Safety and Efficacy of Edaravone Dexborneol Sublingual Tablets for Blood-Brain Barrier Dysfunction in CADASIL
NCT07692399, Phase 2, Not yet recruiting, Huashan Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Safety and Efficacy of Edaravone Dexborneol Sublingual Tablets for Blood-Brain Barrier Dysfunction in CADASIL | ClinicalTrials.gov |
| NCT number | NCT07692399 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Huashan Hospital | ClinicalTrials.gov |
| Conditions | CADASIL | ClinicalTrials.gov |
| Interventions | Edaravone Dexborneol Sublingual Tablets | ClinicalTrials.gov |
| First posted | 2026-07-09 | ClinicalTrials.gov |
| Last updated | 2026-07-09 | ClinicalTrials.gov |
Registered outcomes 35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in whole-brain blood-brain barrier water exchange rate (kw) measured by DP-pCASL MRI | Baseline, Month 6, and Month 12 | The blood-brain barrier (BBB) water exchange rate (kw), an imaging marker of BBB function, is quantified on whole-brain diffusion-prepared pseudo-continuous arterial spin labeling (DP-pCASL) MRI at baseline, month 6, and month 12. All participants are untreated during the first 6 months (observation period) and receive edaravone dexborneol sublingual tablets during the subsequent 6 months (treatment period). The change in kw during the observation period (baseline to Month 6) is compared with the change during the treatment period (Month 6 to Month 12) to distinguish the natural trajectory of BBB dysfunction from a potential treatment effect. | ClinicalTrials.gov |
| Secondary | Clinical Stroke Events | 12 months | Number and proportion of participants experiencing any stroke event, including ischemic stroke and hemorrhagic stroke, recorded throughout the study. | ClinicalTrials.gov |
| Secondary | Change in Montreal Cognitive Assessment (MoCA) Score | Baseline, Month 6, and Month 12 | The Montreal Cognitive Assessment (MoCA) is a cognitive screening tool that assesses multiple domains, including attention, concentration, executive function, memory, language, visuospatial skills, abstract thinking, calculation, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive function. | ClinicalTrials.gov |
| Secondary | Change in Auditory Verbal Learning Test (AVLT) Score | Baseline, Month 6, and Month 12 | Verbal episodic memory is assessed using the Huashan version of the Auditory Verbal Learning Test (AVLT-H). The test uses a list of 12 words from three semantic categories (4 words per category). The examiner reads the list aloud and the participant recalls the words immediately; this is repeated for three consecutive trials. The immediate recall score is the sum of correctly recalled words across the three trials, ranging from 0 to 36, with higher scores indicating better memory function. | ClinicalTrials.gov |
| Secondary | Change in Boston Naming Test Score | Baseline, Month 6, and Month 12 | The Boston Naming Test (BNT) is a widely used neuropsychological assessment that measures confrontation naming-the ability to retrieve and produce the correct name for a visually presented object. Boston Naming Test includes 30 items and evaluates language through measuring the total of correct responses. The minimum score is 0, and the maximum score is 30. Higher score indicates better language. | ClinicalTrials.gov |
| Secondary | Change in Stroop Color-Word Test completion time | Baseline, Month 6, and Month 12 | Inhibitory function and executive control are assessed using the Stroop Color-Word Test. In the color-word interference condition, participants name the ink color of color words while inhibiting the automatic tendency to read the word. The outcome is the completion time in seconds; shorter times indicate better executive function. | ClinicalTrials.gov |
| Secondary | Change in Stroop Color-Word Test number of correct responses | Baseline, Month 6, and Month 12 | Inhibitory function and executive control are assessed using the Stroop Color-Word Test. In the color-word interference condition, participants name the ink color of color words while inhibiting the automatic tendency to read the word. The outcome is the number of correct responses, ranging from 0 to 50, with higher scores indicating better executive function. | ClinicalTrials.gov |
| Secondary | Change in Symbol Digit Modalities Test (SDMT) Score | Baseline, Month 6, and Month 12 | The total number of correct symbol-digit pairings completed within 90 seconds (common score range: 0-105), where a higher score indicates better processing speed, sustained attention, and visual scanning. | ClinicalTrials.gov |
| Secondary | Change in Trail Making Test (TMT) Score | Baseline, Month 6, and Month 12 | The Trail Making Test (TMT) is a widely used neuropsychological test that measures processing speed, visual attention, sequencing, mental flexibility, and executive function. The score is the time it takes to complete the task. Lower times are better, while longer times indicate greater impairment. | ClinicalTrials.gov |
| Secondary | Change in Digit Span Test (DST) Score | Baseline, Month 6, and Month 12 | Digit Span Test (DST) consists of forward and backward subtests, that respectively assess attention and executive function through measuring the number of correct digit sequences. The minimum score is 0 , and the maximum scores are respectively 10 and 9 for forward and backward subtests. The total score is the sum of the forward and backward subtests, ranging from 0 to 19, with higher scores indicating better attention and working memory. | ClinicalTrials.gov |
| Secondary | Change in Hamilton Anxiety Rating Scale (HAMA) score | Baseline, Month 6, and Month 12 | The Hamilton Anxiety Rating Scale (HAMA) is a clinician-administered scale used to assess the severity of anxiety symptoms. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms. | ClinicalTrials.gov |
| Secondary | Change in Hamilton Depression Rating Scale (HAMD) score | Baseline, Month 6, and Month 12 | The Hamilton Depression Rating Scale (HAMD) is a widely used clinical tool for assessing the severity of depression. It consists of multiple items that evaluate various aspects of depressive symptoms, including mood, guilt, suicidal ideation, work and interest, among others. It is scored on a scale from 0 to 52, with higher scores indicating more severe symptoms. | ClinicalTrials.gov |
| Secondary | Change in number of lacunes | Baseline, Month 6, and Month 12 | The change in the number of lacunes on brain MRI, assessed using T1-weighted, T2-weighted, and FLAIR sequences. Lacunes are markers of cerebral small vessel disease; an increased number may indicate progression of vascular pathology. | ClinicalTrials.gov |
| Secondary | Change in Number of Microbleeds | Baseline, Month 6, and Month 12 | The change in the number of cerebral microbleeds on brain MRI, assessed using susceptibility-weighted imaging (SWI) or T2\*-weighted gradient-echo imaging. Cerebral microbleeds are markers of cerebral small vessel disease; an increased burden may indicate worsening vascular pathology. | ClinicalTrials.gov |
| Secondary | Change in White Matter Hyperintensity Volume | Baseline, Month 6, and Month 12 | The change in white matter hyperintensity (WMH) volume, assessed using quantitative MRI analysis and reported in milliliters (mL). This measure evaluates the impact of treatment on the progression of cerebral small vessel disease. A smaller increase or a decrease in WMH volume suggests a treatment benefit. | ClinicalTrials.gov |
| Secondary | Change in perivascular space (PVS) score | Baseline, Month 6, and Month 12 | The change in the burden of enlarged perivascular spaces on brain MRI, rated on a validated visual rating scale (0 to 4) in the basal ganglia and centrum semiovale. Enlarged perivascular spaces are markers of cerebral small vessel disease; a higher score may indicate worsening vascular pathology. | ClinicalTrials.gov |
| Secondary | Change in total brain volume | Baseline, Month 6, and Month 12 | The change in total brain volume on brain MRI, assessed using quantitative volumetric analysis of 3D T1-weighted images and reported in milliliters (mL). Loss of brain volume reflects atrophy associated with cerebral small vessel disease; a greater reduction in brain volume may indicate disease progression. | ClinicalTrials.gov |
| Secondary | Change in fractional anisotropy (FA) | Baseline, Month 6, and Month 12 | The change in fractional anisotropy (FA) derived from diffusion tensor imaging (DTI), an index of white matter microstructural integrity. A decrease in FA reflects loss of white matter integrity and may indicate progression of cerebral small vessel disease. | ClinicalTrials.gov |
| Secondary | Change in mean diffusivity (MD) | Baseline, Month 6, and Month 12 | The change in mean diffusivity (MD) derived from diffusion tensor imaging (DTI). An increase in MD reflects loss of white matter microstructural integrity and may indicate progression of cerebral small vessel disease. | ClinicalTrials.gov |
| Secondary | Change in peak width of skeletonized mean diffusivity (PSMD) | Baseline, Month 6, and Month 12 | The change in peak width of skeletonized mean diffusivity (PSMD) derived from diffusion tensor imaging (DTI), a fully automated marker of cerebral small vessel disease. An increase in PSMD may indicate worsening white matter damage and disease progression. | 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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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 7
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 |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | 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)