Vascular Cognitive Impairment no DementiaPhase 2/3EBSCPVCINDNCT02993367
The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND
A Phase 2/3 study testing Butylphthalide Soft Capsules in people with Vascular Cognitive Impairment no Dementia, run by The Second Hospital of Hebei Medical University at 1 site in China.
Trial summary
Vascular cognitive impairment no dementia (VCIND) is very common among the aged and tends to progress to dementia, but there have been no proper large-scale intervention trials dedicated to it. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Vascular Cognitive Impairment no Dementia
- What is being tested?
- Butylphthalide Soft Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Jul 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Literate Han Chinese aged from 40 to 65 years
- MMSE ≥24
- Normal or slightly impaired activities of daily living
- The MRI entry criteria are as follows:
- Subcortical small infarcts (3-20 mm in diameter),or one or more strategically located subcortical small infarcts in the caudate nucleus globus pallidus, or thalamus
- Absence of cortical and watershed infarcts, hemorrhages, hydrocephalus, and WMLs with specific causes (e.g., multiple sclerosis); and
- No hippocampal or entorhinal cortex atrophy (scored 0 according to medial temporal lobe atrophy scale of Scheltens)
Who cannot join
- Patients with Diabetes mellitus
- Disorders other than subcortical VCIND that may affect cognition; the score of Hamilton depression scale more than 17 or schizophrenia
- Clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular system disease; cancer; alcoholism; drug addiction; use of medications that may affect cognitive functioning
- Known hypersensitivity to celery
- Inability to undergo a brain MRI
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Hebei medical university
Shijiazhuang, Hebei, 050000
zhu yifei, master, +8613303046666, 13831155688@163.com
liang panpan, master, +8617717711528, 674691785@qq.com
About this study
Official title: The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND:A Randomized, Double-blind,and Neuroimaging Study
Vascular cognitive impairment no dementia (VCIND) is very common among the aged and tends to progress to dementia, but there have been no proper large-scale intervention trials dedicated to it. VCIND caused by subcortical ischemic small vessel disease (hereinafter, subcortical VCIND) represents a relatively homogeneous disease process and is a suitable target for therapeutic trials investigating VCIND. Preclinical trials showed that Butylphthalide Soft Capsules is effective for cognitive impairment of vascular origin. In this randomized, double-blind, placebo-controlled trial, the investigators apply fMRI study the effects of Butylphthalide Soft Capsules in patients with VCIND.
- Being tested
- Butylphthalide Soft Capsules, Placebo Butylphthalide Soft Capsules
- Keywords
- Butylphthalide Soft Capsules, VCIND, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butylphthalide Soft CapsulesDrug
DL-3-n-butylphthalide (NBP) (Fig. 1) is a synthetic chiral compound containing L- and D-isomers of butylphthalide.Butylphthalide Soft Capsules is the oral preparation.
Placebo Butylphthalide Soft CapsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| the Butylphthalide Soft Capsules group | Experimental | 600mg Butylphthalide Soft Capsules/day,po tid,period of 6 months Receives: Drug: Butylphthalide Soft Capsules |
| the placebo group | Placebo comparator | 60mg Butylphthalide Soft Capsules/day,po tid,period of 6 months Receives: Drug: Placebo Butylphthalide Soft Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Cognitive function
Measured: Time points 0, 1, 3 and 6 months
Secondary outcomes (1)
change of brain function
Measured: Time point at 0, 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Cognitive Impairment no DementiaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yifei Zhu, The Second Hospital of Hebei Medical University
- Investigators
- Yifei Zhu, M.D., Principal investigator, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993367
- Sponsor's protocol ID
- ZYF55688
- Acronym
- EBSCPVCIND
- Status last verified
- Mar 2017
- First submitted
- 8 Dec 2016
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jia J, Wei C, Liang J, Zhou A, Zuo X, Song H, Wu L, Chen X, Chen S, Zhang J, Wu J, Wang K, Chu L, Peng D, Lv P, Guo H, Niu X, Chen Y, Dong W, Han X, Fang B, Peng M, Li D, Jia Q, Huang L. The effects of DL-3-n-butylphthalide in patients with vascular cognitive impairment without dementia caused by subcortical ischemic small vessel disease: A multicentre, randomized, double-blind, placebo-controlled trial. Alzheimers Dement. 2016 Feb;12(2):89-99. doi: 10.1016/j.jalz.2015.04.010. Epub 2015 Jun 15.
PubMed 26086183
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND:A Randomized, Double-blind,and Neuroimaging Study
- ClinicalTrials.gov ID
- NCT02993367
- Acronym / sponsor ID
- EBSCPVCIND / ZYF55688
- Keywords
- Butylphthalide Soft Capsules, VCIND, fMRI
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Second Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 15 Dec 2016 (estimated)
- 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.
Vascular cognitive impairment no dementia (VCIND) is very common among the aged and tends to progress to dementia, but there have been no proper large-scale intervention trials dedicated to it. VCIND caused by subcortical ischemic small vessel disease (hereinafter, subcortical VCIND) represents a relatively homogeneous disease process and is a suitable target for therapeutic trials investigating VCIND. Preclinical trials showed that Butylphthalide Soft Capsules is effective for cognitive impairment of vascular origin. In this randomized, double-blind, placebo-controlled trial, the investigators apply fMRI study the effects of Butylphthalide Soft Capsules in patients with VCIND.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the Butylphthalide Soft Capsules group | Experimental | Drug: Butylphthalide Soft Capsules600mg Butylphthalide Soft Capsules/day,po tid,period of 6 months |
| the placebo group | Placebo comparator | Drug: Placebo Butylphthalide Soft Capsules60mg Butylphthalide Soft Capsules/day,po tid,period of 6 months |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Literate Han Chinese aged from 40 to 65 years
- MMSE ≥24
- Normal or slightly impaired activities of daily living
- The MRI entry criteria are as follows:
Key exclusion criteria (5 listed)
- Patients with Diabetes mellitus
- Disorders other than subcortical VCIND that may affect cognition; the score of Hamilton depression scale more than 17 or schizophrenia
- Clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular system disease; cancer; alcoholism; drug addiction; use of medications that may affect cognitive functioning
- Known hypersensitivity to celery
- Inability to undergo a brain MRI
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 CapsulesDL-3-n-butylphthalide (NBP) (Fig. 1) is a synthetic chiral compound containing L- and D-isomers of butylphthalide.Butylphthalide Soft Capsules is the oral preparation. | Drug | the Butylphthalide Soft Capsules group |
| Placebo Butylphthalide Soft Capsules | Drug | the placebo group |
Primary outcome
change of Cognitive function
Time frame: Time points 0, 1, 3 and 6 months
1 secondary outcome
change of brain function
Time frame: Time point at 0, 1, 3, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Results publication: PubMed 26086183Jia J, Wei C, Liang J, Zhou A, Zuo X, Song H, Wu L, Chen X, Chen S, Zhang J, Wu J, Wang K, Chu L, Peng D, Lv P, Guo H, Niu X, Chen Y, Dong W, Han X, Fang B, Peng M, Li D, Jia Q, Huang L. The effects of DL-3-n-butylphthalide in patients with vascular cognitive impairment without dementia caused by subcortical ischemic small vessel disease: A multicentre, randomized, double-blind, placebo-controlled trial. Alzheimers Dement. 2016 Feb;12(2):89-99. doi: 10.1016/j.jalz.2015.04.010. Epub 2015 Jun 15.
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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.
Yifei Zhu, M.D. principal investigator
The Second Hospital of Hebei 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 2/3 study testing Butylphthalide Soft Capsules in people with Vascular Cognitive Impairment no Dementia, run by The Second Hospital of Hebei 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Mar 2017. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yifei Zhu, M.D. (+8613303046666, 13831155688@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of Cognitive function (time frame: Time points 0, 1, 3 and 6 months). 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 NCT02993367, which also lists 1 linked publication.
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 16 Mar 2017.