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

NCT07169578
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,101
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Lead sponsor
Hoffmann-La Roche
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Start date
2025-09-17
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Number of sites
142
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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).
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Acronym
TRONTIER 1
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Short title
A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
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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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-02-16
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First posted
2025-09-12
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Registry last updated
2026-09-25
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Primary completion date
2028-02-16
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Start date
2025-09-17
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Actual participants
1,101
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Participants
1,101
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Participant count basis
Actual
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Protocol amendments
0
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Number of sites
142
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Hoffmann-La Roche
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07169578
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ClinicalTrials.gov ID
NCT07169578
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Registry record
Open registry record
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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

  • University of Alabama at BirminghamBirmingham, United States
  • Banner Sun Health Research InstituteSun City, United States
  • Irvine Center for Clinical ResearchIrvine, United States
  • Inglewood ClinicalsLos Angeles, United States
  • UCSF - Memory and Aging CenterSan Francisco, United States
  • Syrentis Clinical ResearchSanta Ana, United States
  • K2 Medical Research - The VillagesLady Lake, United States
  • K2 Medical Research, LLCMaitland, United States
  • Renstar Medical ResearchOcala, United States
  • Axiom Brain Health LLCTampa, United States
  • Charter Research - Lady Lake/The VillagesThe Villages, United States
  • Alzheimer?s Research and Treatment CenterWellington, United States
  • Conquest Research, LLCWinter Park, United States
  • Alzheimer's Research and Treatment Center - ColumbusColumbus, United States
  • Accel Research Sites-NeuroStudiesDecatur, United States
  • Hawaii Pacific NeuroscienceHonolulu, United States
  • RE:Cognition (Chicago)Chicago, United States
  • Tandem Clinical Research, LLCMarrero, United States
  • Brigham and Womens HospitalBoston, United States
  • Boston Center for MemoryNewton, United States
  • Washington University School of MedicineSt Louis, United States
  • The Cognitive and Research Center of New JerseyRidgewood, United States
  • Basil ClinicalLaurelton, United States
  • Weill Cornell Medical CollegeNew York, United States
  • Adams Clinical HarlemNew York, United States

And 117 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-518006-40-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)