The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND

Phase 2

• Conditions: Vascular Cognitive Impairment no Dementia
• Interventions: Drug: Placebo Butylphthalide Soft Capsules; Drug: Butylphthalide Soft Capsules

• Registration Number: NCT02993367
• Lead Sponsor: The Second Hospital of Hebei Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-15
• Study Start: 2017-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-03-16
• Primary Completion: 2019-01
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the placebo group	Placebo Butylphthalide Soft Capsules	60mg Butylphthalide Soft Capsules/day,po tid,period of 6 months
the Butylphthalide Soft Capsules group	Butylphthalide Soft Capsules	600mg Butylphthalide Soft Capsules/day,po tid,period of 6 months

Primary Outcome Measures

Name	Time	Method
change of Cognitive function	Time points 0, 1, 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
change of brain function	Time point at 0, 1, 3, 6 months

Trial Locations

Locations (1)

Second Affiliated Hospital of Hebei medical university; 🇨🇳 Shijiazhuang, Hebei, China