A Study to Evaluate the Efficacy and Safety of TTYP01 Tablets in Early Symptomatic Alzheimer's Disease

Exclusion Criteria

• •1. History of intracranial infection or traumatic brain injury.
• •2. Severe coronary heart disease, cardiac insufficiency (New York Heart Association Class Ⅲ and Class IV), atrial fibrillation, and other heart diseases within six months prior to signing ICF.
• •3. Malignancy:
• •* History of cancer within the last 3 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with a low risk of recurrence or spread.
• •* Intracranial space occupying lesions or brain tumors will be excluded unless, based on the opinion of the investigators and medical monitors, the medical condition will not interfere with cognitive assessments and safety.
• •4. Severe hematologic disorders, such as myelodysplastic syndrome, aplastic anemia, lymphoma, leukemia, etc.
• •5. Peptic ulcer or obstruction or other diseases that affect the absorption of oral medication.
• •6. Any neurological disorder that may cause cognitive impairment beyond the impact of AD.
• •7. Any psychiatric diagnosis or neuropsychiatric symptom (such as hallucinations, major depression, or delusions) that may interfere with the participant's study procedure.
• •8. A history of transient ischemic attack (TIA), stroke, or seizure in the 12 months prior to signing ICF.
• •9. The Hachinski Ischemic Index Scale (HIS) at screening \> 4 points.
• •10. ECG at screening or at baseline showing prolonged QTcF \[Fridericia correction formula, see Section 17.4\] (QTcF \> 480 ms in women; QTcF \> 470 ms in men) or other clinically significant abnormalities of the ECG that are considered by the investigator to be unsuitable for participation in a clinical study (e.g., heart rate \< 50 beats/min, sinus node lesions, Morse II or third-degree atrioventricular block, etc.).
• •11. The Geriatric Depression Scale (GDS) score at screening ≥ 8 points.
• •12. Contraindications to MRI scans, including pacemakers/defibrillators, ferromagnetic metal implants (in addition to those approved for safe use in MRI scanners, such as cranial and cardiac devices).
• •13. Contraindications with PET scanning, allergies to tracers.
• •14. Brain MRI at screening reveals evidence of other clinically significant lesions, suggesting a possible diagnosis of dementia other than AD.
• •15. Brain MRI at screening reveals the presence of a single hemorrhage with a maximum diameter \> 10 mm and investigator assesses the participant is unsuitable for this study; Evidence of angioedema.
• •16. Participants with inadequately controlled bleeding disorder (including platelet count \< 100,000/µL or international normalized ratio \[INR\] \> 1.5).
• •17. Thyroid stimulating hormone levels above or below the normal range. Participants with results of other thyroid function tests that fall outside the normal range will be excluded only if they are considered clinically significant by the investigator.
• •18. Laboratory test results for serum vitamin B12 levels below the normal range, as well as participants who are receiving vitamin B12 supplement therapy.
• •19. Positive serological finding for human immunodeficiency virus (HIV), active syphilis, Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody.
• •20. Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG present at screening or baseline that the investigator determines the situations that affected the safety of the participants or other interferences with the study.
• •21. Have a known or suspected history of drug or alcohol abuse.
• •22. Serious or unstable disease, or any other medical condition (e.g., heart, respiratory, gastrointestinal, liver, kidney, endocrine and nervous system disease, including poorly controlled hypertension, with a systolic blood pressure of ≥160mmHg or a diastolic blood pressure of ≥100 mmHg; Poorly controlled diabetes, etc.) that the investigator believes may affect the participant's safety or interfere with study evaluation.
• •23. Previous use of prohibited drugs, including disease-modifying drugs (Such as approved lecanemab, donemab, etc. or other disease-modifying investigational medicinal products), anti-oxidative stress drugs (other formulations of edaravone).
• •24. Have scheduled surgical procedures requiring general anesthesia during the study period. For a scheduled procedure that requires only local anesthesia and performed as a day procedure without the need for post-operative hospitalization, participant does not need to be excluded if the investigator determines that the procedure does not interfere with study procedures or participant safety.
• •25. Severe vision, hearing, reading, comprehension, or physical dysfunction that prevents the participant from accurately performing neuropsychological tests.
• •26. Have been diagnosed with serious active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc., or alanine transaminase (ALT) \> 2 × upper limit of normal (ULN) or aspartate aminotransferase (AST) \> 2 × ULN, or total bilirubin (TBIL) \> 1.5 × ULN.
• •27. Have been diagnosed with severe active kidney disease, renal insufficiency; or serum creatinine \> 1.5 × ULN or creatinine clearance \< 50 mL/min at screening and baseline (Calculated based on the Cockcroft-Gault formula, see Section 17.6 for details).
• •28. Have severe systemic disease and life expectancy is \< 2 years.
• •29. Answer "yes" to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before screening, at screening, or at the baseline visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before screening.
• •30. Allergic to edaravone, sodium bisulfite, or soluplus excipients (Note: Asthma patients are sensitive to sulfites and may have allergic reactions. For patients with a history of asthma, the investigator will carefully assess whether to enroll them.).
• •31. History of major surgery within 4 weeks prior to enrollment.
• •33. Participants who have received cholinesterase inhibitors, memantine within 12 weeks prior to randomization and stopped treatment due to safety concerns or other reasons and refuse to or unable to receive it again.
• •34. Female participants who are pregnant, breastfeeding, planning to become pregnant recently, or unwilling to use contraceptive measures.
• •35. Have other conditions that investigator believes the participant is unsuitable for this study.