CerebrAlcare Pills on CereBral Small VesseL DiseasE（CABLE）
NCT05578521, Phase 4, Unknown, Beijing Tiantan Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | CerebrAlcare Pills on CereBral Small VesseL DiseasE（CABLE） | ClinicalTrials.gov |
| NCT number | NCT05578521 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 114 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beijing Tiantan Hospital | ClinicalTrials.gov |
| Conditions | Cerebral Small Vessel Diseases | ClinicalTrials.gov |
| Interventions | Cerebralcare pills, Cerebralcare pills placebo | ClinicalTrials.gov |
| First posted | 2022-10-13 | ClinicalTrials.gov |
| Last updated | 2022-10-13 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Progression in cognition function | 6 months after randomization | Cognition function assessed by Montreal Cognitive Assessment (MoCA) score. Score range 0-30. Higher scores mean a better outcome.. | ClinicalTrials.gov |
| Secondary | Changes in both systolic and diastolic blood pressure | 3 months, 6 months and 1 year after randomization | Including systolic and diastolic blood pressure (mmHg). | ClinicalTrials.gov |
| Secondary | Rey auditory verbal learning test（RAVLT） | 3 months, 6 months and 1 year after randomization | 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. | ClinicalTrials.gov |
| Secondary | Generalized Anxiety Disorder 7（GAD-7) | 3 months, 6 months and 1 year after randomization | 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. | ClinicalTrials.gov |
| Secondary | Self-rating depression scale | 3 months, 6 months and 1 year after randomization | 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 | ClinicalTrials.gov |
| Secondary | Dizziness handicap inventory（DHI） | 3 months, 6 months and 1 year after randomization | 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. | ClinicalTrials.gov |
| Secondary | Headache impact test 6(HIT-6） | 3 months, 6 months and 1 year after randomization | 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. | ClinicalTrials.gov |
| Secondary | EuroQol five dimensions questionnaire (EQ-5D) | 3 months, 6 months and 1 year after randomization | 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. | ClinicalTrials.gov |
| Secondary | Stroop Color Word Test | 3 months, 6 months and 1 year after randomization | 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. | ClinicalTrials.gov |
| Secondary | Severity of white matter hyperintensities(WMHs) | 6 months and 1 year after randomization | 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. | ClinicalTrials.gov |
| Secondary | Changes of white matter hyperintensities(WMHs) volume | 6 months and 1 year after randomization | WMH volume is assessed on 3D fluid attenuated inversion recovery (FLAIR) sequence in mm3 or cm3. Larger volume indicates a worse outcome. | ClinicalTrials.gov |
| Secondary | Number of lacunes | 6 months and 1 year after randomization | 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. | ClinicalTrials.gov |
| Secondary | Number of cerebral microbleeds | 6 months and 1 year after randomization | 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. | ClinicalTrials.gov |
| Secondary | Number of enlarged perivascular space | 6 months and 1 year after randomization | 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. | ClinicalTrials.gov |
| Secondary | Changes in hemodynamic parameters | 6 months and 1 year after randomization | 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. | ClinicalTrials.gov |
| Secondary | changes in Chinese medical symptoms | 6 months and 1 year after randomization | Chinese medical symptoms assessed by Blood Deficiency and Liver Hyperactivity Syndrome score. Scores range 0-21 and higher scores mean a worse outcome. | ClinicalTrials.gov |
| Secondary | Difference of recurrent stroke between groups | 3 months, 6 months and 1 year after randomization | stroke included ischemic stroke, hemorrhagic stroke, TIA, et al. | ClinicalTrials.gov |
| Secondary | changes in Blood-Brain Barrier (BBB) Permeability between groups | 6 months and 1 year after randomization | BBB permeability is assessed by MRI and biomarker (including NSE, GFAP, S100β). | ClinicalTrials.gov |
| Secondary | Compare protein profiles observed among different groups. | 6 months and 1 year after randomization | 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. | ClinicalTrials.gov |
| Secondary | Composite vascular events | 3 months, 6 months and 1 year after randomization | Incidence of symptomatic stroke, myocardial infarction and vascular death. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 40897453 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)