Study of Edaravone Dexborneol Sublingual Tablets to Treat Cognitive Problems After Acute Ischemic Stroke in Adults Aged 40 to 80

What this Trial Is About

Researchers are evaluating the safety and effectiveness of edaravone dexborneol sublingual tablets for treating cognitive problems after a stroke in adults aged 40 to 80 years. This exploratory Phase II clinical trial is randomized, double-blind, and placebo-controlled, aiming to compare outcomes between patients receiving the study drug and those receiving a placebo. The study focuses on patients who have had an acute ischemic stroke and developed cognitive impairment. Participants will be randomly assigned to receive either edaravone dexborneol sublingual tablets or a placebo twice daily for 24 weeks. Both groups will follow the same treatment schedule over this period. The trial will monitor and compare the safety and effectiveness of the tablet by assessing cognitive function and other health measures. During the study, participants will undergo evaluations including cognitive tests such as the Vascular Dementia Assessment Scale-cognitive subscale, Mini-Mental State Examination, and Montreal Cognitive Assessment at various times up to 24 weeks. Researchers will also track adverse events, treatment discontinuations, and other stroke-related scales. The total follow-up period for safety monitoring extends to 26 weeks, including after treatment completion or early withdrawal.

Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients