Clinical trial NCT02993367: The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND
Official title: The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND:A Randomized, Double-blind,and Neuroimaging Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Vascular Cognitive Impairment no Dementia
Keywords: Butylphthalide Soft Capsules
VCIND
fMRI
Lead sponsor: The Second Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: change of Cognitive function
timeFrame: Time points 0, 1, 3 and 6 months
Secondary outcomes:
measure: change of brain function
timeFrame: Time point at 0, 1, 3, 6 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Second Affiliated Hospital of Hebei medical university
state: Hebei
Study officials:
affiliation: The Second Hospital of Hebei Medical University
name: Yifei Zhu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jia J, Wei C, Liang J, Zhou A, Zuo X, Song H, Wu L, Chen X, Chen S, Zhang J, Wu J, Wang K, Chu L, Peng D, Lv P, Guo H, Niu X, Chen Y, Dong W, Han X, Fang B, Peng M, Li D, Jia Q, Huang L. The effects of DL-3-n-butylphthalide in patients with vascular cognitive impairment without dementia caused by subcortical ischemic small vessel disease: A multicentre, randomized, double-blind, placebo-controlled trial. Alzheimers Dement. 2016 Feb;12(2):89-99. doi: 10.1016/j.jalz.2015.04.010. Epub 2015 Jun 15.