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

Green Valley Pharmaceuticals

Status and phase: Suspended; Phase 3

Conditions: Alzheimer Disease

Treatments: Drug: GV-971; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04520412

GV971-007

Details and patient eligibility

About

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

Enrollment: 2,046 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,046 participants in 2 patient groups, including a placebo group

GV-971

Experimental group

Treatment:

Drug: GV-971

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo