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

NCT07170150
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Participants
1,060
clinicaltrials.gov
Lead sponsor
Hoffmann-La Roche
clinicaltrials.gov
Start date
2025-11-12
clinicaltrials.gov
Number of sites
147
clinicaltrials.gov

Summary
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).
clinicaltrials.gov
Acronym
TRONTIER 2
clinicaltrials.gov
Short title
A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
clinicaltrials.gov
Official 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)
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2028-02-16
clinicaltrials.gov
First posted
2025-09-12
clinicaltrials.gov
Registry last updated
2026-09-25
clinicaltrials.gov
Primary completion date
2028-02-16
clinicaltrials.gov
Start date
2025-11-12
clinicaltrials.gov

Actual participants
1,060
clinicaltrials.gov
Participants
1,060
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Number of sites
147
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Hoffmann-La Roche
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07170150
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07170150
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: Baseline - Week 72

  1. Change From Baseline Through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)

    Timeframe: 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

    Timeframe: Baseline - Week 72

  3. Change From Baseline Through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)

    Timeframe: Baseline - Week 72

  4. Change From Baseline Through Week 72 in Mini-Mental State Examination (MMSE)

    Timeframe: Baseline - Week 72

  5. Change From Baseline in CDR-SB

    Timeframe: Baseline up to but excluding Week 72

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

    Timeframe: Baseline - Week 72

  7. Percentage of Participants With Adverse Events (AEs)

    Timeframe: Baseline - Week 72

  8. Change from Baseline in C-SSRS (Columbia-Suicide Severity Rating Scale)

    Timeframe: Baseline - Week 72

  9. Percentage of Participants With Amyloid-related Imaging Abnormalities (ARIA) Magnetic Resonance Imaging (MRI) Findings

    Timeframe: Baseline - Week 72

  10. Percentage of Participants With Infusion-related Reactions (IRR)

    Timeframe: Baseline - Week 72

  11. Percentage of Participants With Anti-drug Antibodies (ADAs) to Trontinemab

    Timeframe: Baseline - Week 72

  12. Change From Baseline Through Week 72 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan

    Timeframe: Baseline - Week 72

  13. Change From Baseline to Week 72 in Brain tau Load as Measured by tau PET Scan in a Subset of Participants

    Timeframe: Baseline - Week 72

  14. Change From Baseline Through Week 72 in Cerebrospinal Fluid (CSF) Biomarkers of Disease p-tau181, Neurogranin, Amyloid Beta (Aβ)42, Aβ42/40 in a Subset of Participants

    Timeframe: Baseline - Week 72

  15. Change From Baseline Through Week 72 in Blood Biomarkers p-tau217, Glial Fibrillar Acidic Protein (GFAP), Aβ42, Aβ42/40

    Timeframe: Baseline - Week 72

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
50 Years
Maximum age
90 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Banner Alzheimer?s InstitutePhoenix, United States
  • Sun Valley Research Center, Inc.Imperial, United States
  • Healthy Brain ClinicLong Beach, United States
  • Oakland ClinicalOakland, United States
  • Riverside ClinicalRiverside, United States
  • Cenexel California Neuroscience Research, LLCSherman Oaks, United States
  • Yale UniversityNew Haven, United States
  • JEM Research LLCAtlantis, United States
  • K2 Medical Research-Winter GardenClermont, United States
  • Visionary Investigators Network- Neurology AventuraMiami, United States
  • Charter Research - Winter Park/OrlandoOrlando, United States
  • Conquest Research - Lake NonaOrlando, United States
  • Alzheimer's Research and Treatment CenterStuart, United States
  • CenExel iResearch, LLCDecatur, United States
  • Center for Advanced Research & EducationGainesville, United States
  • Great Lakes Clinical Trials Chicago d/b/a Flourish Research AndersonvilleChicago, United States
  • Adams Clinical BostonBoston, United States
  • Adams Clinical WatertownWatertown, United States
  • Quest Research InstituteFarmington Hills, United States
  • University of Nebraska Medical CenterOmaha, United States
  • The Cognitive and Research Center of New JerseySpringfield, United States
  • IMA Clinical Research - AlbuquerqueAlbuquerque, United States
  • AD-CARE, University of Rochester Medical CenterRochester, United States
  • Summit Research Network Inc.Portland, United States
  • Flourish Research ? PhiladelphiaPlymouth Meeting, United States

And 122 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-518008-33-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)