Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients

Inclusion Criteria:

1. Age ≥ 40 years and ≤ 80 years, male or female.

2. Diagnosed as ischemic stroke, no significant pre-stroke functional disability (mRSscore ≤ 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 7days).

5. A baseline MMSE score of mild dementia severity was required: ≤20 points forsubjects with elementary school education and ≤24 points for subjects with secondaryschool education and above for mild dementia severity;

6. Presence of cognitive dysfunction at screening, i.e., MoCA scale score < 22.

7. Patients with good cognitive function prior to stroke, without significant cognitivedysfunction and dementia.

8. Education level: primary school or above, and can complete the cognitive functiontest required per investigator's judgement.

9. female subjects of childbearing potential and male subjects whose female partnersare of childbearing potential must be willing to and use contraception during thestudy treatment and within 30 days after the last dose of study drug and have noplans to donate sperm or eggs; female subjects of childbearing potential will have anegative pregnancy test;

10. obtain voluntary signed informed consent from the patient or his/her legalrepresentative approved by the Ethics Committee.

Exclusion Criteria:

1. Presence of intracranial hemorrhagic disease confirmed by brain imaging.

2. Severe disturbance of consciousness: NIHSS 1a level of consciousness item score > 1point.

3. Transient ischemic attack (TIA).

4. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg afterblood 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 scorewas ≥ 51.

9. Patients who have been diagnosed with severe mental disorders prior to stroke.

10. Severe limb hemiplegia and aphasia and significantly affect cognitive functionassessment.

11. Patients have received the cognitive enhancers and other anti-dementia drugs within 1 month before the screening period, including but not limited to cholinesteraseinhibitors (donepezil, rivastigmine, galantamine) and non-competitiveN-methyl-D-aspartate (NMDA) receptor antagonists (memantine) and other drugs (suchas mannitol sodium capsules, Ginkgo Biloba Extract Injection, Compound Ginkgo BilobaTablets, 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 serumcreatinine > 1.5 × ULN.

14. Thrombectomy or interventional therapy has been applied or planned after thisepisode.

15. History of malignancy; except for subjects with non-melanoma skin cancer (NMSC) thathas been successfully treated and limited cervical cancer in situ. Subjects with adiagnosis of malignancy after enrollment may continue to participate in the study ornot at the discretion of the investigator and at the discretion of the subject;

16. Suffering from a severe systemic disease with an expected survival period of <1year;

17. hypersensitivity to dextran camphene, natural ice chips or edaravone or excipients (mannitol, copovidone, microcrystalline cellulose, cross-linked povidone, silicondioxide, magnesium stearate);

18. pregnancy, lactation, and patients planning pregnancy;

19. history of major surgery within 4 weeks prior to enrollment;

20. participation in another clinical study within 30 days prior to randomization, orongoing participation in another clinical study;

21. in the opinion of the investigator, not suitable for participation in this clinicalstudy.