This is a multicenter, randomized, double-blind, placebo-controlled, exploratory Phase II clinical trial.
The goal of this clinical trial is to assess the safety and efficacy of edaravone dexborneol sublingual tablets for post-stroke cognitive impairment in patients with acute ischemic stroke.
Participants will be required to receive 24 weeks treatment of edaravone dexborneol sublingual tablets or placebo during this study. The safety and efficacy endpoints will be compared in the patients with edaravone dexborneol sublingual tablets or placebo.
Age ≥ 40 years and ≤ 80 years, male or female.
Diagnosed as ischemic stroke, no significant pre-stroke functional disability (mRS score ≤ 1prior to stroke onset).
The National Institutes of Stroke Scale score ≤ 20 points.
Time from onset to obtained informed consent form is within 7 days (including 7 days).
Presence of intracranial hemorrhagic disease confirmed by brain imaging.
Severe disturbance of consciousness: NIHSS 1a level of consciousness item score > 1 point.
Transient ischemic attack (TIA).
Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control.
Parallel
Edaravone dexborneol sublingual tablet
DrugPatients will receive one edaravone dexborneol sublingual tablet twice daily for 24 weeks
Placebo
DrugPatients will receive one placebo twice daily for 24 weeks
Adverse Events
Adverse events (AE), treatment-related adverse events (TRAE), serious adverse events (SAE) in each group.
Number of discontinuation/withdrawal patients
Discontinuation/withdrawal of patients in each group, including discontinuation due to adverse events.
The changes of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) scores.
The changes of the scores of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) in each group after 24 weeks of treatment were compared with baseline. The minimum score is 0 and maximum score is 115 and the higher scores means the worse outcome.
The incidence of Post Stroke Cognitive Impairment（PSCI ）in each group
The incidence of PSCI in each group at the 12th and 24th week of treatment, defined as Proportion of patients with MoCA score \<22
The changes of Mini-Mental State Examination (MMSE) score
Mini-Mental State Examination (MMSE) at the 12th and 24th week of treatment (MMSE) score changes from baseline. The minimum score is 0 and maximum score is 30 and the higher scores means the better outcome.
The changes of Montreal Cognitive Assessment (MoCA) scale
Montreal Cognitive Assessment at the 12th and 24th week of treatment (MoCA) scale score changes from baseline. The minimum score is 0 and maximum score is 30 and the higher scores means the better outcome.
The changes of MoCA subscales
MoCA subscales (including visuospatial and execution) at the 12th and 24th week of treatment Function, naming, delayed recall, attention, language, abstraction, Orientation 7 subitems) from baseline. The minimum score is 0 and maximum score is 30 and the higher scores means the better outcome.
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