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RecruitingPhase 4

An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease

A 36-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease

Asset

Sodium oligomannate

Listed sites

50

Recruiting sites

12

Enrollment

1,312

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•ADCS-Activities of Daily Living (ADCS-ADL)

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 IDGV-971-PoCT
NCT IDNCT05908695

Timeline

Milestones

Study first posted2023-06-18actual
Study start2023-08-31actual
Last update posted2023-11-09actual
Primary completion2029-06estimated (month precision)
Study completion2029-12estimated (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.
•Hachinski Ischemic Score (HIS) scale total score ≤ 4.
•Hamilton Rating Scale for Depression/17 items (HAMD) total score ≤ 10.
•Brain MRI scan show the highest possibility of AD.
•Have a reliable study partner/caregiver.
•Sign the informed consent form

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 10 minutes of rest.
•Major medical illness or unstable medical condition within 12 months of screening.
•Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline.
•Inadequate hepatic function.
•Inadequate organ function.
•ECG clinically significant abnormalities.

Endpoints (9)

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
2
Function / daily living
2
Fluid / digital biomarkers
2
Behavior / neuropsychiatric
1
Other clinical outcomes
1
Other (unclassified)
1

Global cognition

2 endpoints
Primary/protocol endpoint

Change from baseline in the ADAS-cog/12 score

Time frame:Baseline, 36 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in MMSE score

Time frame:Baseline, 36 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

2 endpoints
Primary/protocol endpoint

Change from baseline in ADCS-ADL23 score

Time frame:Baseline, 36 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in ADCS-ADL23 score

Time frame:Baseline, 36 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Change from baseline in NPI score

Time frame:Baseline, 36 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Fluid / digital biomarkers

2 endpoints
Other/protocol endpoint

Change from baseline on A-beta protein of CSF

Time frame:Baseline, 36 weeks

change from baseline, improvement

Other/protocol endpoint

Change from baseline on Tau protein of CSF

Time frame:Baseline, 36 weeks

change from baseline, improvement

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Change from baseline in the CIBIC-Plus score

Time frame:Baseline, 36 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

Change from baseline on biomarkers of Th1/Th2 cell subtypes

Time frame:Baseline, 36 weeks

change from baseline, improvement

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.