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Be-CLEVER

RecruitingPhase 3

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

Lead sponsor

Fudan University

Asset

dl-3-butylphthalide

Listed sites

Recruiting sites

Enrollment

3,200

estimated

Study population

Vascular cognitive impairment / dementia

Key I/E criteria

•Age ≥60•MRI contraindications excluded

Primary endpoints

•PSCI incidence•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDBe-CLEVER

NCT IDNCT05976152

Timeline

Milestones

Study first posted2023-08-04actual

Study start2024-04estimated (month precision)

Last update posted2024-04-15actual

Primary completion2026-12estimated (month precision)

Study completion2026-12estimated (month precision)

Assets

Drug assets

dl-3-butylphthalide

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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

Exclusion criteria

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

•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

Endpoints (26)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Behavior / neuropsychiatric

Other (unclassified)

Executive function / language

Function / daily living

Neuroimaging

Safety / tolerability / PK

Global cognition

6 endpoints

Secondary/protocol endpoint

Changes of Montreal Cognitive Assessment (MoCA) at 24 weeks compared with baseline

Time frame:24 weeks (first stage)

Montreal Cognitive Assessment (MoCA)

descriptive

Secondary/protocol endpoint

Changes of Mini-Mental State Examination (MMSE) at 24 weeks compared with baseline

Time frame:24 weeks (first stage)

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Changes of Clinical Dementia Rating (CDR) at 24 weeks compared with baseline

Time frame:24 weeks (first stage)

descriptive

Secondary/protocol endpoint

Changes of Montreal Cognitive Assessment (MoCA) at 48 weeks compared with baseline

Time frame:48 weeks (second stage)

Montreal Cognitive Assessment (MoCA)

descriptive

Secondary/protocol endpoint

Changes of Mini-Mental State Examination (MMSE) at 48 weeks compared with baseline

Time frame:48 weeks (second stage)

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Changes of Clinical Dementia Rating (CDR) at 48 weeks compared with baseline

Time frame:48 weeks (second stage)

descriptive

Executive function / language

3 endpoints

Secondary/protocol endpoint

Changes of modified Rankin Scale score (mRS) at 24 weeks compared with baseline.

Time frame:24 weeks (first stage)

descriptive

Secondary/protocol endpoint

Changes cognitive domain level by Trail Making Test at 48 weeks compared with baseline.

Time frame:48 weeks (second stage)

descriptive

Secondary/protocol endpoint

Changes of mRS at 48 weeks compared with baseline.

Time frame:48 weeks (second stage)

descriptive

Function / daily living

2 endpoints

Secondary/protocol endpoint

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)

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Secondary/protocol endpoint

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)

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

6 endpoints

Secondary/protocol endpoint

Changes of Neuropsychiatric Inventory Questionnaire (NPI-Q) at 24 weeks compared with baseline

Time frame:24 weeks (first stage)

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Changes of Hamilton Anxiety Scale (HAMA) at 24 weeks compared with baseline

Time frame:24 weeks (first stage)

descriptive

Secondary/protocol endpoint

Changes of Hamilton Depression Scale (HAMD) at 24 weeks compared with baseline

Time frame:24 weeks (first stage)

descriptive

Secondary/protocol endpoint

Changes of Neuropsychiatric Inventory Questionnaire (NPI-Q) at 48 weeks compared with baseline

Time frame:48 weeks (second stage)

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Changes of Hamilton Anxiety Scale (HAMA) at 48 weeks compared with baseline

Time frame:48 weeks (second stage)

descriptive

Secondary/protocol endpoint

Changes of Hamilton Depression Scale (HAMD) at 48 weeks compared with baseline

Time frame:48 weeks (second stage)

descriptive

Neuroimaging

2 endpoints

Secondary/protocol endpoint

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)

descriptive

Secondary/protocol endpoint

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)

descriptive

Safety / tolerability / PK

2 endpoints

Other/protocol endpoint

Incidence of Treatment-Emergent Adverse Events [Safety]

Time frame:12 weeks, 24 weeks, 36 weeks and 48 weeks

event count, event

Other/protocol endpoint

Dropout rates and reasons [Safety]

Time frame:12 weeks, 24 weeks, 36 weeks and 48 weekss

descriptive

Other (unclassified)

5 endpoints

Primary/protocol endpoint/low confidence

PSCI incidence

Time frame:24 weeks (first stage)

event count, event

Primary/protocol endpoint/low confidence

vadas-cog score

Time frame:6 months (Second stage)

ADAS-Cog

descriptive

Secondary/protocol endpoint/low confidence

stroke recurrence

Time frame:24 weeks (first stage)

descriptive

Secondary/protocol endpoint/low confidence

Changes cognitive domain level by Symbol Digit Modalities Test at 48 weeks compared with baselinel

Time frame:48 weeks (second stage)

descriptive

Secondary/protocol endpoint/low confidence

stroke recurrence

Time frame:48 weeks (second stage)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.