Sodium oligomannate to prevent cognitive decline after ischemic stroke
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
This will test whether taking sodium oligomannate can prevent cognitive problems in adults who recently had an ischemic stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 2 sites (Guangzhou, Baiyun and 1 other locations) |
| Trial ID | NCT05545605 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled, single-center study that enrolled 116 adults with a first ischemic stroke to compare sodium oligomannate versus placebo over a 6-month period. Participants were randomized 1:1 and received study medication or matching placebo, with safety checks at 4, 12, and 24 weeks and efficacy assessments at 12 and 24 weeks. Eligible patients were enrolled within 7 days of stroke onset, were able to cooperate with cognitive testing, and had MoCA scores below the study cutoff after education correction. The trial focuses on preventing post-stroke cognitive impairment by targeting gut microbiota-related mechanisms suggested in prior Alzheimer’s research.
Who should consider this trial
Good fit: Adults aged 18–80 with a first ischemic stroke within 7 days of onset, conscious and able to complete cognitive testing (NIHSS ≤15), with baseline cognitive screening below the study cutoff (MoCA corrected <22), and who can attend follow-up visits at the study site.
Not a fit: People with severe neurologic deficits, pre-existing neurodegenerative disease or other major brain disorders, inability to cooperate with testing, onset beyond 7 days, or who live too far to attend the scheduled in-person visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the treatment could lower the risk of post-stroke cognitive impairment and help preserve daily functioning after ischemic stroke.
How similar studies have performed: Sodium oligomannate has shown cognitive benefits in mild-to-moderate Alzheimer's disease, but its use specifically to prevent post-stroke cognitive impairment is largely untested and requires larger trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Baiyun and 1 other locations
- Nanfang Hospital, Southern Medical University — Guangzhou, Baiyun, China (Recruiting)
- Nanfang Hospital,Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Jia Yin, M.D
- Email: jiajiayin@139.com
- Phone: 13802964883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.