Status:
SUSPENDED
A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in mild to moderate Alzheimer's disease.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
2046 Patients enrolled
Trial Details
Trial ID
NCT04520412
Start Date
October 27 2020
End Date
October 1 2026
Last Update
November 23 2022
Active Locations (171)
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1
Cognitive Clinical Trials, LLC
Gilbert, Arizona, United States, 85297
2
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
3
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
4
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351