Actively Recruiting
A Study to Evaluate the Efficacy and Safety of TTYP01 Tablets in Early Symptomatic Alzheimer's Disease
Led by Shanghai Auzone Biological Technology Co., Ltd. · Updated on 2025-11-26
180
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Efficacy and Safety of TTYP01 Tablets in Early Symptomatic Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 60 and 85 years inclusive
- Diagnosed with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia based on 2024 Alzheimer's Association criteria
- CDR global score of 0.5 or 1.0 and CDR memory score of 0.5 or higher at screening and baseline
- MMSE score of 22 or higher at screening
- Body mass index between 17 and 35 inclusive at screening
- History of gradual and progressive memory decline for at least 6 months confirmed by an informant
- Positive blood p-tau 217 test or positive Ab2-PET scan
- Have a study partner who can support and spend at least 8 hours per week with the participant
- Stable dose of cholinesterase inhibitors and/or memantine for at least 12 weeks prior to baseline if used
- Willingness to use appropriate contraception measures according to gender and childbearing potential
- Able to give informed consent or have a legal representative provide consent
- Fluent in the language used at the study site
- Willing and able to comply with study protocol
You will not qualify if you...
- History of intracranial infection or traumatic brain injury
- Severe heart disease or atrial fibrillation within 6 months prior to enrollment
- History of cancer within last 3 years except certain low-risk types
- Severe blood disorders such as myelodysplastic syndrome or leukemia
- Diseases affecting absorption of oral medication
- Neurological disorders causing cognitive impairment beyond Alzheimer's
- Psychiatric conditions that interfere with study participation
- Stroke, TIA, or seizure within 12 months prior to enrollment
- Hachinski Ischemic Index greater than 4 points
- ECG abnormalities including prolonged QTcF or heart block
- Geriatric Depression Scale score 8 or higher
- Contraindications to MRI or PET scanning
- Brain lesions or hemorrhages unsuitable for study
- Uncontrolled bleeding disorders or abnormal thyroid function
- Positive tests for HIV, active syphilis, Hepatitis B or C
- Significant abnormalities in exams or labs affecting safety
- History of drug or alcohol abuse
- Serious or unstable diseases affecting safety or evaluation
- Previous use of prohibited drugs including certain disease-modifying therapies
- Scheduled surgeries requiring general anesthesia during study
- Severe sensory or physical dysfunction preventing test completion
- Active liver or kidney disease beyond specified limits
- Life expectancy less than 2 years
- Recent suicidal ideation or behavior
- Allergies to study drug components
- Major surgery within 4 weeks prior to enrollment
- Participation in another clinical study within 30 days prior to randomization
- Discontinued cholinesterase inhibitors or memantine due to safety or other concerns and unwilling to resume
- Female participants who are pregnant, breastfeeding, or unwilling to use contraception
- Any other condition making participant unsuitable for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Daping Hospital.
Chongqing, Chongqing Municipality, China, 400042
Actively Recruiting
Research Team
Y
Yan-Jiang Wang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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