Clinical Trials List
Protocol NumberWN46072
NCT Number(ClinicalTrials.gov Identfier)NCT07717411
Not yet recruiting
2026-08-01 - 2035-12-31
Phase III
Not yet recruiting1
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/25
Investigators and Locations
Co-Principal Investigator
- Li-Kai Huang Division of Neurology
- Shu-Ping Chao Division of Neurology
- 章筱伶 Division of Ophthalmology
Co-Principal Investigator
- Kuan-Fei Chen Division of Neurology
- Yi-Ting Hsu Division of Neurology
- Ching-Hua Lu Lu Division of Neurology
- 凃敏謙 Division of Neurology
- Yi-Chien Yang Division of Neurology
- 盧韻如 Division of Neurology
- Sheng-Ta Tsai Division of Neurology
- 廖炯為 Division of Nuclear Medicine
- 程康倫 Division of Radiology
- 賴泓茵 Division of Ophthalmology
Principal Investigator
Ming-Chyi Pai
Co-Principal Investigator
- Wei-Pin Hong Division of Neurology
- 張維紘 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Alzheimer's Disease
Objectives
本試驗將評估trontinemab 對具有阿茲海默症(AD)病理生物標記證據，但無認知或功能障礙(相當於阿茲海默症協會[AA]指引修訂版中的第1-2 期)，且因AD 導致症狀性AD(輕度認知障礙[MCI])或因AD 導致失智症(相當於AA 指引修訂版中的第3-6 期)風險的參與者之療效和安全性。
Test Drug
注射液劑
Active Ingredient
Trontinemab
Dosage Form
27D
Dosage
50 mg/ 2 mL
Endpoints
評估trontinemab 相較於安慰劑，對臨床惡化的療效
Inclution Criteria
Inclusion Criteria:
Body weight of 150 kg or less
Willingness and ability to complete all aspects of the study for the duration of the study
Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
Cognitively and functionally unimpaired as defined by the protocol
Availability of a study partner as defined by the protocol
A plasma pTau217 level consistent with a high likelihood of future clinical progression
Body weight of 150 kg or less
Willingness and ability to complete all aspects of the study for the duration of the study
Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
Cognitively and functionally unimpaired as defined by the protocol
Availability of a study partner as defined by the protocol
A plasma pTau217 level consistent with a high likelihood of future clinical progression
Exclusion Criteria
Exclusion Criteria:
Any evidence of a condition other than AD that may affect cognition, including, but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson disease, corticobasal syndrome, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal lobar degeneration (other than frontotemporal dementia), Huntington disease, normal pressure hydrocephalus, seizure disorder, delirium, or hypoxia
Mild cognitive impairment (MCI; may be referred to as prodromal AD), or any form of dementia
History or presence of clinically significant cerebrovascular disease
History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma
History or presence of clinically significant intracranial mass
History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 12 months of an acute event that is consistent, in the opinion of the PI, with a transient ischemic attack
At risk for suicide in the opinion of the investigator
Substance abuse disorder within 12 months prior to screening (nicotine use is allowed)
Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments
Uncontrolled hypertension
Impaired hepatic function
History or presence of any clinically significant hematological diseases
Diagnosis of a wet age-related macular degeneration (AMD)
Abnormal thyroid function
Abnormally low serum levels of folic acid or vitamin B12 deficiency that are judged to be clinically significant and/or may impact cognition as per the investigator's judgment
Current HIV, hepatitis B, or hepatitis C infection that has not been adequately treated in the opinion of the investigator
History of malignancy
Any previous administration of active immunotherapy (vaccine) that is being evaluated to prevent or postpone cognitive decline
Any previous or current use of passive immunotherapy (immunoglobulin) or other long-acting biologic agent that is approved or under evaluation or has been evaluated to prevent or postpone cognitive decline
Any other investigational treatment within 5 half-lives or 4 months prior to screening, whichever is longer
Intravenous (IV) or subcutaneous immunoglobulin therapy within 5 half-lives or 4 months prior to baseline whichever is longer
Anticoagulation medications at screening and there should be no plans to initiate any prior to or after randomization
Any treatment with cholinesterase inhibitors
Antipsychotic or neuroleptic medications within 3 months of screening, except as brief treatment for a non-psychiatric indication
Individuals with chronic use of opiates or opioids, benzodiazepines, barbiturates, or hypnotics, antidepressants or medication to treat anxiety should be on a stable dose for at least 8 weeks before baseline
Currently enrolled in an interventional study including those requiring investigational medicinal product (IMP) or involving any type of medical research that may interfere with study cognitive assessments
Residence in a skilled nursing facility such as a convalescent home or long-term care facility
Any evidence of a condition other than AD that may affect cognition, including, but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson disease, corticobasal syndrome, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal lobar degeneration (other than frontotemporal dementia), Huntington disease, normal pressure hydrocephalus, seizure disorder, delirium, or hypoxia
Mild cognitive impairment (MCI; may be referred to as prodromal AD), or any form of dementia
History or presence of clinically significant cerebrovascular disease
History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma
History or presence of clinically significant intracranial mass
History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 12 months of an acute event that is consistent, in the opinion of the PI, with a transient ischemic attack
At risk for suicide in the opinion of the investigator
Substance abuse disorder within 12 months prior to screening (nicotine use is allowed)
Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments
Uncontrolled hypertension
Impaired hepatic function
History or presence of any clinically significant hematological diseases
Diagnosis of a wet age-related macular degeneration (AMD)
Abnormal thyroid function
Abnormally low serum levels of folic acid or vitamin B12 deficiency that are judged to be clinically significant and/or may impact cognition as per the investigator's judgment
Current HIV, hepatitis B, or hepatitis C infection that has not been adequately treated in the opinion of the investigator
History of malignancy
Any previous administration of active immunotherapy (vaccine) that is being evaluated to prevent or postpone cognitive decline
Any previous or current use of passive immunotherapy (immunoglobulin) or other long-acting biologic agent that is approved or under evaluation or has been evaluated to prevent or postpone cognitive decline
Any other investigational treatment within 5 half-lives or 4 months prior to screening, whichever is longer
Intravenous (IV) or subcutaneous immunoglobulin therapy within 5 half-lives or 4 months prior to baseline whichever is longer
Anticoagulation medications at screening and there should be no plans to initiate any prior to or after randomization
Any treatment with cholinesterase inhibitors
Antipsychotic or neuroleptic medications within 3 months of screening, except as brief treatment for a non-psychiatric indication
Individuals with chronic use of opiates or opioids, benzodiazepines, barbiturates, or hypnotics, antidepressants or medication to treat anxiety should be on a stable dose for at least 8 weeks before baseline
Currently enrolled in an interventional study including those requiring investigational medicinal product (IMP) or involving any type of medical research that may interfere with study cognitive assessments
Residence in a skilled nursing facility such as a convalescent home or long-term care facility
The Estimated Number of Participants
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Taiwan
90 participants
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Global
1600 participants
