Cerebral small vessel disease
Conditions
Interventions
Drug Group:Edaravone 30mg, three times daily, oral
Control Group:None (Placebo)
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years; 2. No gender restriction; 3. Brain MRI shows cerebral small vessel disease: white matter hyperintensities with Fazekas score =2, and meeting at least one of the following: (1) Presence of =1 vascular risk factor[1]; (2) Presence of lacunes[2]; 4. Baseline MoCA score between 18 and 25 after education-adjustment[3] (18=MoCA=25); 5. Cognitive impairment does not impair independence in daily living (mRS=2); 6. Able to comply with follow-up visits; 7. Signed informed consent form; Notes: [1] Vascular risk factors include but are not limited to hypertension, diabetes, hyperlipidemia, and current smoking; [2] Lacunes: According to STRIVE-2 criteria, lacunes are subcortical, round or oval fluid-filled cavities with diameter generally <15 mm; [3] If the subject’s education duration is =12 years (high school level), add 1 point to the score, but the total score must not exceed 30.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to any component of the investigational drug or history of severe allergy; 2. Clearly diagnosed with other conditions causing cognitive impairment, including but not limited to: acute ischemic stroke, history of large-area infarction, Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease, frontotemporal dementia, subdural hematoma, normal pressure hydrocephalus, brain tumor, drug intoxication, alcohol intoxication, thyroid disease, vitamin deficiency, major depression; 3. Received or currently taking drugs for cognitive impairment within 4 weeks prior to randomization; 4. Concurrent severe stenosis (>70%) of the intracranial internal carotid artery or middle cerebral artery; 5. Clearly diagnosed with hereditary cerebral small vessel disease[1]; 6. Accompanied by organic psychosis meeting DSM-V criteria or high suicide risk; 7. Concurrent severe neurological deficits preventing completion of assessments or scale evaluations; 8. Concurrent severe gastrointestinal disease affecting drug absorption or inability to swallow pills; 9. Liver enzymes (ALT, AST) or creatinine >3 times the upper limit of normal, or estimated glomerular filtration rate <60 mL/min; 10. Pregnant, lactating, or planning pregnancy; 11. Suffering from severe organic disease with expected survival time <1 year; 12. Contraindication to MRI examination; 13. Currently participating in another clinical trial; Note: [1] For patients aged <35 years, additional testing must be performed to exclude hereditary cerebral small vessel disease before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MoCA score from baseline at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| MoCA score at 6 months;MoCA score at 3 months;MMSE score at 6 months;MMSE score at 3 months;Change in Color Trails Test (CTT) score at 6 months;Change in Stroop Color and Word Test (SCWT) score at 6 months;Change in Auditory Verbal Learning Test (AVLT) score at 6 months;Change in Boston Naming Test (BNT) score at 6 months;Hamilton Depression Rating Scale (HAMD) score at 6 months;Hamilton Anxiety Rating Scale (HAMA) score at 6 months;Barthel Index (BI) score at 6 months;Functional Activities Questionnaire (FAQ) score at 6 months;Fazekas score at 6 months;White matter hyperintensity (WMH) volume at 6 months;Lacunar burden at 6 months;Cerebral blood flow (CBF) at 6 months;Metabolomic biomarkers at 6 months; | — |
Countries
China
Contacts
Public ContactWu Wei
Qilu Hospital of Shandong University
Outcome results
None listed