Butyphthalide's effect on cognitive recovery after stroke
Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER)
This study is testing if a new medication called butyphthalide can help improve thinking and memory in older adults who have had a stroke.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 3200 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Dandong, Liaoning) |
| Trial ID | NCT05976152 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of dl-3-butylphthalide on cognitive function in patients who have experienced an acute ischemic stroke. Participants aged 60 and older will be assessed for cognitive impairment at least 12 weeks post-stroke, with a focus on those diagnosed with post-stroke cognitive impairment (PSCI). The study involves a randomized control design, comparing the effects of butyphthalide against a placebo. The goal is to determine if butyphthalide can improve cognitive outcomes in this patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 and older who have experienced an acute ischemic stroke within the last 14 days and have been diagnosed with post-stroke cognitive impairment.
Not a fit: Patients with a prior diagnosis of dementia or other serious conditions affecting cognitive function may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance cognitive recovery and quality of life for stroke survivors suffering from cognitive impairment.
How similar studies have performed: Other studies have shown promising results with similar interventions targeting cognitive recovery post-stroke, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: First stage: * Acute ischemic stroke (AIS) symptom onset within 14 days Signs and symptoms consistent with the diagnosis of an acute ischemic stroke by CT/MRI. * Age \>= 60 years， * Baseline NIHSS 3-18. * Patient can complete questionnaire survey, physical examination, cranial MRI and other medical examinations * Patient/legally authorized representative has signed the Informed Consent Form Second stage: * Patient with stage I diagnosis of PSCI. * Patient can complete questionnaire survey, physical examination, cranial MRI and other medical examinations. * Patient/legally authorized representative has signed the Informed Consent Form Exclusion Criteria: First stage: * Patients who had been diagnosed with dementia prior to stroke * Other related factors affecting cognitive function: central nervous system infection, neurodegenerative diseases, trauma, poisoning, intracranial space occupying lesions, metabolic diseases, etc. * Other serious central nervous system diseases: Parkinson's disease, epilepsy, multiple sclerosis, motor neurone disease, immune-related encephalomyelopathy, etc. * Serious mental illness: anxiety disorder, depression, delirium, schizophrenia, bipolar disorder, mental retardation, which is diagnosed or controlled by medication. * Uncorrectable visual and hearing impairments and inability to complete neuropsychological tests * Severe liver and kidney dysfunction * The presence of a malignant tumor or other serious/life-threatening disease that could cause the subject's death within 12 months. * Current known alcohol or illicit drug abuse or dependence * Patients undergoing thrombectomy, thrombolysis, carotid endarterectomy, or other surgical procedures during the acute infarction. * Using cholinesterase inhibitors, N-methyl-D-aspartate (NMDA) receptor antagonists, or Sodium oligomannate (GV-971). * Allergic to any component of butylphthalein * Pregnancy or lactation, have the possibility of becoming pregnant, and who plan to become pregnant * Participants in other interventional clinical trials * MRI contraindications (e.g., claustrophobia, hypersensitivity to contrast media, etc.) Second stage: * During the first phase of follow-up, participants' compliance was poor, with study medication compliance less than 80% or greater than 120%; Follow-up was less than 24 weeks or did not complete the follow-up within the follow-up window.. * Recurrent stroke in the first stage
Where this trial is running
Dandong, Liaoning
- Donggang Center Hospitol — Dandong, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Qiang Dong
- Email: dong_qiang@fudan.edu.cn
- Phone: +8602152887145
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.