RecruitingPhase 2NCT07252440

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


Sponsor

Shanghai Auzone Biological Technology Co., Ltd.

Enrollment

180 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called TTYP01 in patients with early symptomatic Alzheimer's disease — specifically mild cognitive impairment (MCI) or mild Alzheimer's dementia — to see if it can improve or slow the decline in memory and thinking. Participants must have biological evidence of Alzheimer's confirmed through blood tests or brain scans. **You may be eligible if...** - You are between 60 and 85 years old - You have confirmed MCI due to Alzheimer's or mild Alzheimer's dementia - Your cognitive test scores are within a specified range (MMSE ≥22, CDR 0.5–1.0) - You have a positive blood test for a protein called p-tau 217 and/or a positive amyloid PET brain scan - You have a study partner (family member or caregiver) who can spend at least 8 hours per week with you - You have been experiencing gradual memory decline for at least 6 months **You may NOT be eligible if...** - You have had a brain infection or traumatic brain injury - You have severe heart disease, atrial fibrillation, or recent heart failure - You have another cause of cognitive impairment beyond Alzheimer's - You have a history of stroke or seizure in the past year - You have significant depression symptoms - You have active cancer (within the past 3 years, with some exceptions) - You have HIV, active syphilis, hepatitis B, or hepatitis C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTTYP01 tables 60mg

2 TTYP01 30 mg tablets + 1 placebo tablet BID

DRUGTTYP01 tables 90mg

(3 TTYP01 30 mg tablets

DRUGTTYP01 tables 0mg

3 placebo tablets


Locations(1)

Daping Hospital.

Chongqing, Chongqing Municipality, China

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NCT07252440


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