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Taking people in ChinaPhase 3

Tests butyphthalide in people with thinking problems after stroke

Compares butyphthalide with a placebo in adults with post-stroke thinking decline.

Key facts

Who runs it
Fudan University
Where
Dandong, ChinaSee the site
Trial code
Registry title
Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER)
Status
Recruiting
Phase
Phase 3
People taking part
3,200 people, planned
Started
Apr 2024
Expected to end
Dec 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • dl-3-butylphthalide
  • dl-3-butylphthalide placebo
Record updated
15 April 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 60 or older who recently had an acute ischemic stroke. It tests whether a drug lowers the risk of, and improves, thinking problems after stroke.

Age
60 years or older
Sex
All sexes can join.
Disease stage
First stage: acute ischemic stroke with symptoms starting within 14 days, confirmed by CT/MRI, with a baseline NIHSS score of 3-18. Second stage: people diagnosed with post-stroke cognitive impairment (PSCI) at stage I.
Earlier treatment
People who had thrombectomy, thrombolysis, carotid endarterectomy or other surgery during the acute stroke cannot join. People using cholinesterase inhibitors, NMDA receptor antagonists or Sodium oligomannate (GV-971) cannot join.

Main reasons for not taking part

  • Dementia diagnosed before the stroke
  • Other brain or nerve diseases or serious mental illness
  • Severe liver or kidney problems
  • Pregnancy, breastfeeding or planning pregnancy
  • Allergy to butylphthalein or taking part in another interventional trial

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients who had been diagnosed with dementia prior to stroke
  • Current known alcohol or illicit drug abuse or dependence
  • Patients undergoing thrombectomy, thrombolysis, carotid endarterectomy, or other surgical procedures during the acute infarction
  • 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
  • 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
  • The presence of a malignant tumor or other serious/life-threatening disease that could cause the subject's death within 12 months
  • Allergic to any component of butylphthalein
  • MRI contraindications (e.g., claustrophobia, hypersensitivity to contrast media, etc.); Second stage:
  • Recurrent stroke in the first stage
  • Using cholinesterase inhibitors, N-methyl-D-aspartate (NMDA) receptor antagonists, or Sodium oligomannate (GV-971)
  • First stage:
  • Uncorrectable visual and hearing impairments and inability to complete neuropsychological tests
  • Severe liver and kidney dysfunction
  • Pregnancy or lactation, have the possibility of becoming pregnant, and who plan to become pregnant
  • Participants in other interventional clinical trials

Where in China

  • Donggang Center HospitolDandong, ChinaContact: Lili wangTaking people

About the trial

What the trial wants to find out

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 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.

Read full original descriptionShow less

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 2 groups in the trial

  • dl-3-butylphthalideTreatment being tested

    Routine treatment and dl-3-butylphthalide

    Treatment: dl-3-butylphthalide and dl-3-butylphthalide placebo

  • dl-3-butylphthalide PlaceboPlacebo, for comparison

    Routine treatment and dl-3-butylphthalide Placebo

    Treatment: dl-3-butylphthalide and dl-3-butylphthalide placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER)
Plain-language title
Tests butyphthalide in people with thinking problems after strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
15 April 2024