NCT02993367

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

March 16, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

December 8, 2016

Last Update Submit

March 15, 2017

Conditions

Vascular Cognitive Impairment no Dementia

Keywords

Butylphthalide Soft CapsulesVCINDfMRI

Outcome Measures

Primary Outcomes (1)

  • change of Cognitive function

    Time points 0, 1, 3 and 6 months

Secondary Outcomes (1)

  • change of brain function

    Time point at 0, 1, 3, 6 months

Study Arms (2)

the Butylphthalide Soft Capsules group

EXPERIMENTAL

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

Drug: Butylphthalide Soft Capsules

the placebo group

PLACEBO COMPARATOR

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

Drug: Placebo Butylphthalide Soft Capsules

Interventions

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.

the Butylphthalide Soft Capsules group
Placebo Butylphthalide Soft CapsulesDRUG
the placebo group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Hebei medical university

Shijiazhuang, Hebei, 050000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26086183RESULT

Study Officials

  • Yifei Zhu, M.D.

    The Second Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifei Zhu, M.D.

CONTACT

+861330304666613831155688@163.com

Panpan Liang, M.D.

CONTACT

+86177177115282354672781@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 8, 2016

First Posted

December 15, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

July 1, 2019

Last Updated

March 16, 2017

Record last verified: 2017-03

Locations

CN(1)