Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER)

Launched by FUDAN UNIVERSITY · Jul 27, 2023

Keywords

ClinConnect Summary

The Be-CLEVER trial is a clinical study designed to evaluate how effective a medication called donepezil is in helping patients recover from cognitive problems after a stroke. These cognitive issues, known as post-stroke cognitive impairment (PSCI), can affect thinking and memory and may occur in many stroke survivors. The trial will take place over 48 weeks and involve two main phases. In the first phase, researchers will look at whether donepezil can lower the chances of developing PSCI shortly after a stroke. In the second phase, they will assess if donepezil can improve cognitive function in patients already showing signs of PSCI.

To participate in this trial, individuals must be at least 60 years old and have had an acute ischemic stroke within the past two weeks. They should not have been diagnosed with dementia before the stroke and must be able to complete various assessments like questionnaires and MRI scans. Participants will receive either donepezil or a placebo (a non-active treatment) for the duration of the study. Throughout the trial, patients can expect regular check-ins to monitor their health and cognitive progress. This study aims to provide valuable insights into improving the lives of stroke survivors facing cognitive challenges.

Gender

ALL

Eligibility 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