Vascular DementiaPhase 3NCT03804229

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

A Phase 3 study testing Butylphthalide soft capsule in people with Vascular Dementia, run by Capital Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 50 to 75 years
Conditions the study is for: Vascular Dementia
What is being tested?: Butylphthalide soft capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 707 participants
Where: 1 siteChina
Study dates: 29 Oct 2019to 7 Jun 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 50 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053

Other trials in China

About this study

Official title: 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

Butylphthalide soft capsule has been confirmed to have beneficial effects for patients with vascular dementia (VaD) in clinical trial of phase II study. So the investigators hypothesize that Butylphthalide soft capsule may have same beneficial effects for patients with VaD in an extended samples in phase III study. In present study the investigators will recruit patients with mild to moderate VaD in a multi-center, random, double blind and placebo control methods to confirm the efficacy and safety of Butylphthalide soft capsule. The outcome measures include general cognitive function, executive function, daily living skills, and mental behavior changes of symptoms in VaD patients.

Read the detailed description

Butylphthalide soft capsule is a synthetic chiral compound containing L- and D-isomers of butylphthalide. Studies in the past several decades have demonstrated that it could alleviate the learning and memory deficits induced by cerebral ischemia in rats. The phase II study enrolled 281 patients showed greater effects than placebo on ADAS-cog and CIBIC-plus. Butylphthalide soft capsule were uncommon and primarily consisted of mild gastrointestinal symptoms. In the present phase III study the investigators will re-assess the efficacy and the safety of Butylphthalide soft capsule for the treatment of mild to moderate vascular dementia in 700 subjects.

Conditions: Vascular Dementia
Being tested: Butylphthalide soft capsule, Placebo soft capsule
Keywords: Vascular Dementia, cognition
Medical subject headings: Dementia, Vascular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Butylphthalide soft capsuleDrug
Also called The effects of Butylphthalide soft capsule on VaD
700 subjects are randomly divided into two groups by 1:1. About 350 patients in the active group take two pills(100mg each) of Butylphthalide soft capsule each time, three times a day, 0.5 hours before meal, taking with lukewarm water.
Placebo soft capsuleDrug
Also called Placebo
700 subjects are randomly divided into two groups by 1:1. About 350 patients in the active group take two pills of placebo soft capsule each time, three times a day, 0.5 hours before meal, taking with lukewarm water.

Study groups in NCT03804229
Study group	Role	What they receive
active group	Experimental	Take two pills (100 mg each) of Butylphthalide soft capsule each time, three times a day, 0.5 hours before meal, taking with lukewarm water. Receives: Drug: Butylphthalide soft capsule
control group	Placebo comparator	Take two pills of placebo soft capsule each time, three times a day, 0.5 hours before meal, taking with lukewarm water. Receives: Drug: Placebo soft capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog)
The group difference between the treatment group and the control group in the difference between the Vascular AD Assessment Scale Cognitive Subscale (VaDAS-cog) score at weeks 13, 26, 39 and 52 and the baseline score. The 6 areas of the cognitive function assessed by VaDAS-cog include the memory, the language competence, the orientation, the inferential capability, the practical ability and the comprehension. The total score is from 0 to 90 and the lower the score the milder the disease.
Measured: Change from baseline VaDAS-cog score at Week 52

Secondary outcomes (8)

Clinician Interview Based Impression of Severity (CIBIC-plus)
The group difference between the treatment group and the control group in the difference between the Clinician Interview Based Impression of Severity (CIBIC-plus) score at weeks 13, 26, 39 and 52 and the baseline score. CIBIC-plus is a kind of scale that is assessed based on the clinical changes of the patient according to the impression obtained through interviewing the patient and other insiders. The score is from 1 to 7. And 1 indicates that the recovery is optimal, 4 indicates that there is no change and 7 indicates overall worsening.
Measured: Change from baseline CIBIC-plus score at Week 52
Alzheimer's Disease Co-operative Study Activities of Daily Living (ADCS-ADL)
The group difference in the difference between the Alzheimer's Disease Co-operative Study Activities of Daily Living (ADCS-ADL) scores at weeks 13 (±7 days), week 26 (±7 days) , week 39 (±7 days) and week 52 (±7 days) and the base line score.
Measured: Change from baseline ADCS-ADL score at Week 52
Neuropsychiatric Inventory (NPI)
It evaluates both the presence and severity of 12 neuropsychiatric features. The caregiver is asked to rate the frequency of the symptoms of that domain on a scale of 1 to 4 (1 = occasionally, less than once per week; 4 = very frequently, once or more per day or continuously) as well as their severity (1 = mild, 2 = moderate, 3 = severe). The total score for each domain is calculated by multiplying the frequency by the severity. A total score is calculated by adding all the domain scores together. Caregiver distress is rated by the caregiver on a six-point scale from 0 (no distress) to 5 (very severe or extreme distress). The total score of the caregiver's distress is obtained separately. The total NPI score is from 0 to 144 and the lower the score the milder the disease, the total caregiver distress score is from 0 to 6. The group difference between the NPI scores at weeks 13 (±7 days), week 26 (±7 days), week 39 (±7 days) and week 52 (±7 days) and the base line score.
Measured: Change from baseline NPI score at Week 52
Mini-mental State Examination (MMSE)
The group difference in the difference between the Mini-mental State Examination (MMSE) scores at weeks 13 (±7 days), week 26 (±7 days), week 39 (±7 days) and week 52 (±7 days) and the baseline score.
Measured: Change from baseline MMSE score at Week 52
MRI
The changes before and after the treatment at the cranial MRI bilateral hippocampus, the gyrus cinguli, the posterior horn of lateral ventricle, the infarction and the frontal temporal lobe white matter volume before the treatment, and at weeks 26 (± 7days) and 52 (±7days).
Measured: Change from baseline MRI at Week 52
Blood biomarker
The concentration of BDNF and VEGF measured before the treatment, and at weeks 26 (± 7days) and 52 (±7 days) respectively.
Measured: Change from baseline concentration of BDNF and VEGF at Week 52
MI/Cr ratio
The myoinositol (MI) and the creatine (Cr) levels (obtain the MI/Cr ratio) measured before the treatment, and at weeks 26 and 52 respectively.
Measured: Change from baseline MI/Cr ratio at Week 52
Acetyl choline level
The concentration of acetyl choline in the blood measured before the treatment, and at weeks 26 (± 7days) and 52 (± 7days) respectively.
Measured: Change from baseline concentration of acetyl choline at Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 20197 Jun 2026

First posted15 Jan 2019
Study start29 Oct 2019
Primary completion23 Oct 2024
Study completion7 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Vascular DementiaStudies of the same condition, open and under way.
More trials run by Capital Medical 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: 707 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03804229
Sponsor's protocol ID: CSPC-NBP-2018102
Status last verified: Mar 2026
First submitted: 11 Jan 2019
Last updated: 23 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vascular Dementia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03804229
Acronym / sponsor ID: CSPC-NBP-2018102
Conditions: Vascular Dementia
Keywords: Vascular Dementia, cognition
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 707 participants (actual)
Lead sponsor: Capital Medical UniversityUniversity, hospital or other
Collaborators: CSPC-NBP Pharmaceutical Co., Ltd.
Study start: 29 Oct 2019 (actual)
Primary completion: 23 Oct 2024 (actual)
Study completion: 7 Jun 2026 (estimated)
First posted: 15 Jan 2019 (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.

Detailed description

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
active group	Experimental	Drug: Butylphthalide soft capsuleTake two pills (100 mg each) of Butylphthalide soft capsule each time, three times a day, 0.5 hours before meal, taking with lukewarm water.
control group	Placebo comparator	Drug: Placebo soft capsuleTake two pills of placebo soft capsule each time, three times a day, 0.5 hours before meal, taking with lukewarm water.

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (16 listed)

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.

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
Butylphthalide soft capsuleAlso: The effects of Butylphthalide soft capsule on VaD700 subjects are randomly divided into two groups by 1:1. About 350 patients in the active group take two pills(100mg each) of Butylphthalide soft capsule each time, three times a day, 0.5 hours before meal, taking with lukewarm water.	Drug	active group
Placebo soft capsuleAlso: Placebo700 subjects are randomly divided into two groups by 1:1. About 350 patients in the active group take two pills of placebo soft capsule each time, three times a day, 0.5 hours before meal, taking with lukewarm water.	Drug	control group

Primary outcome

Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog)
Time frame: Change from baseline VaDAS-cog score at Week 52
The group difference between the treatment group and the control group in the difference between the Vascular AD Assessment Scale Cognitive Subscale (VaDAS-cog) score at weeks 13, 26, 39 and 52 and the baseline score. The 6 areas of the cognitive function assessed by VaDAS-cog include the memory, the language competence, the orientation, the inferential capability, the practical ability and the comprehension. The total score is from 0 to 90 and the lower the score the milder the disease.

8 secondary outcomes

Clinician Interview Based Impression of Severity (CIBIC-plus)
Time frame: Change from baseline CIBIC-plus score at Week 52
Alzheimer's Disease Co-operative Study Activities of Daily Living (ADCS-ADL)
Time frame: Change from baseline ADCS-ADL score at Week 52
Neuropsychiatric Inventory (NPI)
Time frame: Change from baseline NPI score at Week 52
Mini-mental State Examination (MMSE)
Time frame: Change from baseline MMSE score at Week 52
MRI
Time frame: Change from baseline MRI at Week 52
Blood biomarker
Time frame: Change from baseline concentration of BDNF and VEGF at Week 52
MI/Cr ratio
Time frame: Change from baseline MI/Cr ratio at Week 52
Acetyl choline level
Time frame: Change from baseline concentration of acetyl choline at Week 52

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 23 Mar 2026.

Related trials for Vascular Dementia

Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
RecruitingObservational study
China HEalthy Aging and Dementia Study (HEAD)
Alzheimer Disease (AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Registry for CADASIL
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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. This study is not recruiting at the moment.

Jianping Jia, MD,PhD principal investigator

Xuanwu Hospital of Capital Medical University

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 Butylphthalide soft capsule in people with Vascular Dementia, run by Capital Medical 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 16 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: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog) (time frame: Change from baseline VaDAS-cog score at Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03804229.

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 23 Mar 2026.