Vascular Cognitive Impairment no Dementia
Conditions
Keywords
Butylphthalide Soft Capsules, VCIND, fMRI
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.
Interventions
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.
DRUGPlacebo Butylphthalide Soft Capsules
Sponsors
The Second Hospital of Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of Cognitive function | Time points 0, 1, 3 and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| change of brain function | Time point at 0, 1, 3, 6 months |
Countries
China
Contacts
Primary ContactYifei Zhu, M.D.
Backup ContactPanpan Liang, M.D.
Outcome results
None listed