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Efficacy and Safety of Donepezil and Sodium Oligomannate in Patients With Mild to Moderate Alzheimer's Disease

Assets

Donepezil / Sodium oligomannate

Listed sites

0

Recruiting sites

-

Enrollment

150

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE ≤26

Primary endpoint

•ADAS-Cog

Identifiers

Registered as

NCT IDNCT05114499
Org study IDXJTU1AF2021LSK-328

Timeline

Milestones

Study first posted2021-11-10actual
Last update posted2021-11-10actual
Study start2021-12estimated (month precision)
Primary completion2023-12estimated (month precision)
Study completion2024-12estimated (month precision)

Assets

Drug assets

DonepezilSodium 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 50-85 years old , either sex;
•met the diagnostic criteria for suspected AD;
•mild to moderate AD patients, that is, patients with 11 points ≤Mini-Mental State Examination(MMSE) total score ≤26 points
•total Hachinski ischemic scale (HIS) score ≤4 points;
•memory loss for at least 12 months, with a tendency of progressive deterioration;
•brain magnetic resonance imaging（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 (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy, etc.);
•mental illness according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition（DSM-IV), Text Revision criteria, including schizophrenia and other mental illness, bipolar disorder, and severe depression or paralysis;
•unstable or severe heart, lung, liver, kidney, or hematopoietic diseases;
•uncorrectable visual and auditory disorders that affected completing neuropsychological tests and scale assessments;
•simultaneous use of cholinesterase inhibitors or memantine.

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

ADAS-Cog

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.