Clinical Trials List
Protocol NumberWN45443
Active
2025-09-15 - 2030-12-31
Recruiting8
ICD-10G30.0
Alzheimer's disease with early onset
ICD-10G30.1
Alzheimer's disease with late onset
ICD-10G30.8
Other Alzheimer's disease
ICD-10G30.9
Alzheimer's disease, unspecified
ICD-9331.0
Alzheimer's disease
A phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial investigating the efficacy and safety of TRONTINEMAB in patients with early symptomatic Alzheimer's disease (mild cognitive impairment to mild dementia caused by Alzheimer's disease).
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Trial Applicant
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Sponsor
Roche Pharmaceuticals Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/16
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yu-Wan Yang Division of Neurology
- Yi-Ting Hsu Division of Neurology
- Kuan-Fei Chen Division of Neurology
- Ching-Hua Lu Lu Division of Neurology
- 王奕醫師 Division of Ophthalmology
- 林欽揚醫師 Division of Neurology
- 林馥郁醫師 Division of Neurology
- 程康倫醫師 Division of Others
- 楊依倩醫師 Division of Neurology
- 廖炯為醫師 Division of Nuclear Medicine
- 凃敏謙醫師 Division of Neurology
- 涂敏謙醫師 Division of Neurology
- 盧韻如醫師 Division of Neurology
- 黃上芝醫師 Division of Neurology
- 賴泓茵醫師 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- MEI-CHUAN CHOU Division of Neurology
- PING SONG CHOU Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Changes in CDR-SB from the base period to week 72
Objectives
The aim of this trial was to evaluate the efficacy and safety of trontinemab in participants with early-stage symptomatic Alzheimer's disease (AD) ranging from mild cognitive impairment [MCI] to mild dementia. While anti-β-amyloid (Aβ) monoclonal antibodies (mAbs) with the potential to modulate disease progression have recently been introduced, there is still a need for treatments that can improve the benefit-risk profile and significantly and rapidly reduce Aβ levels. A major obstacle in developing innovative anti-Aβ mAbs is how to deliver the drug to the brain across the blood-brain barrier. Trontinemab is a 2+1 bispecific mAb construct combining the anti-Aβ antibody gantenerumab with the Brainshuttle™ unit. It binds to human transferrin receptor 1 expressed on the surface of brain microvascular endothelial cells, enabling active entry into the brain and significantly increasing CNS exposure.
Test Drug
trontinemab
Active Ingredient
Trontinemab
Dosage Form
Injectable solution
Dosage
50 mg/2 mL
Endpoints
Changes in CDR-SB from the base period to week 72
Inclution Criteria
To be eligible for this trial, potential participants must meet all of the following criteria:
• Participants must provide written consent and sign a participant consent form (co-signed by the participant's legal representative, as required by local regulations, guidelines, and an independent ethics committee (EC) or institutional review board (IRB)).
• Be between 50 and 90 years of age at the time of signing the participant consent form.
• Be weigh 150 kg or less.
• Be fluent in the language used for testing at the trial center.
• Be willing and able to complete all aspects of the trial during the trial period (including magnetic resonance imaging (MRI), clinical genotyping, and positron emission tomography (PET) or cerebrospinal fluid (CSF), if applicable). Participants should be able to complete the assessment alone or with the assistance of a trial partner.
• The trial administrator determines that the participant has sufficient vision and hearing to proceed with neuropsychological testing (glasses and hearing aids are permitted).
• Evidence of AD pathological progression is confirmed by visually interpreting amyloid PET scan results from the core/central PET laboratory. If amyloid PET is not possible, the CSF tau181/Aβ42 ratio can be used as an alternative.
• Possible Alzheimer's disease (AD) dementia (meeting the National Institute on Aging-Alzheimer’s Association (NIA-AA) core clinical criteria for possible AD dementia) or mild cognitive impairment (MCI) due to AD (meeting the NIA-AA core clinical criteria for mild cognitive impairment (MCI) due to AD), also known as clinical stage 3 or 4 of Alzheimer's clinical syndrome (according to the NIA-AA research framework).
• At screening, a Mini-Mental State Examination (MMSE) score of 22 and a Clinical Dementia Rating (CDR-GS) global score of 0.5 or 1.0.
• If the participant and/or information provider report a history of cognitive decline as documented in the diagnostic verification form, which gradually developed and worsened within one year prior to screening, an Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or below.
• I agree not to donate blood or blood products for transfusion during the trial and for one year after the last dose of the investigational drug.
• I agree to comply with the contraceptive requirements described below.
(For detailed inclusion criteria, please refer to the trial plan for this case.)
• Participants must provide written consent and sign a participant consent form (co-signed by the participant's legal representative, as required by local regulations, guidelines, and an independent ethics committee (EC) or institutional review board (IRB)).
• Be between 50 and 90 years of age at the time of signing the participant consent form.
• Be weigh 150 kg or less.
• Be fluent in the language used for testing at the trial center.
• Be willing and able to complete all aspects of the trial during the trial period (including magnetic resonance imaging (MRI), clinical genotyping, and positron emission tomography (PET) or cerebrospinal fluid (CSF), if applicable). Participants should be able to complete the assessment alone or with the assistance of a trial partner.
• The trial administrator determines that the participant has sufficient vision and hearing to proceed with neuropsychological testing (glasses and hearing aids are permitted).
• Evidence of AD pathological progression is confirmed by visually interpreting amyloid PET scan results from the core/central PET laboratory. If amyloid PET is not possible, the CSF tau181/Aβ42 ratio can be used as an alternative.
• Possible Alzheimer's disease (AD) dementia (meeting the National Institute on Aging-Alzheimer’s Association (NIA-AA) core clinical criteria for possible AD dementia) or mild cognitive impairment (MCI) due to AD (meeting the NIA-AA core clinical criteria for mild cognitive impairment (MCI) due to AD), also known as clinical stage 3 or 4 of Alzheimer's clinical syndrome (according to the NIA-AA research framework).
• At screening, a Mini-Mental State Examination (MMSE) score of 22 and a Clinical Dementia Rating (CDR-GS) global score of 0.5 or 1.0.
• If the participant and/or information provider report a history of cognitive decline as documented in the diagnostic verification form, which gradually developed and worsened within one year prior to screening, an Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or below.
• I agree not to donate blood or blood products for transfusion during the trial and for one year after the last dose of the investigational drug.
• I agree to comply with the contraceptive requirements described below.
(For detailed inclusion criteria, please refer to the trial plan for this case.)
Exclusion Criteria
Potential participants will be excluded from this trial if they meet any of the following criteria: Medical conditions related to the central nervous system (CNS) Participants meeting any of the following CNS-related conditions will not be eligible for the trial:
• Evidence of any disease other than Alzheimer's disease that may affect cognition, including but not limited to frontotemporal dementia, Lewy body dementia, vascular dementia, Parkinson's disease, corticobasal ganglia syndrome, Cujjad disease, progressive superior ophthalmoplegia, frontotemporal lobe degeneration (other than frontotemporal dementia), Huntington's disease, normobaric hydrocephalus, epilepsy, delirium, or hypoxia
• Past or present clinically significant cerebrovascular disease (e.g., intracranial or cerebral vascular malformation, aneurysm, massive intracranial hemorrhage). Small, individual developmental venous abnormalities will be assessed by the trial administrator.
• Past history of severe, clinically significant (persistent neurological deficits or structural brain injury) CNS trauma.
• Past or current clinically significant intracranial mass (e.g., glioma, meningioma). For meningiomas < 10 mm or arachnoid cysts, the trial administrator will make the determination.
• History of schizophrenia, affective schizophrenia, major depressive disorder, or bipolar disorder.
• A history of major depressive disorder is acceptable if the participant has been remission-free for the past year and is considered to have remitted, or if their depression is controlled through treatment.
• Past or present history of any stroke with clinical symptoms within the past 12 months, or a history of an acute event deemed by the trial administrator to be consistent with transient ischemic attack within the past 12 months.
• Trial administrator believes there is a risk of suicide.
• Substance abuse disorder (nicotine use permitted) within the 12 months prior to screening.
Imaging-Related Criteria
Participants meeting any of the following imaging criteria will not be eligible for the trial:
• Any of the following MRI evidences at screening, according to the Central Interpretation Center for Magnetic Resonance Imaging (MRI):
-> Two small interstitial or other (including cerebellar) infarcts
- Any regional infarction > 10 mm
- Any white matter lesion with an overall Fazekas score of 3, and at least one confluent lesion of 20 mm in any direction on fluid-attenuated inversion recovery (FLAIR) sequences
- Total number of microbleeds on MRI > 4
- Current history of any leptomeningeal hemosiderinosis
- MRI The test showed any other significant brain abnormalities, including amyloid-related imaging abnormality edema/effusion (ARIA-E).
- Intolerance to MRI procedures or contraindications to MRI, including but not limited to pacemakers, aneurysm clips, artificial heart valves, implanted hearing aids, or foreign metallic substances in the eyes, skin, or body that preclude MRI scanning, or any other clinical history or finding determined by the trial administrator that could potentially cause harm due to concomitant MRI.
(For detailed exclusion criteria, please refer to the trial proposal for this case.)
• Evidence of any disease other than Alzheimer's disease that may affect cognition, including but not limited to frontotemporal dementia, Lewy body dementia, vascular dementia, Parkinson's disease, corticobasal ganglia syndrome, Cujjad disease, progressive superior ophthalmoplegia, frontotemporal lobe degeneration (other than frontotemporal dementia), Huntington's disease, normobaric hydrocephalus, epilepsy, delirium, or hypoxia
• Past or present clinically significant cerebrovascular disease (e.g., intracranial or cerebral vascular malformation, aneurysm, massive intracranial hemorrhage). Small, individual developmental venous abnormalities will be assessed by the trial administrator.
• Past history of severe, clinically significant (persistent neurological deficits or structural brain injury) CNS trauma.
• Past or current clinically significant intracranial mass (e.g., glioma, meningioma). For meningiomas < 10 mm or arachnoid cysts, the trial administrator will make the determination.
• History of schizophrenia, affective schizophrenia, major depressive disorder, or bipolar disorder.
• A history of major depressive disorder is acceptable if the participant has been remission-free for the past year and is considered to have remitted, or if their depression is controlled through treatment.
• Past or present history of any stroke with clinical symptoms within the past 12 months, or a history of an acute event deemed by the trial administrator to be consistent with transient ischemic attack within the past 12 months.
• Trial administrator believes there is a risk of suicide.
• Substance abuse disorder (nicotine use permitted) within the 12 months prior to screening.
Imaging-Related Criteria
Participants meeting any of the following imaging criteria will not be eligible for the trial:
• Any of the following MRI evidences at screening, according to the Central Interpretation Center for Magnetic Resonance Imaging (MRI):
-> Two small interstitial or other (including cerebellar) infarcts
- Any regional infarction > 10 mm
- Any white matter lesion with an overall Fazekas score of 3, and at least one confluent lesion of 20 mm in any direction on fluid-attenuated inversion recovery (FLAIR) sequences
- Total number of microbleeds on MRI > 4
- Current history of any leptomeningeal hemosiderinosis
- MRI The test showed any other significant brain abnormalities, including amyloid-related imaging abnormality edema/effusion (ARIA-E).
- Intolerance to MRI procedures or contraindications to MRI, including but not limited to pacemakers, aneurysm clips, artificial heart valves, implanted hearing aids, or foreign metallic substances in the eyes, skin, or body that preclude MRI scanning, or any other clinical history or finding determined by the trial administrator that could potentially cause harm due to concomitant MRI.
(For detailed exclusion criteria, please refer to the trial proposal for this case.)
The Estimated Number of Participants
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Taiwan
90 participants
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Global
800 participants
