consent form.
• 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 10 minutes of rest.
• • Major medical illness or unstable medical condition within 12 months of screening.
• • Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline.
• • Inadequate hepatic function.
• • Inadequate organ function.
• • ECG clinically significant abnormalities.