Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05976152
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2023-07-06
Brief Title:
Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial Be-CLEVER
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial Be-CLEVER
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Be-CLEVER
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 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 534 and patients with PSCI have a significantly higher mortality rate compared to those without cognitive impairment Guidelines such as American Heart AssociationAmerican Society of Anesthesiologists AHAASA 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 prognosis for PSCI patients A randomized double-blind multicenter clinical study involving 281 non-dementia vascular cognitive impairment VCI patients showed that the overall cognitive scores of patients treated with donepezil for 24 weeks significantly improved compared to the placebo group
The aim of this study is to evaluate the effectiveness of donepezil in the treatment of post-stroke cognitive impairment It will be a multicenter randomized double-blind placebo-controlled trial with a 48-week treatment duration The study will observe the difference in PSCI incidence rate between the donepezil treatment group and the conventional stroke treatment group at 24 weeks and evaluate the improvement in post-stroke cognitive impairment after 6 months of donepezil treatment compared to conventional treatment
This study will be conducted in two stages the first stage 0-24 weeks aims to assess whether donepezil can reduce the risk of PSCI occurrence and will be a multicenter randomized double-blind placebo-controlled study The second stage 24-48 weeks aims to evaluate whether donepezil can improve the prognosis of PSCI patients and will also be a multicenter randomized double-blind placebo-controlled study
The aim of this study is to evaluate the effectiveness of donepezil in the treatment of post-stroke cognitive impairment It will be a multicenter randomized double-blind placebo-controlled trial with a 48-week treatment duration The study will observe the difference in PSCI incidence rate between the donepezil treatment group and the conventional stroke treatment group at 24 weeks and evaluate the improvement in post-stroke cognitive impairment after 6 months of donepezil treatment compared to conventional treatment
This study will be conducted in two stages the first stage 0-24 weeks aims to assess whether donepezil can reduce the risk of PSCI occurrence and will be a multicenter randomized double-blind placebo-controlled study The second stage 24-48 weeks aims to evaluate whether donepezil can improve the prognosis of PSCI patients and will also be a multicenter randomized double-blind placebo-controlled study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None