Efficacy and Safety of Sodium Oligomannate in the Prevention of PSCI

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05545605
• Other study ID #: NFEC-2022-276
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jia Yin, M.D
• Phone: 13802964883
• Email: jiajiayin[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This clinical study was a randomized (1:1), double-blind, single-center, parallel controlled clinical study. The study period was 6 months to evaluate the efficacy and safety of sodium oligomannate in the prevention of PSCI in patients with ischemic stroke. Patients with acute ischemic stroke were recruited. After signing informed consent, patients who met the inclusion/exclusion criteria were randomly assigned in a 1:1 ratio to receive treatment in the trial group (receiving sodium oligomannate) or the control group (receiving placebo capsule). A total of 116 patients were enrolled.And safety assessment and survival follow-up were performed at 4 weeks, 12 weeks and 24 weeks, and efficacy assessment was performed at 12 weeks and 24 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• Sodium oligomannate
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)
• Placebo capsule
the control group (receiving placebo capsule) for 24 weeks.

Locations

Country	Name	City	State
China	Nanfang Hospital,Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of PSCI	Proportion of patients in both groups with a corrected MoCA score of < 22 at 24 weeks of medication	6 months
Secondary	Incidence of adverse events	The proportion of patients who had any adverse effect during the study period	6 months
Secondary	The difference of MoCA value from cardinality	The difference between the MoCA value at 24 weeks of medication and the MoCA value at enrollment	6 months
Secondary	Differences in ADAS-cog values from cardinality	The difference between the ADAS-cog value at 24 weeks of medication and the ADAS-cog value at enrollment.	6 months