Status:
RECRUITING
Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER)
Lead Sponsor:
Fudan University
Conditions:
Stroke
Post-stroke Cognitive Impairment (PSCI)
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
Post-stroke cognitive impairment (PSCI) refers to a clinical syndrome characterized by cognitive impairment that occurs after a stroke event and persists for at least 24 weeks. Due to the early recove...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
3200 Patients enrolled
Trial Details
Trial ID
NCT05976152
Start Date
April 1 2024
End Date
December 1 2026
Last Update
April 15 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Donggang Center Hospitol
Dandong, Liaoning, China