Efficacy and Safety of Edaravone Dexborneol Sublingual Tablet for Post-stroke Cognitive Impairment in Patients With Acute Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled, Exploratory Phase II Clinical Trial.

SIM0308-02-Y-2-201

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.

2024-04-08

2025-12-30

2025-12-30

Recruiting

Early phase I

80

Inclusion Criteria: 1. Age ≥ 40 years and ≤ 80 years, male or female. 2. Diagnosed as ischemic stroke, no significant pre-stroke functional disability (mRS score ≤ 1prior to stroke onset). 3. The National Institutes of Stroke Scale score ≤ 20 points. 4. Time from onset to obtained informed consent form is within 7 days (including 7 days). 5. Presence of cognitive dysfunction at screening, i.e., MoCA scale score \< 22. 6. Patients with good cognitive function prior to stroke, without significant cognitive dysfunction and dementia. 7. Education level: primary school or above, and can complete the cognitive function test required per investigator's judgement. Exclusion Criteria: 1. Presence of intracranial hemorrhagic disease confirmed by brain imaging. 2. Severe disturbance of consciousness: NIHSS 1a level of consciousness item score \> 1 point. 3. Transient ischemic attack (TIA). 4. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control. 5. Poorly controlled diabetes (fasting blood glucose \>10mmol/L and/or HbA1c\>8%). 6. Patients with contraindications to MRI imaging. 7. Patients with contraindications for EEG examination. 8. Presence of cognitive dysfunction prior to stroke assessed by informants, that is, the average score of Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE, 16-item version) during the screening period was ≥ 3.19 and the total score was ≥ 51. 9. Patients who have been diagnosed with severe mental disorders prior to stroke. 10. Severe limb hemiplegia and aphasia and significantly affect cognitive function assessment. 11. Patients have received the cognitive enhancers and other anti-dementia drugs within 1 month before the screening period, including but not limited to cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and non-competitive N-methyl-D-aspartate (NMDA) receptor antagonists (memantine) and other drugs (such as mannitol sodium capsules, Ginkgo biloba preparations, oxiracetam, aniracetam, piracetam，nicergoline, Lecanemab, Donanemab, Aducanumab, etc. ). 12. Have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT or AST \> 2.0 × ULN. 13. Has been diagnosed with severe active kidney disease, renal insufficiency; or serum creatinine \> 1.5 × ULN. 14. Thrombectomy or interventional therapy has been applied or planned after this episode.

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2024-09-20