Active not recruitingPhase 3

Efficacy and Safety of Butylphthalide Soft Capsule for the Treatment of Vascular Dementia

A Multi-center, Random, Double Blind and Placebo Control Phase III Clinical Study on the Efficacy and Safety of Butylphthalide Soft Capsule for the Treatment of Vascular Dementia

Lead sponsor

Capital Medical University

Asset

Butylphthalide

Listed sites

Recruiting sites

Enrollment

707

actual

Study population

Vascular cognitive impairment / dementia

Key I/E criteria

•Vascular dementia•MMSE 20-26

Primary endpoint

•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 IDCSPC-NBP-2018102

NCT IDNCT03804229

Timeline

Milestones

Study first posted2019-01-15actual

Study start2019-10-29actual

Primary completion2024-10-23actual

Last update posted2026-03-23actual

Study completion2026-06-07estimated

Assets

Drug assets

Butylphthalide

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•1. Age ≥50 and ≤75, male or female.

•2. The subjects must have completed primary school education or above, and be able to complete the cognitive ability test and other tests required by the program.

•3. Meet the vascular dementia diagnosis criteria specified in the Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-V).

•4. Meet the SIVD diagnosis criteria of Erkinjuntti.

•5. MRI supports the existence of an ischemic cerebrovascular disease; Meet the National Institute of Neurological Disorders and Stroke (NINDS-AIREN) imaging diagnosis criteria; The lesion located between supra-tentorial and subcortical areas; The maximum diameter of the infarction ≤30mm; The number of infarctions ≥3, and/or Fazekas score=2-3.

•6. The patients need to be enrolled 3 months after the last stroke, if there is a clear history of stroke; otherwise meet other Criteria.

•7.The subjects are suffering from mild or moderate vascular dementia, with 11≤ MMSE ≤26, and the Clinical Dementia Rating (CDR) score 1≤ CDR ≤2.

•8. The Hamilton depression scale (HAMD) total score ≤17.

•9. The patient agrees to participate in this study and the patient or his or her legal guardian has signed the informed consent before the study.

•10. The subjects must have a care giver who has completed primary school education or above. The MMSE score of the care giver should be within the following range: education level of primary school > 20 points, education level above primary school > 24 points. And the care giver shall also be able to take care of the patient at least 4 days a week for more than 4 hours a day while he or she can accompany the subjects to attend each visit

Exclusion criteria

•1. Patients suffering from dementia caused by other cerebral diseases other than VaD (such as Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease, demyelinating diseases of the central nervous system, tumors, hydrocephalus, traumas, syphilis, AIDS, Creutzfeldt-Jakob disease, etc.);

•2. MRI indicates hippocampus or entorhinal cortex atrophy; and patients for whom VaD in combination with AD has been maximally excluded. But the following two cases can be included: ① Those aged 70 years and above with MTA score of grade 2 can be included; ② Those with grade 3 white matter injury score can be included with MTA score of grade 2.

•3. Patients with severe neurologic impairments that hinder them from completing the required tests, such as hemiplegia of the convenient hand, various kinds of aphasia, and audio or visual disorders.

•4. Patients who cannot swallow any orally administered drugs, or who is suffering from any disease that can affect the absorption of orally administered drugs, such as active intestinal diseases, partial or complete intestinal obstruction.

•5. Patients suffering from severe diseases of the circulation system, the respiration system, the urinary system, the digestive system and the hemopoietic system (such as unstable angina pectoris, uncontrollable asthma and active gastric bleeding) and cancer.

•6. Patients suffering from nutritional and metabolic diseases and endocrine system disorders, such as thyroid disease, parathyroid disease and deficiency of vitamin or other elements.

•7. Patients suffering from severe mental diseases (such as depression and schizophrenia) and epilepsy.

•8. Patients with alcohol or drug abuse.

•9. Patients with a family history of dementia.

•10. Patients who have been given any drug that can affect the cognitive function, such as cholinergic drugs, antipsychotic drugs and nootropic agents (including traditional Chinese herbal medicines and pills, such as cholinesterase inhibitors, memantine, Cenma Yizhi Capsules and Jiannaoan), for a long period of time (within 3 month before the start of this study and will continue using such drug).

•11. Patients who have used Butylphthalide soft capsule or injection within 2 weeks before grouping.

•12. Patients who are allergic to Butylphthalide/celery.

•13. Patients with severe bleeding tendency or hepatic dysfunction (with transaminase higher than 3 times of the normal upper limit).

•14. Pregnant or breast feeding women.

•15. Patients who have participated in other interference clinical studies within 3 months before grouping.

•16. Patients for whom MRI cranial imaging cannot be performed.

Endpoints (9)

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

Other (unclassified)

Function / daily living

Behavior / neuropsychiatric

Neuroimaging

Fluid / digital biomarkers

Other clinical outcomes

Global cognition

2 endpoints

Primary/protocol endpoint

Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog)

Time frame:Change from baseline VaDAS-cog score at Week 52

ADAS-Cog

descriptive

Secondary/protocol endpoint

Mini-mental State Examination (MMSE)

Time frame:Change from baseline MMSE score at Week 52

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Alzheimer's Disease Co-operative Study Activities of Daily Living (ADCS-ADL)

Time frame:Change from baseline ADCS-ADL score at Week 52

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:Change from baseline NPI score at Week 52

Neuropsychiatric Inventory (NPI)

event count, event

Neuroimaging

1 endpoint

Secondary/protocol endpoint

MRI

Time frame:Change from baseline MRI at Week 52

descriptive

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Blood biomarker

Time frame:Change from baseline concentration of BDNF and VEGF at Week 52

concentration, descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Clinician Interview Based Impression of Severity (CIBIC-plus)

Time frame:Change from baseline CIBIC-plus score at Week 52

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

MI/Cr ratio

Time frame:Change from baseline MI/Cr ratio at Week 52

ratio, descriptive

Secondary/protocol endpoint/low confidence

Acetyl choline level

Time frame:Change from baseline concentration of acetyl choline at Week 52

concentration, 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.