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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Study to Evaluate the Efficacy and Safety of TTYP01 Tablets in Early Symptomatic Alzheimer's Disease (NCT07252440) is a Phase 2 interventional studying AD and Early Alzheimer's Disease, sponsored by Shanghai Auzone Biological Technology Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against AD and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 180 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused AD subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion Criteria Participants must meet all the following criteria to be eligible for this study: 1. Age between 60 and 85 years (inclusive, based on the date of signing the willing to sign a consent form), applicable to all genders. 2. Must meet the 2024 Alzheimer's Association (AA) Workgroup revised criteria for diagnosing MCI due to AD or mild AD dementia. 3. CDR score: At screening and baseline, the CDR global score must be 0.5 or 1.0, and the CDR memory score must be 0.5 or higher. 4. MMSE score: At screening, the MMSE score must be 22 or higher. 5. Body mass index (BMI): At screening, BMI must be greater than 17 and less than 35 (inclusive). 6. History of memory decline: A history of at least 6 months of gradual and progressive memory decline prior to signing ICF must be reported and confirmed by an informant. 7. Blood p-tau 217: positive (For participants with evidence suggesting Aβ-PET positivity, absence blood p-tau 217 determination is not considered a protocol deviation.). 8. Aβ- PET scan: Visual read of Aβ-PET scan must be positive. 9. Study partner: Must have a designated study partner who can support the participants and spend at least 8 h per week with them during the study. The partner must provide a separate written willing to sign a consent form and be willing and able to provide follow-up information about the participant. They should regularly spend enough time with the participants to reliably meet study requirements. The study partner does not need to live with the participant but should be easily reachable during the study. If the partner is unable to continue supporting due to health or other reasons, it is allowed to replace with another eligible partner. The replacement partner must provide a separate written willing to sign a consent form and be willing and able to provide follow-up information about the participant. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria Participants must meet all the following criteria to be eligible for this study: 1. Age between 60 and 85 years (inclusive, based on the date of signing the informed consent), applicable to all genders. 2. Must meet the 2024 Alzheimer's Association (AA) Workgroup revised criteria for diagnosing MCI due to AD or mild AD dementia. 3. CDR score: At screening and baseline, the CDR global score must be 0.5 or 1.0, and the CDR memory score must be 0.5 or higher. 4. MMSE score: At screening, the MMSE score must be 22 or higher. 5. Body mass index (BMI): At screening, BMI must be greater than 17 and less than 35 (inclusive). 6. History of memory decline: A history of at least 6 months of gradual and progressive memory decline prior to signing ICF must be reported and confirmed by an informant. 7. Blood p-tau 217: positive (For participants with evidence suggesting Aβ-PET positivity, absence blood p-tau 217 determination is not considered a protocol deviation.). 8. Aβ- PET scan: Visual read of Aβ-PET scan must be positive. 9. Study partner: Must have a designated study partner who can support the participants and spend at least 8 h per week with them during the study. The partner must provide a separate written informed consent and be willing and able to provide follow-up information about the participant. They should regularly spend enough time with the participants to reliably meet study requirements. The study partner does not need to live with the participant but should be easily reachable during the study. If the partner is unable to continue supporting due to health or other reasons, it is allowed to replace with another eligible partner. The replacement partner must provide a separate written informed consent and be willing and able to provide follow-up information about the participant. 10. Concomitant medication: Participants who are receiving cholinesterase inhibitors and/or memantine for AD can be enrolled into the study, but must be on a stable dose for at least 12 weeks prior to baseline. For all other (i.e., non-AD-related) allowed concomitant medications, participants must receive a stable dose (not for topical, as needed \[PRN\], or discontinued medications) for at least 4 weeks prior to baseline unless otherwise stated. 11. Contraception: a.Male participants i.Male participants, regardless of childbearing potential, if their non-pregnant female partner is a female of childbearing potential, must agree to maintain abstinence (if this is their preferred and usual lifestyle) or to use a barrier method and another highly effective (failure rate less than 1%) method of contraception (see Section 17.5 for details) until 90 days after the last dose of IP. ii.Male participants with pregnant partners should use condoms during intercourse for the duration of the study and until the end of the estimated relevant potential exposure for women of childbearing potential (WOCBP; expected to be 90 days after the last dose of IP). iii.Male participants should refrain from sperm donation for the duration of the study and until 90 days following the last dose of IP. b.Female participants i.WOCBP must use, or be willing to use, two forms of effective contraception (a barrier method and one other highly effective method of contraception, as detailed in Section 17.5) during participation in the trial and for 90 days after the last dose of the IP. ii.WOCBP potential is defined as those who are: ① Following menarche ② From the time of menarche until becoming postmenopausal unless permanently sterile (see below) A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. * In the absence of 12 months of amenorrhea, confirmation with more than one follicle-stimulating hormone (FSH) measurement is required. * Individuals receiving hormone replacement therapy (HRT) whose menopausal status is in doubt will be required to use a non-estrogenic, highly effective contraceptive method if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment. Permanent sterilization methods and gender-affirming procedures (for the purpose of this study) include: * Documented hysterectomy * Documented bilateral salpingectomy * Documented bilateral oophorectomy * For individuals with permanent infertility due to an alternate medical cause other than the above, (e.g., Mullerian agenesis, androgen insensitivity, gonadal dysgenesis), investigator discretion should be applied to determining study entry. iii.All WOCBP must be negative at Visit 1 based on a serum pregnancy test. 12. Informed consent: Must obtain a voluntary signed ICF, approved by an Ethics Committee, from the participants or their legal representative before any study procedure. 13. Language proficiency: Must be fluent in the language used at the study site. 14. Protocol compliance: Must be willing and able to comply with all aspects of the protocol. Exclusion Criteria Participants who meet any of the following exclusion criteria will not be eligible for the study: 1. History of intracranial infection or traumatic brain injury. 2. Severe coronary heart disease, cardiac insufficiency (New York Heart Association Class Ⅲ and Class IV), atrial fibrillation, and other heart diseases within six months prior to signing ICF. 3. Malignancy: * History of cancer within the last 3 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with a low risk of recurrence or spread. * Intracranial space occupying lesions or brain tumors will be excluded unless, based on the opinion of the investigators and medical monitors, the medical condition will not interfere with cognitive assessments and safety. 4. Severe hematologic disorders, such as myelodysplastic syndrome, aplastic anemia, lymphoma, leukemia, etc. 5. Peptic ulcer or obstruction or other diseases that affect the absorption of oral medication. 6. Any neurological disorder that may cause cognitive impairment beyond the impact of AD. 7. Any psychiatric diagnosis or neuropsychiatric symptom (such as hallucinations, major depression, or delusions) that may interfere with the participant's study procedure. 8. A history of transient ischemic attack (TIA), stroke, or seizure in the 12 months prior to signing ICF. 9. The Hachinski Ischemic Index Scale (HIS) at screening \> 4 points. 10. ECG at screening or at baseline showing prolonged QTcF \[Fridericia correction formula, see Section 17.4\] (QTcF \> 480 ms in women; QTcF \> 470 ms in men) or other clinically significant abnormalities of the ECG that are considered by the investigator to be unsuitable for participation in a clinical study (e.g., heart rate \< 50 beats/min, sinus node lesions, Morse II or third-degree atrioventricular block, etc.). 11. The Geriatric Depression Scale (GDS) score at screening ≥ 8 points. 12. Contraindications to MRI scans, including pacemakers/defibrillators, ferromagnetic metal implants (in addition to those approved for safe use in MRI scanners, such as cranial and cardiac devices). 13. Contraindications with PET scanning, allergies to tracers. 14. Brain MRI at screening reveals evidence of other clinically significant lesions, suggesting a possible diagnosis of dementia other than AD. 15. Brain MRI at screening reveals the presence of a single hemorrhage with a maximum diameter \> 10 mm and investigator assesses the participant is unsuitable for this study; Evidence of angioedema. 16. Participants with inadequately controlled bleeding disorder (including platelet count \< 100,000/µL or international normalized ratio \[INR\] \> 1.5). 17. Thyroid stimulating hormone levels above or below the normal range. Participants with results of other thyroid function tests that fall outside the normal range will be excluded only if they are considered clinically significant by the investigator. 18. Laboratory test results for serum vitamin B12 levels below the normal range, as well as participants who are receiving vitamin B12 supplement therapy. 19. Positive serological finding for human immunodeficiency virus (HIV), active syphilis, Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody. 20. Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG present at screening or baseline that the investigator determines the situations that affected the safety of the participants or other interferences with the study. 21. Have a known or suspected history of drug or alcohol abuse. 22. Serious or unstable disease, or any other medical condition (e.g., heart, respiratory, gastrointestinal, liver, kidney, endocrine and nervous system disease, including poorly controlled hypertension, with a systolic blood pressure of ≥160mmHg or a diastolic blood pressure of ≥100 mmHg; Poorly controlled diabetes, etc.) that the investigator believes may affect the participant's safety or interfere with study evaluation. 23. Previous use of prohibited drugs, including disease-modifying drugs (Such as approved lecanemab, donemab, etc. or other disease-modifying investigational medicinal products), anti-oxidative stress drugs (other formulations of edaravone). 24. Have scheduled surgical procedures requiring general anesthesia during the study period. For a scheduled procedure that requires only local anesthesia and performed as a day procedure without the need for post-operative hospitalization, participant does not need to be excluded if the investigator determines that the procedure does not interfere with study procedures or participant safety. 25. Severe vision, hearing, reading, comprehension, or physical dysfunction that prevents the participant from accurately performing neuropsychological tests. 26. Have been diagnosed with serious active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc., or alanine transaminase (ALT) \> 2 × upper limit of normal (ULN) or aspartate aminotransferase (AST) \> 2 × ULN, or total bilirubin (TBIL) \> 1.5 × ULN. 27. Have been diagnosed with severe active kidney disease, renal insufficiency; or serum creatinine \> 1.5 × ULN or creatinine clearance \< 50 mL/min at screening and baseline (Calculated based on the Cockcroft-Gault formula, see Section 17.6 for details). 28. Have severe systemic disease and life expectancy is \< 2 years. 29. Answer "yes" to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before screening, at screening, or at the baseline visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before screening. 30. Allergic to edaravone, sodium bisulfite, or soluplus excipients (Note: Asthma patients are sensitive to sulfites and may have allergic reactions. For patients with a history of asthma, the investigator will carefully assess whether to enroll them.). 31. History of major surgery within 4 weeks prior to enrollment. 32. Have participated in, or are currently participating in, another clinical study within the 30 days prior to randomization (Participants who have previously participated in clinical studies of disease-modifying drugs targeting Aβ and/or tau pathology will follow exclusion criteria 23). 33. Participants who have received cholinesterase inhibitors, memantine within 12 weeks prior to randomization and stopped treatment due to safety concerns or other reasons and refuse to or unable to receive it again. 34. Female participants who are pregnant, breastfeeding, planning to become pregnant recently, or unwilling to use contraceptive measures. 35. Have other conditions that investigator believes the participant is unsuitable for this study.

Treatments Being Tested

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Daping Hospital.
Chongqing, Chongqing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07252440), the sponsor (Shanghai Auzone Biological Technology Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07252440 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07252440?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07252440?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07252440. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07252440. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.