NCT07252440

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

A Prospective, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of TTYP01 Tablets in Early Symptomatic Alzheimer's Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Shanghai Auzone Biological Technology Co., Ltd. · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• AD
• Early Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	TTYP01 tables 60mg	2 TTYP01 30 mg tablets + 1 placebo tablet BID
DRUG	TTYP01 tables 90mg	(3 TTYP01 30 mg tablets
DRUG	TTYP01 tables 0mg	3 placebo tablets

Timeline

• Start date: 2025-12-05
• Primary completion: 2028-10-23
• Completion: 2028-11-23
• First posted: 2025-11-26
• Last updated: 2025-11-26

Locations

1 site across 1 country: China