A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (TRONTIER 1)

Roche

Status and phase: Enrolling; Phase 3

Conditions: Alzheimers Disease

Treatments: Drug: Trontinemab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07169578

WN45443

2024-518006-40-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment [MCI] to mild dementia due to AD).

Enrollment: 800 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available
• Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4
• 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
• A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order
• Availability of a "study partner" as defined by the protocol

Exclusion criteria

• Any evidence of a condition other than AD that may affect cognition
• 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
• MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI
• 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
• History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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800 participants in 2 patient groups, including a placebo group

Trontinemab

Experimental group

Description:

Participants will receive intravenous (IV) trontinemab.

Treatment:

Drug: Trontinemab

Placebo

Placebo Comparator group

Description:

Participants will receive IV placebo.

Treatment:

Other: Placebo