Efficacy and Safety of Sodium Oligomannate in the Prevention of PSCI

NCT05545605 | Recruiting

• 1 other identifier: NFEC-2022-276
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

Brief Summary

Post-stroke cognitive impairment (PSCI) is a common complication of stroke, and seriously affect the quality of survival and the survival time in patients with stroke, PSCI is still lack of effective prevention and treatment measures, the study found that gut microbiota are closely associated with stroke and cognitive diseases, sodium oligomannate can improve cognitive function of mild-to-moderate alzheimer's disease (AD) , The Expert Consensus 2021 on the Management of Post-stroke cognitive impairment states that the role of sodium oligomannate in PSCI needs to be investigated in large sample clinical trials. This study intends to explore the efficacy and safety of sodium oligomannate in the prevention of PSCI in patients with acute ischemic stroke and cognitive impairment, so as to provide a potential intervention for the prevention of PSCI.

Conditions

Ischemic Stroke

Keywords

Post-stroke cognitive impairment; gut microbiota; Sodium oligomannate

Outcome Measures

Primary Outcomes (1)

• Incidence of PSCI

  Proportion of patients in both groups with a corrected MoCA score of \< 22 at 24 weeks of medication

  6 months

Secondary Outcomes (3)

• Incidence of adverse events

  6 months

• The difference of MoCA value from cardinality

  6 months

• Differences in ADAS-cog values from cardinality

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Subjects randomized to the trial group will receive sodium oligomannate 450mg twice daily for 24 weeks.

Drug: Sodium oligomannate

Control group

PLACEBO COMPARATOR

Subjects randomized to the control group will receive a 450mg placebo capsule twice daily for 24 weeks that has exactly the same appearance and smell as the Intervention group.

Drug: Placebo capsule

Interventions

Sodium oligomannate DRUG

Patients with acute ischemic stroke were recruited, and after signing informed consent, those who met the inclusion/exclusion criteria were randomly assigned in a 1:1 ratio to receive treatment in the trial group (receiving sodium oligomannate)

Intervention group

Placebo capsule DRUG

the control group (receiving placebo capsule) for 24 weeks.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (2)

Nanfang Hospital, Southern Medical University

Guangzhou, Baiyun, 510515, China

RECRUITING

Nanfang Hospital,Southern Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jia Yin, M.D

CONTACT

13802964883; jiajiayin@139.com

Yiting Deng, M.D

CONTACT

15625070887; 751771431@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistical researchers from the partner Shanghai Green Valley Pharmaceutical Co., LTD., used statistical software packages to generate two sets of 58 random drug numbers, which were determined in the form of files after the codes were formed.Masking the participant and investigator.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 19, 2022
• Study Start: April 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

CN (2)