This is a multicenter, randomized, double-blind, placebo-controlled parallel Phase II core period study to evaluate the efficacy and safety of TTYP01 Tablets in early symptomatic AD (Mild cognitive impairment \[MCI\] due to AD, or mild AD dementia).
A total of 180 participants will be randomized into 3 parallel groups: 2 TTYP01 dose groups and 1 placebo group.
Age between 55 and 85 years (inclusive, based on the date of signing the informed consent), applicable to all genders.
Must meet the 2024 NIA-AA revised criteria for diagnosing MCI due to AD or mild AD dementia.
CDR score: At screening and baseline, the CDR-GS must be 0.5 or 1.0, and the CDR memory score must be0.5 or higher.
MMSE score: At screening, the MMSE score must be 20 or higher.
History of intracranial infection or traumatic brain injury, that is deemed unsuitable for this study based on the judgment by the investigators.
Severe coronary heart disease, cardiac insufficiency (New York Heart Association Class Ⅲ and Class IV), atrial fibrillation, and other heart diseases that are deemed unsuitable for this study based on the judgment by the investigators.
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.
Severe hematologic disorders, such as myelodysplastic syndrome, aplastic anemia, lymphoma, leukemia, etc.