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Study identifier: NCT05976152 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Stroke · Post-stroke Cognitive Impairment (PSCI)  ·  Sponsor: Fudan University

PhasePhase 3
Planned participants3200
Who can joinAll sexes, 60 Years to no upper limit
Healthy volunteersNo

About this study

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 recovery of conditions such as delirium and transient cognitive impairment after stroke, the diagnosis of PSCI often requires cognitive assessment at 12 to 24 weeks post-stroke to determine the severity of cognitive impairment. It can be classified according to the severity of cognitive impairment as post-stroke cognitive impairment no dementia (PSCIND) and post-stroke dementia (PSD). Recent large international cohort studies have reported an incidence rate of PSCI ranging from 24% to 53.4%, and patients with PSCI have a significantly higher mortality rate compared to those without cognitive impairment. Guidelines such as American Heart Association/American Society of Anesthesiologists (AHA/ASA) and the Chinese "Expert Consensus on the Management of Post-Stroke Cognitive Impairment" propose integrating cognitive impairment and stroke intervention strategies. Early comprehensive intervention and treatment for high-risk individuals after stroke, aiming to delay or prevent the progression from PSCIND to PSD, are the primary goals in the current treatment of PSCI. However, there is currently a lack of large randomized controlled trials (RCTs) for PSCI, and research is still needed to determine whether cognitive-enhancing drugs can reduce the risk of PSCI occurrence and improve outcomes and…

This description comes directly from the study's public registry record.

Talk to the study team

Qiang Dong  ·  +8602152887145  ·  dong_qiang@fudan.edu.cn

Always discuss trial participation with your own doctor first.

Locations (1)

Donggang Center HospitolDandong, Liaoning, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT05976152