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The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND (EBSCPVCIND)

Primary Purpose

Vascular Cognitive Impairment no Dementia

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Butylphthalide Soft Capsules
Placebo Butylphthalide Soft Capsules
Sponsored by
The Second Hospital of Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Cognitive Impairment no Dementia focused on measuring Butylphthalide Soft Capsules, VCIND, fMRI

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Second Affiliated Hospital of Hebei medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

the Butylphthalide Soft Capsules group

the placebo group

Arm Description

600mg Butylphthalide Soft Capsules/day,po tid,period of 6 months

60mg Butylphthalide Soft Capsules/day,po tid,period of 6 months

Outcomes

Primary Outcome Measures

change of Cognitive function

Secondary Outcome Measures

change of brain function

Full Information

First Posted
December 8, 2016
Last Updated
March 15, 2017
Sponsor
The Second Hospital of Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02993367
Brief Title
The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND
Acronym
EBSCPVCIND
Official Title
The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND:A Randomized, Double-blind,and Neuroimaging Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Hospital of Hebei Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Cognitive Impairment no Dementia
Keywords
Butylphthalide Soft Capsules, VCIND, fMRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the Butylphthalide Soft Capsules group
Arm Type
Experimental
Arm Description
600mg Butylphthalide Soft Capsules/day,po tid,period of 6 months
Arm Title
the placebo group
Arm Type
Placebo Comparator
Arm Description
60mg Butylphthalide Soft Capsules/day,po tid,period of 6 months
Intervention Type
Drug
Intervention Name(s)
Butylphthalide Soft Capsules
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Butylphthalide Soft Capsules
Primary Outcome Measure Information:
Title
change of Cognitive function
Time Frame
Time points 0, 1, 3 and 6 months
Secondary Outcome Measure Information:
Title
change of brain function
Time Frame
Time point at 0, 1, 3, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yifei Zhu, M.D.
Phone
+8613303046666
Email
13831155688@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Panpan Liang, M.D.
Phone
+8617717711528
Email
2354672781@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yifei Zhu, M.D.
Organizational Affiliation
The Second Hospital of Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital of Hebei medical university
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhu yifei, master
Phone
+8613303046666
Email
13831155688@163.com
First Name & Middle Initial & Last Name & Degree
liang panpan, master
Phone
+8617717711528
Email
674691785@qq.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
26086183
Citation
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.
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The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND

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