A Phase 4 interventional study of Cerebralcare pills and Cerebralcare pills placebo in Cerebral Small Vessel Diseases, sponsored by Beijing Tiantan Hospital. Status unknown at 1 site in China. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by Beijing Tiantan Hospital · Phase 4, Interventional, and Treatment
This is a randomized, double-blinded, placebo-controlled, multicenter trial. Cerebral small vessel disease (CSVD) patients will be diagnosed by Magnetic Resonance Imaging (MRI) and randomized into treatment or control groups. The purpose of this trial is to assess the efficacy of cerebralcare pills on cerebral small vessel disease.
Cerebral small vessel disease (CSVD) is prevalent in the aging population with insidious onset, almost affecting all levels of the brain vasculature, and challenges the social and healthcare system worldwide. CSVD is the major cause of 25% of strokes and more than doubles the odds of recurrent stroke; furthermore, it contributes to 45% of dementia cases and to global functional decline. However, an incomplete understanding of the pathogenesis of CSVD limits prevention and treatment efforts.
Cerebralcare Granule (CG) or Yangxue Qingnao granule, is a polyherbal medicine that was approved in 1997 by the China State Food and Drug Administration for the treatment of headaches and dizziness associated with cerebrovascular diseases. Cerebralcare pill is composed of 11 herbs. These herbs contain small molecules with various pharmacological actions. Cerebralcare pills have the same component as CG. Previous studies have demonstrated that CG significantly attenuated ischemia-reperfusion induced dysfunction, structural abnormalities in the microcirculation, and inflammatory injury. There are also studies confirming that CG also improved cognition function, improved cerebral microcirculation disorders, and hemodynamics.
Patients enrolled will be randomly assigned to either the treatment or control group to receive Brain Pill/Brain Pill placebo (from randomization to 6 months at a dose of 2 packs per day). Face-to-face interviews will be conducted at baseline, day 90, day 180, and 1 year after randomization.
The primary endpoint is the progression in cognition function which is assessed by Montreal Cognitive Assessment (MoCA) score. The secondary endpoints include changes in clinical characters, imaging markers (number and volume of white matter, number of lacunes, microbleeds, enlarged perivascular space ), hemodynamic parameters, Chinese medical symptoms, blood-brain barrier (BBB) permeability, proteomics, and inflammatory markers. The safety endpoints include severe hemorrhage events, symptomatic and asymptomatic intracranial hemorrhage, moderate hemorrhage, overall mortality, and serious adverse events.
126 studies on the registry are indexed under Cerebral Small Vessel Diseases; 69 are open to participants now.
This study's planned enrollment of 114 is above the median of 88 across 73 interventional studies indexed under Cerebral Small Vessel Diseases.
Browse Cerebral Small Vessel Diseases studies →Beijing Tiantan Hospital is the lead sponsor of 481 studies on the registry; 287 are open to participants now.
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This group will receive Cerebralcare pills placebo, 2 packages, twice a day, from the day of randomization to 6 months.
Drug: Cerebralcare pills placebo
This group will receive Cerebralcare pills, 2 packages, twice a day, from the day of randomization to 6 months.
Drug: Cerebralcare pills
a dose of 2 packages, twice a day of Cerebralcare pills
Cerebralcare pills placebo will be administrated at the same rate with experimental group
Progression in cognition function
Cognition function assessed by Montreal Cognitive Assessment (MoCA) score. Score range 0-30. Higher scores mean a better outcome..
Time frame: 6 months after randomization
Changes in both systolic and diastolic blood pressure
Including systolic and diastolic blood pressure (mmHg).
Time frame: 3 months, 6 months and 1 year after randomization
Rey auditory verbal learning test（RAVLT）
The Rey Auditory Verbal Learning Test (RAVLT) provides a standardized procedure to evaluate a range of aspects of verbal learning and memory of supra-span lists of words. The test requires recalling as many words as possible in any order from a standard list of 15 unrelated words read out by the examiner. The total score ranges from 0-120, with a lower score indicating a worse outcome.
Time frame: 3 months, 6 months and 1 year after randomization
Generalized Anxiety Disorder 7（GAD-7)
Generalized Anxiety disorder (GAD) is a widespread psychiatric syndrome involving significant consequences on people's health, with a total score of 21, where a higher score means a worse outcome. However, recent data show that this disorder has received little attention when compared to other anxiety disorders.
Time frame: 3 months, 6 months and 1 year after randomization
Self-rating depression scale
The Zung Self-Rating Depression Scale (SDS) consists of 20 items with a Likert type scale after each item. Each item is rated from 1 to 4, with scores ranging from 20 to 80, where higher scores mean worse results
Time frame: 3 months, 6 months and 1 year after randomization
Dizziness handicap inventory（DHI）
The DHI has 25 items with 3 response levels, sub-grouped into three domains: functional, emotional, and physical. A shortened version, the Dizziness Handicap Inventory short form (DHIsf), reduced to 13 items with 2 response levels, has been shown to compare favourably to the original version. Scores range from 0-100, with higher scores indicating worse outcomes.
Time frame: 3 months, 6 months and 1 year after randomization
Headache impact test 6(HIT-6）
The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress.Total HIT-6 score that ranges from 36 to 78, where a lower score indicates a greater impact of headache on the daily life of the respondent.
Time frame: 3 months, 6 months and 1 year after randomization
EuroQol five dimensions questionnaire (EQ-5D)
It includes a descriptive system(DS) and a visual analogue scale(VAS). Two indicators are index value(ranged 0-1) and visual score(ranged 0-100) with higher scores corresponding to better health status.
Time frame: 3 months, 6 months and 1 year after randomization
Stroop Color Word Test
The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. Shorter the test time, the better the outcome.
Time frame: 3 months, 6 months and 1 year after randomization
Severity of white matter hyperintensities(WMHs)
Fazekas score is used to describe the different types of hyperintense signal abnormalities surrounding the ventricles and in the deep white matter. Periventricular hyperintensity (PVH) is graded as 0 = absence, 1 = "caps" or pencil-thin lining, 2 = smooth "halo", 3 = irregular PVH extending into the deep white matter. Separate deep white matter hyperintensity (DWMH) is rated as 0 = absence, 1 = punctate foci, 2 = beginning confluence of foci, 3 = large confluent areas. Higher scores indicats a worse outcome.
Time frame: 6 months and 1 year after randomization
Changes of white matter hyperintensities(WMHs) volume
WMH volume is assessed on 3D fluid attenuated inversion recovery (FLAIR) sequence in mm3 or cm3. Larger volume indicates a worse outcome.
Time frame: 6 months and 1 year after randomization
Number of lacunes
Lacunes were defined as rounded or ovoid lesions in the subcortical, basal ganglia, or brainstem, ranging from 3mm to 20mm in diameter, presenting with cerebral spinal fluid signal intensity on T2 and FLAIR, generally featuring a hyperintense rim on FLAIR and no increased signal on diffusion weighted imaging (DWI). Higher number of lacunae means a worse outcome.
Time frame: 6 months and 1 year after randomization
Number of cerebral microbleeds
Cerebral microbleeds are defined as rounded, hypodense foci within brain parenchyma on susceptibi lity weighted imaging (SWI) sequence, up to 10 mm in diameter, and were differentiated from microbleed mimics based on current guidelines. Higher number of cerebral microbleeds means a worse outcome.
Time frame: 6 months and 1 year after randomization
Number of enlarged perivascular space
Enlarged perivascular space was defined as small punctate or linear hyperintensities on T2 images in the basal ganglia or centrum semiovale. Higher number of enlarged perivascular spaces means a worse outcome.
Time frame: 6 months and 1 year after randomization
Changes in hemodynamic parameters
Lower cerebrovascular reactivity (CVR), cerebral blood flow (CBF), and reduced radial peripapillary capillary network density, and parafoveal vessel densities of the superficial retinal capillary plexuses mean worse outcomes.
Time frame: 6 months and 1 year after randomization
changes in Chinese medical symptoms
Chinese medical symptoms assessed by Blood Deficiency and Liver Hyperactivity Syndrome score. Scores range 0-21 and higher scores mean a worse outcome.
Time frame: 6 months and 1 year after randomization
Difference of recurrent stroke between groups
stroke included ischemic stroke, hemorrhagic stroke, TIA, et al.
Time frame: 3 months, 6 months and 1 year after randomization
changes in Blood-Brain Barrier (BBB) Permeability between groups
BBB permeability is assessed by MRI and biomarker (including NSE, GFAP, S100β).
Time frame: 6 months and 1 year after randomization
Compare protein profiles observed among different groups.
Blood was collected from the healthy (n=6), experimental (n=6) and placebo (n=6) groups at baseline, 3 months, and 12 months post-dosing. Alterations in protein profiles were detected by high performance liquid chromatography-mass spectrometry (HPLC-MS). GO classification and pathway enrichment were performed to analyse relevant protein changes. Serum metabolomics was determined using untargeted assays, and metabolite patterns in different groups were distinguished using orthogonal partial least squares analysis (OPLS-DA), compared with databases, and validated with the help of standards to finalise qualitative and quantitative analysis of metabolites and to identify differential metabolites. The Cell Counting Bead Analysis (CBA) Flex Set Flow Multifactor Assay Kit is used to detect serum levels of the inflammatory factors IL-1β, IL-6, IL-10, IL-12 and TNF-α. Western blot analysis is used to validate changes in the expression of 20 key proteins obtained from proteomic analysis.
Time frame: 6 months and 1 year after randomization
Composite vascular events
Incidence of symptomatic stroke, myocardial infarction and vascular death.
Time frame: 3 months, 6 months and 1 year after randomization
All-cause death
Deaths from all causes to the research subjects
Time frame: 3 months, 6 months and 1 year after randomization
Moderate and/or severe hemorrhage events
According to Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) criteria which classifies the severity of bleeding complications as follows: 1) severe or life-threatening bleeding-intracranial bleeding or bleeding that causes substantial hemodynamic compromise requiring treatment; 2) moderate bleeding-bleeding which needs blood transfusion; 3) minor bleeding-other bleeding, neither requiring transfusion nor causing hemodynamic compromise.
Time frame: 3 months, 6 months and 1 year after randomization
Symptomatic and/or asymptomatic intracranial hemorrhage
Time frame: 3 months, 6 months and 1 year after randomization
Adverse events and severe adverse events
renal failure, hepatic failure, death.
Time frame: 3 months, 6 months and 1 year after randomization
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