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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)

Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Sep 2025

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At a glance

  • Drugs Trontinemab (Primary)
  • Indications Alzheimer's disease
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms TRONTIER-1
  • Sponsors Roche

Most Recent Events

  • 12 Sep 2025 Status changed from planning to recruiting.
  • 27 Jul 2025 According to a Genentech media release, Roche's Elecsys pTau217 is a blood-based biomarker test for rule-in and rule-out diagnosis of Alzheimer's amyloid pathology which has received Breakthrough Device Designation from USFDA will also be utilized in Roche's TRONTIER studies.
  • 27 Jul 2025 According to a Genentech media release, design of the Phase III TRONTIER 1 and 2 studies will be presented at the Alzheimer's Association International Conference (AAIC) in Toronto, Canada (July 27-30).

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