The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND

Vascular Cognitive Impairment no Dementia Clinical Trial

— EBSCPVCIND  

Official title:

The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND:A Randomized, Double-blind,and Neuroimaging Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02993367
• Other study ID #: ZYF55688
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 8, 2016
• Last updated: March 15, 2017
• Start date: January 2017
• Est. completion date: July 2019

Study information

• Verified date: March 2017
• Source: The Second Hospital of Hebei Medical University
• Contact: Yifei Zhu, M.D.
• Phone: +8613303046666
• Email: 13831155688[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Dementia
• Vascular Cognitive Impairment no Dementia

Intervention

Drug:
• Butylphthalide Soft Capsules
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 Capsules

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Hebei medical university	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

References & 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 cogni — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of Cognitive function		Time points 0, 1, 3 and 6 months
Secondary	change of brain function		Time point at 0, 1, 3, 6 months