A Study to Evaluate the Efficacy and Safety of TTYP01 Tablets in Early Symptomatic Alzheimer's Disease

NCT07252440 | Recruiting Phase 2

• 1 other identifier: TTYP01-Ⅱ-AD
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AD; Early Alzheimer's Disease

Keywords

AD; Alzheimer's Disease; TTYP01; Placebo-Controlled; Double-Blind; Early Alzheimer's disease

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) score at Week 78.

  Baseline to Week 78

• Number of participants with Adverse events, serious adverse events, adverse events of special interest

  Baseline to Week 78

Secondary Outcomes (5)

• TTYP01 PK parameter (AUC (0-t,0-24,∞)

  78 weeks

• Change From Baseline in Amyloid Positron Emission Tomography (PET) Using Centiloids at Week 39 and Week 78

  Baseline to Week 39 and Week78

• Change from baseline in blood p-tau 217 at week 78.

  baseline to week 78

• Changes from baseline in Mini-Mental State Examination (MMSE).

  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.

  baseline to week 39 and week 78

Other Outcomes (6)

• To explore the exposure-clinical effect relationship of TTYP01 Tablets in treating early symptomatic AD.

  week78

• To explore the exposure-effect relationship of TTYP01 Tablets on cerebral amyloid plaque deposition, and MRI brain volume.

  week39 ,week78

• To assess the effect of TTYP01 vs. placebo on clinical progression, behavioral, neuropsychiatric symptom and study partner burden in early symptomatic AD patients.

  Week 13, 26, 39, 52, 65, and 78.

Study Arms (3)

Low-dose group

EXPERIMENTAL

60 mg (2 TTYP01 30 mg tablets + 1 placebo tablet) BID

Drug: TTYP01 tables 60mg

High-dose group

ACTIVE COMPARATOR

90 mg (3 TTYP01 30 mg tablets) BID

Drug: TTYP01 tables 90mg

Placebo group

PLACEBO COMPARATOR

3 placebo tablets, BID

Drug: TTYP01 tables 0mg

Interventions

TTYP01 tables 60mg DRUG

2 TTYP01 30 mg tablets + 1 placebo tablet BID

Low-dose group

TTYP01 tables 90mg DRUG

(3 TTYP01 30 mg tablets

High-dose group

TTYP01 tables 0mg DRUG

3 placebo tablets

Placebo group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all the following criteria to be eligible for this study:
• Age between 60 and 85 years (inclusive, based on the date of signing the informed consent), applicable to all genders.
• Must meet the 2024 Alzheimer's Association (AA) Workgroup revised criteria for diagnosing MCI due to AD or mild AD dementia.
• 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.
• MMSE score: At screening, the MMSE score must be 22 or higher.
• Body mass index (BMI): At screening, BMI must be greater than 17 and less than 35 (inclusive).
• 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 (For participants with evidence suggesting Aβ-PET positivity, absence blood p-tau 217 determination is not considered a protocol deviation.).
• 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 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.
• 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.

You may not qualify if:

• History of intracranial infection or traumatic brain injury.
• 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.
• 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.
• 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.
• 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) 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.

Sponsors & Collaborators

• Shanghai Auzone Biological Technology Co., Ltd.: lead

Study Sites (1)

Daping Hospital.

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Yan-Jiang Wang, MD, PhD

CONTACT

+86-023-68757113; wayaja@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 26, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): October 23, 2028
• Study Completion (Estimated): November 23, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)