Overview

The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND

Status:
Unknown status
Trial end date:
2019-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Second Hospital of Hebei Medical University
Treatments:
3-n-butylphthalide
Criteria
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