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Clinical Trials List

Protocol NumberWN45443
Active

2025-09-15 - 2030-12-31

Phase III

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 EFFICACY AND SAFETY STUDY OF TRONTINEMAB IN PARTICIPANTS WITH EARLY SYMPTOMATIC ALZHEIMER’S DISEASE (MCI TO MILD DEMENTIA DUE TO AD)

  • Trial Applicant

  • Sponsor

    F. Hoffmann-La Roche Ltd

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator TA-FU CHEN Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張瓊之 Division of Neurology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 傅中玲醫師 Division of Neurology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳怡君 Division of Neurology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jui-Cheng Chen Division of Neurology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chiou-Lian Lai Division of Neurology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 胡朝榮醫師
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator WEI-JU LEE Division of Neurology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

EARLY SYMPTOMATIC ALZHEIMER’S DISEASE (MCI TO MILD DEMENTIA DUE TO AD)

Objectives

To evaluate the effect of trontinemab on clinical progression at Week 72 as compared with placebo

Test Drug

injection

Active Ingredient

Trontinemab

Dosage Form

27D

Dosage

50 mg/2 mL

Endpoints

Change from baseline to Week 72 in CDR-SB

Inclution Criteria

Potential participants are eligible to be included in the study only if all of the following criteria apply:
 Ability to provide written consent with an Informed Consent Form signed by the participant (co-signed by the participant’s legally authorized representative, if required by the local regulations, guidelines, and independent Ethics Committee [EC] or Institutional Review Board [IRB])
 Age  50 years and  90 years at the time of signing Informed Consent Form|
 Body weight of 150 kg or less
 Fluency in the language of the tests used at the study site
 Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner
 Adequate visual and auditory acuity, in the investigator’s judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
 Evidence of AD pathological process, as confirmed on amyloid PET scan visual read by the core/central PET laboratory. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available.
 Probable AD dementia (consistent with NIA-AA core clinical criteria for probable AD dementia) (McKhann et al. 2011) or MCI due to AD (consistent with the NIA-AA core clinical criteria for MCI due to AD) (Albert et al. 2011), also known as an Alzheimer’s clinical syndrome clinical Stage 3 or Stage 4 (according to the NIA-AA research framework, Jack et al. 2018 and revised AA criteria, Jack et al. 2024).
 Screening MMSE score  22 and CDR-GS of 0.5 or 1.0
 Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening as documented in the Diagnosis Verification Form
 An RBANS DMI score of 85 or lower
 Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
 Agrees to adhere to the contraception requirements as described in Section 5.4

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’s disease, corticobasal syndrome, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal lobar degeneration (other than frontotemporal dementia), Huntington’s disease, normal pressure hydrocephalus, seizure disorder, delirium, or hypoxia
 History or presence of clinically significant cerebrovascular disease (e.g., intracranial or cerebral vascular malformations, aneurysm, intracranial macrohemorrhage). In case of a small, isolated developmental venous anomaly PI’s judgement applies.
 History of severe, clinically significant (persistent neurologic deficit or structural brain damage) CNS trauma
 History or presence of clinically significant intracranial mass (e.g., glioma, meningioma). For meningiomas or arachnoid cysts  10 mm, PI’s judgement applies.
 History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    800 participants

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