The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND

Study Overview
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Brief Summary
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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.

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

Conditions
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Vascular Cognitive Impairment no Dementia

Intervention / Treatment
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* Drug: Butylphthalide Soft Capsules
* Drug: Placebo Butylphthalide Soft Capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the Butylphthalide Soft Capsules group<br>600mg Butylphthalide Soft Capsules/day,po tid,period of 6 months | Drug: Butylphthalide Soft Capsules<br>* 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.<br>|
| Placebo Comparator: the placebo group<br>60mg Butylphthalide Soft Capsules/day,po tid,period of 6 months | Drug: Placebo Butylphthalide Soft Capsules<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Cognitive function |  | Time points 0, 1, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of brain function |  | Time point at 0, 1, 3, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VCIND, fMRI, Butylphthalide Soft Capsules