International Phase II Trial Evaluating TTYP01 Tablets for Early Symptomatic Alzheimers Disease in Adults Aged 55 to 85

What this Trial Is About

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase II study to assess the efficacy and safety of TTYP01 tablets in adults aged 55 to 85 years with early symptomatic Alzheimers disease, including mild cognitive impairment due to AD or mild AD dementia. The study plans to enroll 180 participants who meet specific diagnostic criteria and cognitive assessments. Participants will be randomly assigned to one of three groups a low-dose group receiving 60 mg TTYP01 tablets twice daily, a high-dose group receiving 90 mg TTYP01 tablets twice daily, or a placebo group. The treatment period lasts for 78 weeks, during which participants will take the assigned tablets twice daily. The study evaluates changes in cognitive function and safety outcomes over this period. During the trial, participants will undergo regular assessments including the Clinical Dementia Rating Scale-Sum of Boxes CDR-SB, Mini-Mental State Examination MMSE, Alzheimer Disease Assessment Scale-Cognitive Subscale ADAS-cog13, amyloid PET scans, and blood biomarker tests such as p-tau 217. Safety will be monitored by recording adverse events and other clinical evaluations. The total participation extends up to 78 weeks with scheduled visits and evaluations to track treatment effects and participant well-being.

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