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NCT Number: NCT07169578

A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

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).

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Key information

Conditions

Alzheimers Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Italiano, CABA, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trontinemab

Drug

Participants will receive IV trontinemab.

Other names: RO7126209

Placebo

Other

Participants will receive IV placebo.

Primary outcomes

  1. Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)

    Time frame: Baseline - Week 72

Secondary outcomes

  1. Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)

    Time frame: Baseline - Week 72

  2. Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score

    Time frame: Baseline - Week 72

  3. Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)

    Time frame: Baseline - Week 72

  4. Change from baseline through Week 72 in Mini-Mental State Examination (MMSE)

    Time frame: Baseline - Week 72

  5. Change from baseline in CDR-SB

    Time frame: Baseline up to but excluding Week 72

  6. Time to increase in Clinical Dementia Rating, Global Score (CDR-GS)

    Time frame: Baseline - Week 72

  7. Percentage of participants with adverse events (AEs)

    Time frame: Baseline - Week 72

  8. Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings

    Time frame: Baseline - Week 72

  9. Percentage of participants with infusion-related reactions (IRR)

    Time frame: Baseline - Week 72

  10. Percentage of participants with anti-drug antibodies (ADAs) to trontinemab

    Time frame: Baseline - Week 72

  11. Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan

    Time frame: Baseline - Week 72

  12. Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants

    Time frame: Baseline - Week 72

  13. Change from baseline through Week 72 in cerebrospinal fluid (CSF) biomarkers of disease p-tau181, neurogranin, Aβ42 in a subset of participants

    Time frame: Baseline - Week 72

  14. Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP)

    Time frame: Baseline - Week 72

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: WN45443 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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)

Acronym: TRONTIER 1

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 12, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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