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GREEN MEMORY

SuspendedPhase 3

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

A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory)

Asset

Sodium oligomannate

Listed sites

171

Recruiting sites

-

Enrollment

2,046

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 11-24•Study partner/caregiver required

Primary endpoints

•ADAS-Cog•The ADCS-CGIC score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDGV971-007
NCT IDNCT04520412

Timeline

Milestones

Study first posted2020-08-20actual
Study start2020-10-27actual
Last update posted2022-11-23actual
Primary completion2025-12estimated (month precision)
Study completion2026-10estimated (month precision)

Assets

Drug assets

Sodium oligomannate

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
3
Behavior / neuropsychiatric
2
Other clinical outcomes
2
Function / daily living
1
Neuroimaging
1
Caregiver / quality of life
1
Other (unclassified)
1

Global cognition

3 endpoints
Primary/protocol endpoint

Change from baseline in the ADAS-cog/11 score

Time frame:Baseline, 48 weeks and 52 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in MMSE score

Time frame:Baseline, 52 Weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Assess the efficacy of GV-971 throughout the OLE period

Time frame:Baseline, 52 Weeks, 78 Weeks

ADAS-Cog

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change from baseline in ADCS-ADL23 score

Time frame:Baseline, 36 Weeks, 52 Weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints
Secondary/protocol endpoint

Change from baseline in NPI score

Time frame:Baseline, 36 Weeks, 52 Weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in NPI caregiver items

Time frame:Baseline, 52 Weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Neuroimaging

1 endpoint
Other/protocol endpoint

Evaluate the effect of GV-971 on brain structure neurodegeneration

Time frame:Baseline, 52 Weeks

ratio, descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Change from baseline in ZBI score

Time frame:Baseline, 52 Weeks

change from baseline, improvement

Other clinical outcomes

2 endpoints
Primary/protocol endpoint

Change from baseline in the ADCS-CGIC score

Time frame:Baseline, 48 weeks and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Assess the efficacy of GV-971 throughout the OLE period

Time frame:Baseline, 52 Weeks, 78 Weeks

change from baseline, improvement

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

Evaluate the population PK

Time frame:Baseline, 12 Weeks, 24 Weeks, 52 Weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.