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

Hebei Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Vascular Cognitive Impairment no Dementia

Treatments: Drug: Placebo Butylphthalide Soft Capsules; Drug: Butylphthalide Soft Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT02993367

ZYF55688

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

the Butylphthalide Soft Capsules group

Experimental group

Description:

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

Treatment:

Drug: Butylphthalide Soft Capsules

the placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Butylphthalide Soft Capsules