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RecruitingPhase NA

Efficacy and Safety of Sodium Oligomannate in the Prevention of PSCI

Efficacy and Safety of Sodium Oligomannate in the Prevention of Post-stroke Cognitive Impairment in Patients With Ischemic Stroke:a Randomized, Double-blind, Exploratory Controlled Study

Asset

Sodium oligomannate

Listed sites

2

Recruiting sites

1

Enrollment

116

estimated

Study population

Vascular cognitive impairment / dementia

Key I/E criterion

•MoCA ≤22

Primary endpoint

•Montreal Cognitive Assessment (MoCA)

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

NCT IDNCT05545605
Org study IDNFEC-2022-276

Timeline

Milestones

Study first posted2022-09-19actual
Study start2023-04-01actual
Last update posted2025-06-13actual
Primary completion2025-12-31estimated
Study completion2025-12-31estimated

Assets

Drug assets

Sodium oligomannate

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•1.The first occurrence of ischemic stroke, which met the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, was confirmed by CT or MR; 2. The onset of illness was less than 7 days after admission, aged 18-80 years; 3. Clear consciousness, able to cooperate with cognitive and other tests, NIHSS score ≤15; 4. Before onset, the patient's cognitive level was normal, daily life and social activities were normal; 5. Stay in the current place of residence for more than 3 years; 6. With cognitive assessment, MoCA < 22 (years of education < 12, +1) after correction, and signed the informed consent

Exclusion criteria

•1.Unable to cooperate with neuropsychological examination due to various reasons (such as consciousness disorders, vision disorders, hearing disorders, etc.); 2. Combined with other diseases (such as intracranial mass, demyelinating disease, intracranial infection, neurodegenerative disease, epilepsy, severe heart, liver, kidney, blood system or other system diseases, etc.); 3. Used antibiotics 3 months before onset; 4. A history of alcohol abuse, drug use, or serious mental illness (including major depression (HAMD > 10)) before onset of illness, 5. No stool was collected within 7 days of onset.

Endpoints (4)

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
Safety / tolerability / PK
1

Global cognition

3 endpoints
Primary/protocol endpoint

Incidence of PSCI

Time frame:6 months

Montreal Cognitive Assessment (MoCA)

threshold achievement, improvement

Secondary/protocol endpoint

The difference of MoCA value from cardinality

Time frame:6 months

Montreal Cognitive Assessment (MoCA)

descriptive

Secondary/protocol endpoint

Differences in ADAS-cog values from cardinality

Time frame:6 months

ADAS-Cog

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence of adverse events

Time frame:6 months

threshold achievement, 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.