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

Paused · Phase 3 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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

Key facts

Study ID

NCT04520412

Run by

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

People needed

2046

Starts

2020-10-27

Expected to finish

2026-10-01

Last updated by the study team

2022-11-23

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Banner Sun Health Research Institute — Sun City, Arizona, United States
• Banner Alzheimer's Institute — Tucson, Arizona, United States
• Irvine Clinical Research — Irvine, California, United States
• Sunwise Clinical Research — Lafayette, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Pacific Research Network, Inc — San Diego, California, United States
• Pacific Research Network — San Diego, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• Schuster Med Research Institute — Sherman Oaks, California, United States
• JEM Research LLC — Atlantis, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Finlay Medical Research Corp — Greenacres City, Florida, United States
• Velocity Clinical Research — Hallandale, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Charter Research, LLC — Lady Lake, Florida, United States
• Innovative Clinical Research, Inc. — Lauderhill, Florida, United States
• ClinCloud, LLC — Maitland, Florida, United States
• Merritt Island Medical Research, LLC — Merritt Island, Florida, United States
• Collier Neurologic Specialists — Naples, Florida, United States
• Suncoast Clinical Research Inc. — New Port Richey, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Synexus Clinical Research — Orlando, Florida, United States
• Cognitive Clinical Trials, LLC — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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