What is this study trying to find out about post-stroke cognitive impairment?

This study is evaluating whether the drug dl-3-butylphthalide can reduce the risk of cognitive problems after stroke and improve cognitive function when combined with standard treatments like donepezil. Researchers aim to understand if this treatment can help delay or prevent worsening cognitive impairment. The trial is led by Fudan University and involves multiple centers.

Who may be eligible for this post-stroke cognitive impairment clinical trial?

Adults aged 60 or older who have had an acute ischemic stroke within 14 days and can complete cognitive and medical assessments may be eligible. People with prior dementia, certain other brain diseases, or severe health issues are excluded. This trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this post-stroke cognitive impairment clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 60Years +

All Genders

ID05976152

Study of dl-3-butylphthalide to Improve Cognitive Function After Stroke in Older Adults A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial

Led by Fudan University · Updated on 2024-04-15

3200

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Post-stroke cognitive impairment PSCI is a condition where cognitive problems occur after a stroke and last for at least 24 weeks. It includes mild cognitive issues without dementia PSCIND and more severe dementia PSD. PSCI affects a significant number of stroke survivors and is linked to higher mortality. Current guidelines recommend early intervention to prevent progression, but more research is needed to see if cognitive-enhancing drugs can reduce PSCI risk and improve outcomes. This trial studies the drug dl-3-butylphthalide in patients aged 60 and older who have had an acute ischemic stroke. The study includes two stages over 48 weeks. In the first 24 weeks, participants receive either dl-3-butylphthalide or a placebo along with standard stroke treatments. After a 14-day washout, during the next 24 weeks, all patients receive donepezil plus either dl-3-butylphthalide or placebo to assess improvements in cognitive function. Participants will undergo cognitive assessments and brain MRI scans at baseline, 24 weeks, and 48 weeks. Researchers will measure PSCI occurrence at 24 weeks and changes in cognitive scores like VADAS-Cog, MoCA, MMSE, and others. Additional evaluations include neuropsychiatric symptoms, anxiety, depression, daily living activities, stroke recurrence, and functional status. The study is randomized, double-blind, placebo-controlled, and aims to evaluate the effects of dl-3-butylphthalide on cognitive changes after stroke.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 60Years +

All Genders

Eligibility Criteria

You may qualify if you...

Acute ischemic stroke symptom onset within 14 days confirmed by CT or MRI
Age 60 years or older
Baseline NIH Stroke Scale score between 3 and 18
Ability to complete questionnaires, physical exams, and cranial MRI
Signed informed consent by patient or legal representative
Diagnosis of stage I post-stroke cognitive impairment for second stage
Ability to complete necessary assessments and signed informed consent for second stage

You will not qualify if you...

Prior diagnosis of dementia before stroke
Other factors affecting cognition such as CNS infections, neurodegenerative diseases, trauma, poisoning, brain lesions, metabolic diseases
Serious CNS diseases like Parkinson's, epilepsy, multiple sclerosis, motor neuron disease, immune encephalomyelopathy
Severe mental illness diagnosed or controlled by medication including anxiety, depression, delirium, schizophrenia, bipolar disorder, mental retardation
Uncorrectable vision or hearing impairments preventing neuropsychological tests
Severe liver or kidney dysfunction
Malignant tumor or life-threatening disease expected to cause death within 12 months
Current alcohol or illicit drug abuse or dependence
Undergoing thrombectomy, thrombolysis, carotid surgery during acute infarction
Use of cholinesterase inhibitors, NMDA receptor antagonists, or Sodium oligomannate
Allergy to any component of butylphthalein
Pregnancy, lactation, or planning pregnancy
Participation in other interventional clinical trials
MRI contraindications like claustrophobia or contrast hypersensitivity
Poor compliance or less than 80% medication adherence during first phase
Recurrent stroke in first stage

Research Team

Qiang Dong

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Study of dl-3-butylphthalide to Improve Cognitive Function After Stroke in Older Adults A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria