ADPhase 2NCT07252440
A Study to Evaluate the Efficacy and Safety of TTYP01 Tablets in Early Symptomatic Alzheimer's Disease
A Phase 2 study testing TTYP01 tables 60mg, TTYP01 tables 90mg and TTYP01 tables 0mg in people with AD and Early Alzheimer's Disease, run by Shanghai Auzone Biological Technology Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- AD, Early Alzheimer's Disease
- What is being tested?
- TTYP01 tables 60mg, TTYP01 tables 90mg and TTYP01 tables 0mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2025to 23 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all the following criteria to be eligible for this study:
- Age between 55 and 85 years (inclusive, based on the date of signing the informed consent), applicable to all genders.
- Must meet the 2024 NIA-AA revised criteria for diagnosing MCI due to AD or mild AD dementia.
- CDR score: At screening and baseline, the CDR-GS must be 0.5 or 1.0, and the CDR memory score must be0.5 or higher.
- MMSE score: At screening, the MMSE score must be 20 or higher.
- Body mass index (BMI): At screening, BMI must be greater than 17 and less than 35 (inclusive).
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- 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.
- Blood p-tau 217: positive.
- Aβ- PET scan: Visual read of Aβ-PET scan must be positive.
- 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.
- Concomitant medication: Participants who are receiving cholinesterase inhibitors (donepezil, rivastigmine, galantamine, huperzine A, etc.) and/or memantine and other AD symptomatic treatment drugs for AD can be enrolled into the study, but must be on a stable dose for at least 4 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.
- Contraception:
- 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.
- 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).
- Male participants should refrain from sperm donation for the duration of the study and until 90 days following the last dose of IP.
- 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.
- 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.
- All WOCBP must be negative at Visit 1 based on a serum pregnancy test.
- Informed consent: Must obtain a voluntary signed ICF, approved by an Ethics Committee, from the participants or their legal representative before any study procedure.
- Language proficiency: Must be fluent in the language used at the study site.
- Protocol compliance: Must be willing and able to comply with all aspects of the protocol.
Who cannot join
- Participants who meet any of the following exclusion criteria will not be eligible for the study:
- History of intracranial infection or traumatic brain injury, that is deemed unsuitable for this study based on the judgment by the investigators.
- Severe coronary heart disease, cardiac insufficiency (New York Heart Association Class Ⅲ and Class IV), atrial fibrillation, and other heart diseases that are deemed unsuitable for this study based on the judgment by the investigators.
- 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.
- Severe hematologic disorders, such as myelodysplastic syndrome, aplastic anemia, lymphoma, leukemia, etc.
- Peptic ulcer or obstruction or other diseases that affect the absorption of oral medication.
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- Any neurological disorder that may cause cognitive impairment beyond the impact of AD.
- Any psychiatric diagnosis or neuropsychiatric symptom (such as hallucinations, major depression, or delusions) that may interfere with the participant's study procedure.
- A history of transient ischemic attack (TIA), stroke, or seizure in the 12 months prior to signing ICF.
- The Hachinski Ischemic Index Scale (HIS) at screening > 4 points.
- 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) that are deemed clinically significant by the investigators, 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.).
- The Geriatric Depression Scale (GDS) score at screening ≥ 8 points.
- 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).
- Contraindications with PET scanning, allergies to tracers.
- Brain MRI at screening reveals evidence of other clinically significant lesions, suggesting a possible diagnosis of dementia other than AD.
- Brain MRI at screening reveals the evidence of angioedema, severe white matter damage (Fazekas score = 3), etc., that are deemed unsuitable for this study based on the central imaging assessment; or those with clinically significant space-occupying lesions, aneurysms/vascular malformations, infarctions in critical areas, hydrocephalus, encephalomalacia, etc., that are deemed unsuitable for this study by the investigators.
- Participants with inadequately controlled bleeding disorder (including platelet count < 100×109/L or international normalized ratio [INR] > 1.5), that are deemed clinically significant by the investigators.
- Participants with results of thyroid function tests that fall outside the normal range that are deemed clinically significant by the investigators.
- Laboratory test results for serum vitamin B12 levels below the normal range.
- Positive serological finding for human immunodeficiency virus (HIV), active syphilis, Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody.
- 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.
- Have a known or suspected history of drug or alcohol abuse.
- 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.
- Previous use of prohibited drugs, including disease-modifying drugs (anti-amyloid antibodies, etc.), other formulations of edaravone or drugs containing edaravone.
- Have scheduled major 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.
- Severe vision, hearing, reading, comprehension, or physical dysfunction that prevents the participant from accurately performing neuropsychological tests.
- 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.
- Have been diagnosed with severe active kidney disease, severe renal insufficiency; or glomerular filtration rate < 45 mL/min/1.73m² (Calculated based on the CKD-EPI formula, see Section 17.6 for details).
- Have severe systemic disease and life expectancy is < 2 years.
- 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.
- 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.).
- History of major surgery within 4 weeks prior to the baseline, that is deemed as not yet fully recovered by the investigators.
- 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).
- Participants who have received cholinesterase inhibitors, memantine and/or other symptomatic treatment drugs for AD within 4 weeks prior to randomization and stopped treatment due to safety concerns or other reasons and refuse to or unable to receive it again.
- Female participants who are pregnant, breastfeeding, planning to become pregnant recently, or unwilling to use contraceptive measures.
- Have other conditions that investigator believes the participant is unsuitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Daping Hospital.
Chongqing, Chongqing Municipality, 400042
Yan-Jiang Wang, MD, PhD, +86-023-68757113, wayaja@163.com
About this study
Official title: 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
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
- Being tested
- TTYP01 tables 60mg, TTYP01 tables 90mg, TTYP01 tables 0mg
- Keywords
- AD, Alzheimer's Disease, TTYP01, Placebo-Controlled, Double-Blind, Early Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTYP01 tables 60mgDrug
2 TTYP01 30 mg tablets + 1 placebo tablet BID
TTYP01 tables 90mgDrug
(3 TTYP01 30 mg tablets
TTYP01 tables 0mgDrug
3 placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | 60 mg (2 TTYP01 30 mg tablets + 1 placebo tablet) BID Receives: Drug: TTYP01 tables 60mg |
| High-dose group | Active comparator | 90 mg (3 TTYP01 30 mg tablets) BID Receives: Drug: TTYP01 tables 90mg |
| Placebo group | Placebo comparator | 3 placebo tablets, BID Receives: Drug: TTYP01 tables 0mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) score at Week 78.
Measured: Baseline to Week 78
Number of participants with Adverse events, serious adverse events, adverse events of special interest
Measured: Baseline to Week 78
Secondary outcomes (5)
TTYP01 PK parameter (AUC (0-t,0-24,∞)
Measured: 78 weeks
Change From Baseline in Amyloid Positron Emission Tomography (PET) Using Centiloids at Week 39 and Week 78
Measured: Baseline to Week 39 and Week78
Change from baseline in blood p-tau 217 at week 78.
Measured: baseline to week 78
Changes from baseline in Mini-Mental State Examination (MMSE).
Measured: Week 13, 26, 39, 52, 65, and 78
Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog13) at Week 39 and Week 78.
Measured: baseline to week 39 and week 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start19 Dec 2025
- Primary completion23 Oct 2028 (estimated)
- Study completion23 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Auzone Biological Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252440
- Sponsor's protocol ID
- TTYP01-Ⅱ-AD
- Status last verified
- May 2026
- First submitted
- 14 Nov 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07252440
- Acronym / sponsor ID
- TTYP01-Ⅱ-AD
- Conditions
- AD, Early Alzheimer's Disease
- Keywords
- AD, Alzheimer's Disease, TTYP01, Placebo-Controlled, Double-Blind, Early Alzheimer's disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Auzone Biological Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 23 Oct 2028 (estimated)
- Study completion
- 23 Nov 2028 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Drug: TTYP01 tables 60mg60 mg (2 TTYP01 30 mg tablets + 1 placebo tablet) BID |
| High-dose group | Active comparator | Drug: TTYP01 tables 90mg90 mg (3 TTYP01 30 mg tablets) BID |
| Placebo group | Placebo comparator | Drug: TTYP01 tables 0mg3 placebo tablets, BID |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Age between 55 and 85 years (inclusive, based on the date of signing the informed consent), applicable to all genders.
- Must meet the 2024 NIA-AA revised criteria for diagnosing MCI due to AD or mild AD dementia.
- CDR score: At screening and baseline, the CDR-GS must be 0.5 or 1.0, and the CDR memory score must be0.5 or higher.
- MMSE score: At screening, the MMSE score must be 20 or higher.
- Body mass index (BMI): At screening, BMI must be greater than 17 and less than 35 (inclusive).
Key exclusion criteria (36 listed)
- Participants who meet any of the following exclusion criteria will not be eligible for the study:
- History of intracranial infection or traumatic brain injury, that is deemed unsuitable for this study based on the judgment by the investigators.
- Severe coronary heart disease, cardiac insufficiency (New York Heart Association Class Ⅲ and Class IV), atrial fibrillation, and other heart diseases that are deemed unsuitable for this study based on the judgment by the investigators.
- 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.
- Severe hematologic disorders, such as myelodysplastic syndrome, aplastic anemia, lymphoma, leukemia, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTYP01 tables 60mg2 TTYP01 30 mg tablets + 1 placebo tablet BID | Drug | Low-dose group |
| TTYP01 tables 90mg(3 TTYP01 30 mg tablets | Drug | High-dose group |
| TTYP01 tables 0mg3 placebo tablets | Drug | Placebo group |
Primary outcome
Change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) score at Week 78.
Time frame: Baseline to Week 78
Number of participants with Adverse events, serious adverse events, adverse events of special interest
Time frame: Baseline to Week 78
5 secondary outcomes
TTYP01 PK parameter (AUC (0-t,0-24,∞)
Time frame: 78 weeks
Change From Baseline in Amyloid Positron Emission Tomography (PET) Using Centiloids at Week 39 and Week 78
Time frame: Baseline to Week 39 and Week78
Change from baseline in blood p-tau 217 at week 78.
Time frame: baseline to week 78
Changes from baseline in Mini-Mental State Examination (MMSE).
Time frame: Week 13, 26, 39, 52, 65, and 78
Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog13) at Week 39 and Week 78.
Time frame: baseline to week 39 and week 78
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TTYP01 tables 60mg, TTYP01 tables 90mg and TTYP01 tables 0mg in people with AD and Early Alzheimer's Disease, run by Shanghai Auzone Biological Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan-Jiang Wang, MD, PhD (+86-023-68757113, wayaja@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) score at Week 78. (time frame: Baseline to Week 78). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.