Skip To Main Content

Search

For optimal search results, please limit to 2 product keywords

If you are searching for information related to a product:

  • For optimal results, please enter at least 2 search terms in addition to product name
  • Example: [product name] [search term] [search term]
  • Example: Product + clinical trials
  • For an exact match, please include search terms in double quotations. For example: "Elevatum"

    Please enter search terms.

    Phase III: Trontinemab in AD (TRONTIER 1)

    Clinical Trial Overview

    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)

    Objective

    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).

    AD=Alzheimer’s disease; MCI=mild cognitive impairment

    Primary Endpoints

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

    Secondary Endpoints

    • Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)
    • Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score
    • Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)
    • Change from baseline through Week 72 in Mini-Mental State Examination (MMSE)
    • Change from baseline in CDR-SB
    • Time to increase in Clinical Dementia Rating, Global Score (CDR-GS)
    • Percentage of participants with adverse events (AEs)
    • Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings
    • Percentage of participants with infusion-related reactions (IRR)
    • Percentage of participants with anti-drug antibodies (ADAs) to trontinemab
    • Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan
    • Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants
    • Change from baseline through Week 72 in cerebrospinal fluid (CSF) biomarkers of disease p-tau181, neurogranin, Aβ42 in a subset of participants
    • Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP)

    ADAs=anti-drug antibodies; ADAS-Cog-13=Alzheimer's Disease Assessment Scale-Cognition 13; ADCS-ADL=Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory; AEs=adverse events; ARIA=amyloid-related imaging abnormalities; CDR-GS=Clinical Dementia Rating, Global Score; CDR-SB=Clinical Dementia Rating, Sum of Boxes; CSF=cerebrospinal fluid; GFAP=glial fibrillar acidic protein; iADRS=Integrated Alzheimer's Disease Rating Scale; IRR=infusion-related reactions; MMSE=Mini-Mental State Examination; MRI=magnetic resonance imaging; PET=positron emission tomography

    Trontinemab (RG6102)

    Modality: Brainshuttle™ bispecific 2+1 amyloid-beta targeting monoclonal antibody

    View Details
    View Related Trials

    QUICK LINKS

    Molecule
    Clinical Trial Overview
    Inclusion and Exclusion Criteria
    Enrollment and Resources
    Related Trials
    Contact an MSL
    View on ClinicalTrials.gov

    Inclusion and Exclusion Criteria

    Key Inclusion Criteria Key Exclusion 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 lower
    • Availability of a "study partner" as defined by the protocol
    • 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

    CNS=central nervous system; RBANS DMI=Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index

    Enrollment & Resources

    Enrollment

    For more information on eligibility criteria, view the study or reach out to our team.

    General icon

    Web

    ClinicalTrials.gov
    Identifier: NCT07169578

    Visit Site
    Call icon

    Phone

    1-888-662-6728
    (US and Canada)

    Call Us
    Email icon

    Email

    [email protected]

    Email Us

    Clinical Trial Site Locations

    Clinical Trial Site Locations

    For more information on recruitment status, or where the study is being conducted

    Visit ClinicalTrials.gov

    Patient Resources

    Genentech offers a place for patients, relatives, and caregivers to learn more about clinical trials.

    Visit Site

    Information is consistent with ClinicalTrials.gov as of February 2, 2026. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

    Looking for more information?

    Reach out to a Genentech Medical Science Liaison near you, or connect with the contact center.

    Connect with an MSL
    Submit a Request

    Call the Trial Information Support Team: 1-888-662-6728 Hours: Monday-Friday, 5am-5pm PT

    TOP

    • AD
      Alzheimer’s disease

    • ADAS-Cog-13
      Alzheimer's Disease Assessment Scale-Cognition 13

    • ADAs
      Anti-drug antibodies

    • ADCS-ADL
      Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory

    • AEs
      Adverse events

    • ARIA
      Amyloid-related imaging abnormalities

    • CDR-GS
      Clinical Dementia Rating, Global Score

    • CDR-SB
      Clinical Dementia Rating, Sum of Boxes

    • CNS
      Central nervous system

    • CSF
      Cerebrospinal fluid

    • GFAP
      Glial fibrillar acidic protein

    • iADRS
      Integrated Alzheimer's Disease Rating Scale

    • IRR
      Infusion-related reactions

    • MCI
      Mild cognitive impairment

    • MMSE
      Mini-Mental State Examination

    • MRI
      Magnetic resonance imaging

    • PET
      Positron emission tomography

    • RBANS DMI
      Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index