MedTrace Logo

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

NCT07252440 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-11-26

No results posted yet for this study

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

DRUG

TTYP01 tables 90mg

(3 TTYP01 30 mg tablets

DRUG

TTYP01 tables 0mg

3 placebo tablets

DRUG

TTYP01 tables 60mg

2 TTYP01 30 mg tablets + 1 placebo tablet BID

Sponsors & Collaborators

  • Shanghai Auzone Biological Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2028-10-23
Completion
2028-11-23

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07252440 on ClinicalTrials.gov