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Active not recruitingPhase 4

Long-term Efficacy and Safety Study of GV-971

A Clinical Study to Evaluate the Long-term Efficacy and Safety of Sodium Oligomannate Capsules (GV-971)

Asset

Sodium oligomannate

Listed sites

40

Recruiting sites

-

Enrollment

800

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 11-26

Primary endpoint

•ADAS-Cog

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-PMS-B
NCT IDNCT05181475

Timeline

Milestones

Study start2021-12-07actual
Study first posted2022-01-06actual
Last update posted2024-11-15actual
Primary completion2025-01estimated (month precision)
Study completion2025-06estimated (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

1. Aged 50 to 85 years (inclusive), with no restriction on gender;

2. Patients who met criteria for "probable AD" by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria;

3. Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive;

4. Patients who have received at least primary education and have capacity to complete the measurement of cognition and other tests as specified in the protocol;

5. Patients receiving GV-971 treatment prescribed by clinicians;

6. Sign the informed consent form

Exclusion criteria

1. Patients who have received GV-971 treatment within 6 months prior to screening;

2. Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;

3. Female participants who are pregnant or lactating;

4. Patients who cannot cooperate to complete the follow-up inquiries;

5. Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.

Endpoints (5)

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
Function / daily living
1
Safety / tolerability / PK
1

Global cognition

3 endpoints
Primary/protocol endpoint

Change from baseline in the ADAS-cog/11 score

Time frame:Baseline, 48 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in ADAS-Cog/11 score

Time frame:Baseline, 96 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in MMSE score

Time frame:Baseline, 48 weeks, 96 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change from baseline in ADCS-ADL score

Time frame:Baseline, 48 weeks, 96 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame:48 weeks, 96 weeks

event count, event

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.