StrokePhase 3Be-CLEVERNCT05976152
Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER)
A Phase 3 study testing dl-3-butylphthalide in people with Stroke and Post-stroke Cognitive Impairment (PSCI), run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Stroke, Post-stroke Cognitive Impairment (PSCI)
- What is being tested?
- dl-3-butylphthalide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2024to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 join
- First stage:
- Patients who had been diagnosed with dementia prior to stroke
- 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.
- Uncorrectable visual and hearing impairments and inability to complete neuropsychological tests
Show all 18Show fewer
- Severe liver and kidney dysfunction
- The presence of a malignant tumor or other serious/life-threatening disease that could cause the subject's death within 12 months.
- Current known alcohol or illicit drug abuse or dependence
- Patients undergoing thrombectomy, thrombolysis, carotid endarterectomy, or other surgical procedures during the acute infarction.
- Using cholinesterase inhibitors, N-methyl-D-aspartate (NMDA) receptor antagonists, or Sodium oligomannate (GV-971).
- Allergic to any component of butylphthalein
- Pregnancy or lactation, have the possibility of becoming pregnant, and who plan to become pregnant
- Participants in other interventional clinical trials
- MRI contraindications (e.g., claustrophobia, hypersensitivity to contrast media, etc.)
- Second stage:
- 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..
- Recurrent stroke in the first stage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Donggang Center Hospitol
Dandong, Liaoning
Lili wang, 15842554006
Jing Li
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 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.
- Conditions
- Stroke, Post-stroke Cognitive Impairment (PSCI)
- Being tested
- dl-3-butylphthalide, dl-3-butylphthalide placebo
- Keywords
- stroke, PSCI, Butylphthalide
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dl-3-butylphthalideDrug
Also called DL-3-n-butylphthalide (NBP)
First stage： Routine stroke treatment: hypoglycemic, antihypertensive, antiplatelet, anticoagulant and other conventional cerebrovascular disease treatment drugs.
Placebo group: routine stroke treatment + oral Butylphthalide Placebo Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.
Butylphthalide group: routine stroke treatment + oral Butylphthalide Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.
Second stage： 14d washout period after first stage. Routine PSCI treatment: 5-10 mg Donepezil, qd. Placebo group: Routine PSCI treatment + oral Butylphthalide Placebo Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.
Butylphthalide group:
Routine PSCI treatment + oral Butylphthalide Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.
dl-3-butylphthalide placeboDrug
Also called NBP placebo
First stage： Routine stroke treatment: hypoglycemic, antihypertensive, antiplatelet, anticoagulant and other conventional cerebrovascular disease treatment drugs.
Placebo group: routine stroke treatment + oral Butylphthalide Placebo Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.
Butylphthalide group: routine stroke treatment + oral Butylphthalide Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.
Second stage： 14d washout period after first stage. Routine PSCI treatment: 5-10 mg Donepezil, qd. Placebo group: Routine PSCI treatment + oral Butylphthalide Placebo Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.
Butylphthalide group:
Routine PSCI treatment + oral Butylphthalide Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| dl-3-butylphthalide | Experimental | Routine treatment and dl-3-butylphthalide Receives: Drug: dl-3-butylphthalide; Drug: dl-3-butylphthalide placebo |
| dl-3-butylphthalide Placebo | Placebo comparator | Routine treatment and dl-3-butylphthalide Placebo Receives: Drug: dl-3-butylphthalide; Drug: dl-3-butylphthalide placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSCI incidence
Compared with routine stroke treatment, the difference of the PSCI incidence at 24 weeks with butylphthalide treatment.
Measured: 24 weeks (first stage)
vadas-cog score
Compared with routine treatment, improvement of vadas-cog scores at 24 weeks with butylphthalide treatment
Measured: 6 months (Second stage)
Secondary outcomes (22)
Changes of Montreal Cognitive Assessment (MoCA) at 24 weeks compared with baseline
Changes of Montreal Cognitive Assessment (MoCA) at 24 weeks compared with baseline
Measured: 24 weeks (first stage)
Changes of Mini-Mental State Examination (MMSE) at 24 weeks compared with baseline
Changes of Mini-Mental State Examination (MMSE) at 24 weeks compared with baseline
Measured: 24 weeks (first stage)
Changes of Neuropsychiatric Inventory Questionnaire (NPI-Q) at 24 weeks compared with baseline
Changes of Neuropsychiatric Inventory Questionnaire (NPI-Q) at 24 weeks compared with baseline
Measured: 24 weeks (first stage)
Changes of Hamilton Anxiety Scale (HAMA) at 24 weeks compared with baseline
Changes of Hamilton Anxiety Scale (HAMA) at 24 weeks compared with baseline
Measured: 24 weeks (first stage)
Changes of Hamilton Depression Scale (HAMD) at 24 weeks compared with baseline
Changes of Hamilton Depression Scale (HAMD) at 24 weeks compared with baseline
Measured: 24 weeks (first stage)
Changes of 23-item version of Alzheimer's Disease Cooperative Study- activities of daily living scale (ADCS-ADL23) for activities of daily living at 24 weeks compared with baseline
Changes of 23-item version of Alzheimer's Disease Cooperative Study- activities of daily living scale (ADCS-ADL23) for activities of daily living at 24 weeks compared with baseline
Measured: 24 weeks (first stage)
Changes of Clinical Dementia Rating (CDR) at 24 weeks compared with baseline
Changes of Clinical Dementia Rating (CDR) at 24 weeks compared with baseline
Measured: 24 weeks (first stage)
Changes of infarct volume by cranial magnetic resonance imaging (MRI) at 24 weeks after treatment with butylphthalein compared with routine stroke treatment.
Changes of infarct volume by cranial magnetic resonance imaging (MRI) at 24 weeks after treatment with butylphthalein compared with routine stroke treatment.
Measured: 24 weeks (first stage)
Changes of infarct location by cranial magnetic resonance imaging (MRI) at 24 weeks after treatment with butylphthalein compared with routine stroke treatment.
Changes of infarct location by cranial magnetic resonance imaging (MRI) at 24 weeks after treatment with butylphthalein compared with routine stroke treatment.
Measured: 24 weeks (first stage)
stroke recurrence
Difference in stroke recurrence rate of butylphthalein treatment compared with routine stroke treatment at 24 weeks
Measured: 24 weeks (first stage)
Changes of modified Rankin Scale score (mRS) at 24 weeks compared with baseline.
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The mRS is a range from 0-6. 0=No symptoms, 1=No significant disability. Able to carry out all usual activities, despite some symptoms. 2=Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3=Moderate disability. Requires some help, but able to walk unassisted. 4=Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5=Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6=Dead
Measured: 24 weeks (first stage)
Changes of Montreal Cognitive Assessment (MoCA) at 48 weeks compared with baseline
Changes of Montreal Cognitive Assessment (MoCA) at 48 weeks compared with baseline
Measured: 48 weeks (second stage)
Changes of Mini-Mental State Examination (MMSE) at 48 weeks compared with baseline
Changes of Mini-Mental State Examination (MMSE) at 48 weeks compared with baseline
Measured: 48 weeks (second stage)
Changes cognitive domain level by Symbol Digit Modalities Test at 48 weeks compared with baselinel
Changes cognitive domain level by Symbol Digit Modalities Test at 48 weeks compared with baseline
Measured: 48 weeks (second stage)
Changes cognitive domain level by Trail Making Test at 48 weeks compared with baseline.
Changes cognitive domain level by Trail Making Test at 48 weeks compared with baseline.
Measured: 48 weeks (second stage)
Changes of Neuropsychiatric Inventory Questionnaire (NPI-Q) at 48 weeks compared with baseline
Changes of Neuropsychiatric Inventory Questionnaire (NPI-Q) at 48 weeks compared with baseline
Measured: 48 weeks (second stage)
Changes of Hamilton Anxiety Scale (HAMA) at 48 weeks compared with baseline
Changes of Hamilton Anxiety Scale (HAMA) at 48 weeks compared with baseline
Measured: 48 weeks (second stage)
Changes of Hamilton Depression Scale (HAMD) at 48 weeks compared with baseline
Changes of Hamilton Depression Scale (HAMD) at 48 weeks compared with baseline
Measured: 48 weeks (second stage)
Changes of Clinical Dementia Rating (CDR) at 48 weeks compared with baseline
Changes of Clinical Dementia Rating (CDR) at 48 weeks compared with baseline
Measured: 48 weeks (second stage)
Changes of 23-item version of Alzheimer's Disease Cooperative Study- activities of daily living scale (ADCS-ADL23) for activities of daily living at 48 weeks compared with baseline
Changes of 23-item version of Alzheimer's Disease Cooperative Study- activities of daily living scale (ADCS-ADL23) for activities of daily living at 48 weeks compared with baseline
Measured: 48 weeks (second stage)
stroke recurrence
Difference in stroke recurrence rate of butylphthalein treatment compared with routine stroke treatment at 48 weeks
Measured: 48 weeks (second stage)
Changes of mRS at 48 weeks compared with baseline.
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The mRS is a range from 0-6. 0=No symptoms, 1=No significant disability. Able to carry out all usual activities, despite some symptoms. 2=Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3=Moderate disability. Requires some help, but able to walk unassisted. 4=Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5=Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6=Dead
Measured: 48 weeks (second stage)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study startApr 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Dong, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976152
- Sponsor's protocol ID
- Be-CLEVER
- Acronym
- Be-CLEVER
- Status last verified
- Apr 2024
- First submitted
- 6 Jul 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER)
- ClinicalTrials.gov ID
- NCT05976152
- Acronym / sponsor ID
- Be-CLEVER / Be-CLEVER
- Conditions
- Stroke, Post-stroke Cognitive Impairment (PSCI)
- Keywords
- stroke, PSCI, Butylphthalide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dl-3-butylphthalide | Experimental | Drug: dl-3-butylphthalide, Drug: dl-3-butylphthalide placeboRoutine treatment and dl-3-butylphthalide |
| dl-3-butylphthalide Placebo | Placebo comparator | Drug: dl-3-butylphthalide, Drug: dl-3-butylphthalide placeboRoutine treatment and dl-3-butylphthalide Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- Patients who had been diagnosed with dementia prior to stroke
- 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.
- Uncorrectable visual and hearing impairments and inability to complete neuropsychological tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dl-3-butylphthalideAlso: DL-3-n-butylphthalide (NBP)First stage： Routine stroke treatment: hypoglycemic, antihypertensive, antiplatelet, anticoagulant and other conventional cerebrovascular disease treatment drugs. Placebo group: routine stroke treatment + oral Butylphthalide Placebo Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks. Butylphthalide group: routine stroke treatment + oral Butylphthalide Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks. Second stage： 14d washout period after first stage. Routine PSCI treatment: 5-10 mg Donepezil, qd. Placebo group: Routine PSCI treatment + oral Butylphthalide Placebo Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks. Butylphthalide group: Routine PSCI treatment + oral Butylphthalide Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks. | Drug | dl-3-butylphthalide, dl-3-butylphthalide Placebo |
| dl-3-butylphthalide placeboAlso: NBP placeboFirst stage： Routine stroke treatment: hypoglycemic, antihypertensive, antiplatelet, anticoagulant and other conventional cerebrovascular disease treatment drugs. Placebo group: routine stroke treatment + oral Butylphthalide Placebo Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks. Butylphthalide group: routine stroke treatment + oral Butylphthalide Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks. Second stage： 14d washout period after first stage. Routine PSCI treatment: 5-10 mg Donepezil, qd. Placebo group: Routine PSCI treatment + oral Butylphthalide Placebo Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks. Butylphthalide group: Routine PSCI treatment + oral Butylphthalide Soft Capsules, 2 capsules/time, tid, an empty stomach for 24 weeks. | Drug | dl-3-butylphthalide, dl-3-butylphthalide Placebo |
Primary outcome
PSCI incidence
Time frame: 24 weeks (first stage)
Compared with routine stroke treatment, the difference of the PSCI incidence at 24 weeks with butylphthalide treatment.
vadas-cog score
Time frame: 6 months (Second stage)
Compared with routine treatment, improvement of vadas-cog scores at 24 weeks with butylphthalide treatment
22 secondary outcomes
Changes of Montreal Cognitive Assessment (MoCA) at 24 weeks compared with baseline
Time frame: 24 weeks (first stage)
Changes of Mini-Mental State Examination (MMSE) at 24 weeks compared with baseline
Time frame: 24 weeks (first stage)
Changes of Neuropsychiatric Inventory Questionnaire (NPI-Q) at 24 weeks compared with baseline
Time frame: 24 weeks (first stage)
Changes of Hamilton Anxiety Scale (HAMA) at 24 weeks compared with baseline
Time frame: 24 weeks (first stage)
Changes of Hamilton Depression Scale (HAMD) at 24 weeks compared with baseline
Time frame: 24 weeks (first stage)
Changes of 23-item version of Alzheimer's Disease Cooperative Study- activities of daily living scale (ADCS-ADL23) for activities of daily living at 24 weeks compared with baseline
Time frame: 24 weeks (first stage)
Changes of Clinical Dementia Rating (CDR) at 24 weeks compared with baseline
Time frame: 24 weeks (first stage)
Changes of infarct volume by cranial magnetic resonance imaging (MRI) at 24 weeks after treatment with butylphthalein compared with routine stroke treatment.
Time frame: 24 weeks (first stage)
Changes of infarct location by cranial magnetic resonance imaging (MRI) at 24 weeks after treatment with butylphthalein compared with routine stroke treatment.
Time frame: 24 weeks (first stage)
stroke recurrence
Time frame: 24 weeks (first stage)
Changes of modified Rankin Scale score (mRS) at 24 weeks compared with baseline.
Time frame: 24 weeks (first stage)
Changes of Montreal Cognitive Assessment (MoCA) at 48 weeks compared with baseline
Time frame: 48 weeks (second stage)
Changes of Mini-Mental State Examination (MMSE) at 48 weeks compared with baseline
Time frame: 48 weeks (second stage)
Changes cognitive domain level by Symbol Digit Modalities Test at 48 weeks compared with baselinel
Time frame: 48 weeks (second stage)
Changes cognitive domain level by Trail Making Test at 48 weeks compared with baseline.
Time frame: 48 weeks (second stage)
Changes of Neuropsychiatric Inventory Questionnaire (NPI-Q) at 48 weeks compared with baseline
Time frame: 48 weeks (second stage)
Changes of Hamilton Anxiety Scale (HAMA) at 48 weeks compared with baseline
Time frame: 48 weeks (second stage)
Changes of Hamilton Depression Scale (HAMD) at 48 weeks compared with baseline
Time frame: 48 weeks (second stage)
Changes of Clinical Dementia Rating (CDR) at 48 weeks compared with baseline
Time frame: 48 weeks (second stage)
Changes of 23-item version of Alzheimer's Disease Cooperative Study- activities of daily living scale (ADCS-ADL23) for activities of daily living at 48 weeks compared with baseline
Time frame: 48 weeks (second stage)
stroke recurrence
Time frame: 48 weeks (second stage)
Changes of mRS at 48 weeks compared with baseline.
Time frame: 48 weeks (second stage)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dl-3-butylphthalide in people with Stroke and Post-stroke Cognitive Impairment (PSCI), run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Dong (+8602152887145, dong_qiang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSCI incidence (time frame: 24 weeks (first stage)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.