Cerebral small vessel disease
Conditions
Interventions
Experimental group:Edaravone sublingual tablets 60mg, to be taken sublingually once daily for 24 weeks.
Control group:Placebo tablets 60mg, to be taken sublingually once daily for 24 weeks
Sponsors
Nanjing Drum Tower Hospital, Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: Age between 50-80 years old; Clinically diagnosed with cerebral small vessel disease, with cognitive decline [Montreal Cognitive Assessment (MoCA) score <=13 for illiterates, <=19 for 1-6 years of education, and <=25 for more than 7 years of education], and cranial MRI showing signs of white matter hyperintensities (Fazekas grade 1 or higher), lacunar infarcts, cerebral microbleeds, or enlarged perivascular spaces. The Assessment of Daily Living (ADL) scale is within the normal range for age and education level; The patient or their legal representative has signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Concurrent Alzheimer's disease, Parkinson's disease, and Lewy body dementia, and other cognitive impairment diseases; 2) History of ischemic stroke with cerebral infarction lesions diameter > 15mm, or history of cardiogenic cerebral infarction; 3) Concurrent multiple sclerosis, radiation brain injury, neuromyelitis optica, and cerebral amyloid angiopathy, and other diseases caused by poisoning, immune, metabolic, genetic, and infectious factors leading to other white matter lesions of the brain; 4) Concurrent intracranial hemorrhage, traumatic brain injury, brain tumor, and severe somatic diseases such as thyroid disease, anemia, and malignant tumors; 5) Concurrent severe vision abnormalities, hearing impairment, and hemiplegia that prevent clinical assessment from being conducted; 6) Concurrent renal dysfunction, liver dysfunction, or severe heart failure; 7) Known allergy to edaravone and ginkgo biloba preparations; 8) History of mental system diseases; 9) Other life-threatening or severe diseases, with an expected survival of less than 36 months; 10) The investigator believes that the subject has potential risks or any other factors that interfere with the subject, making them unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MoCA scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| MMSE scores;Digit span test scores;TMT-B scores;Activities of daily living scores;Deep cerebral blood flow;ALPS;Cerebral small vessel disease lesion burden; | — |
Countries
China
Contacts
Public ContactQing Ye
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Outcome results
None listed