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

Phase 3
Waitlist Available
Research Sponsored by Shanghai Greenvalley Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks, 24 weeks, 52 weeks
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new drug called GV-971 to see if it is safe and effective for people with mild to moderate Alzheimer's disease. The drug aims to help by reducing inflammation in the brain and clearing out harmful proteins. Researchers hope this will slow down the progression of Alzheimer's symptoms.

Eligible Conditions
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks, 24 weeks, 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks, 24 weeks, 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in the ADAS-cog/11 score
Change from baseline in the ADCS-CGIC score
Secondary study objectives
Assess the efficacy of GV-971 throughout the OLE period
Change from baseline in ADCS-ADL23 score
Change from baseline in MMSE score
+3 more
Other study objectives
Evaluate the effect of GV-971 on brain structure neurodegeneration
Evaluate the population PK

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GV-971Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GV-971
2016
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Shanghai Greenvalley Pharmaceutical Co., Ltd.Lead Sponsor
7 Previous Clinical Trials
34,291 Total Patients Enrolled
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.Lead Sponsor
3 Previous Clinical Trials
4,612 Total Patients Enrolled
Study Director, Ph DStudy DirectorGreen Valley (Shanghai) Pharmaceuticals Co., Ltd.
~369 spots leftby Dec 2025
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