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A Prospective, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled 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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of TTYP01 tablets in people with early symptomatic Alzheimer's disease, including mild cognitive impairment due to Alzheimer's and mild Alzheimer's dementia. This Phase II, randomized, double-blind, placebo-controlled trial involves 180 participants divided into three groups: two different TTYP01 dose groups and one placebo group to compare treatment effects. Participants will receive either 60 mg TTYP01 (two 30 mg tablets plus one placebo tablet) twice daily, 90 mg TTYP01 (three 30 mg tablets) twice daily, or three placebo tablets twice daily. The study is designed with a core period lasting 78 weeks, during which participants take the assigned tablets regularly. This design helps researchers assess the different doses against placebo under controlled conditions. During the study, participants will undergo regular assessments including the Clinical Dementia Rating Scale-Sum of Boxes, Mini-Mental State Examination, Alzheimer Disease Assessment Scale-Cognitive Subscale, amyloid PET scans, and blood tests for biomarkers like p-tau 217. Safety monitoring includes tracking adverse events and serious adverse events throughout the 78 weeks. Participants will be supported by a study partner and will have study visits to evaluate cognitive function, biomarker changes, and drug levels, ensuring comprehensive monitoring over the study duration.
CONDITIONS
Brief 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, any gender
- Meet 2024 Alzheimer's Association criteria for mild cognitive impairment due to Alzheimer's or mild Alzheimer's dementia
- Clinical Dementia Rating (CDR) global score of 0.5 or 1.0 and memory score of 0.5 or higher at screening and baseline
- Mini-Mental State Examination (MMSE) score of 22 or higher at screening
- Body mass index (BMI) between 17 and 35 inclusive at screening
- History of gradual memory decline for at least 6 months confirmed by an informant
- Positive blood p-tau 217 or positive amyloid-beta PET scan
- Have a study partner who can support and spend at least 8 hours per week with the participant during the study
- Stable dose of cholinesterase inhibitors and/or memantine for at least 12 weeks prior to baseline if used
- Agree to use effective contraception if of childbearing potential
- Signed informed consent and fluency in the study site language
- 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
- Recent cancer history within 3 years except certain low-risk types
- Severe blood disorders such as lymphoma or leukemia
- Conditions affecting oral medication absorption
- Neurological or psychiatric disorders interfering with study procedures
- Recent transient ischemic attack, stroke, or seizure within 12 months
- Elevated Hachinski Ischemic Index score (>4)
- Abnormal ECG findings unsuitable for study
- High Geriatric Depression Scale score (≥8)
- Contraindications to MRI or PET scanning
- Brain MRI showing lesions or hemorrhages unsuitable for study
- Uncontrolled bleeding disorders or abnormal thyroid function
- Positive tests for HIV, syphilis, Hepatitis B or C
- History of drug or alcohol abuse
- Serious or unstable medical conditions affecting safety or study evaluation
- Previous use of prohibited disease-modifying or anti-oxidative stress drugs
- Scheduled surgeries requiring general anesthesia during study
- Severe sensory or physical impairments preventing test performance
- Active liver or kidney disease beyond set thresholds
- Life expectancy under 2 years
- Recent suicidal ideation or behavior
- Allergies to study drug components
- Major surgery within 4 weeks prior to enrollment
- Participation in another clinical trial within 30 days prior to randomization
- Refusal or inability to restart certain Alzheimer's medications
- Female participants who are pregnant, breastfeeding, or unwilling to use contraception
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 78 weeks
Participants receive TTYP01 tablets or placebo twice daily to evaluate efficacy and safety in early symptomatic Alzheimer's disease.
Regular visits for assessments at Weeks 13, 26, 39, 52, 65, and 78
Trial Site Locations
Total: 1 location
1
Daping Hospital.
Chongqing, Chongqing Municipality, China, 400042
Actively Recruiting
Research Team
Y
Yan-Jiang Wang, MD, PhD
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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