WN45443: Trontinemab for Early Alzheimer's TRONTIER 1

• Research type

  Research Study

• Full 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)

• IRAS ID

  1012307

• Contact name

  N/A N/A

• Contact email

  medinfo.uk@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche AG

• Research summary

  This is a study to compare how well trontinemab works against a placebo in people with early symptoms of Alzheimer’s disease (AD). Trontinemab is designed to remove amyloid plaques from the brain and is being developed to treat early symptoms of AD. Plaques are the main reasons that brain cells are damaged.
  Males and females of 50 - 90 years of age with AD can take part in the study if they have mild memory or thinking problems or if these problems have started to affect their work or daily activities. Also they must have confirmed presence of amyloid plaques in their brain.
  Initially, eligible participants will receive either trontinemab or placebo via intravenous infusion every 4 weeks (the induction period). After the induction period, they will continue receiving trontinemab or placebo less frequently for the remainder of the study. This will involve at least 15 visits, some which may last up to 10 hours (which can be split over two days), others up to 6 hours, and some others will be less. Each participant’s time in the study will be about 80 weeks.
  800 patients will be recruited globally with 40 in the UK, over 10 sites

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  25/EM/0161

• Date of REC Opinion

  26 Aug 2025

• REC opinion

  Further Information Favourable Opinion