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UnknownPhase 4

Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Assets

Memantine / Sodium oligomannate

Listed sites

Recruiting sites

Enrollment

150

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•MMSE ≤14

Primary endpoint

•Cognitive function

Identifiers

Registered as

NCT IDNCT05430867

Org study IDXJTU1AF2022LSK-042

Timeline

Milestones

Study first posted2022-06-24actual

Study start2022-07-01estimated

Last update posted2022-07-07actual

Primary completion2024-07-01estimated

Study completion2024-12-31estimated

Assets

Drug assets

Memantine Sodium oligomannate

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•age of 50-80 years old , either sex;

•met the diagnostic criteria for suspected AD;

•moderate to severe AD patients(5 points ≤Mini-Mental State Examination total score≤14 points);

•total Hachinski ischemic scale (HIS) score ≤4 points;

•memory loss for at least 12 months, with a progressive deterioration;

•brain MRI scan suggesting a significant possibility of AD;

•no obvious physical signs during nervous system examination;

•stable and reliable caregivers;

•elementary school or higher education level;

•signed an informed consent form

Exclusion criteria

•previous nervous system diseases ;

•mental illness;

•unstable or severe heart, lung, liver, kidney, or hematopoietic diseases;

•uncorrectable visual and auditory disorders;

•simultaneous use of cholinesterase inhibitors, memantine or GV-971.

Endpoints (1)

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.

Global cognition

1 endpoint

Primary/protocol endpoint

cognitive function

Time frame:baseline, week 12, week 24, week 36,week 48

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.