BP42155: Trontinemab in Prodromal/Mild Alzheimer's Disease

• Research type

  Research Study

• Full title

  A PHASE IB/IIA, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-ASCENDING DOSE, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7126209 FOLLOWING INTRAVENOUS INFUSION IN PATIENTS WITH PRODROMAL OR MILD TO MODERATE ALZHEIMER’S DISEASE

• IRAS ID

  1008558

• Contact name

  Ethan Montenegro

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffman-La Roche Ltd.

• Eudract number

  2020-002477-98

• Research summary

  It is estimated that around 50 million people worldwide are living with dementia and that 10 million new cases are diagnosed every year. Alzheimer’s Disease (AD) is the most common form of dementia.
  Trontinemab is an investigational drug which means Health Authorities have not approved it for the treatment of AD or any other disease. It is being developed for the possible treatment of AD. The purpose of this study is to test the safety of trontinemab and to find out what effects, good or bad, trontinemab has on the participant, and on early symptoms of AD.
  A build up of a protein called beta-amyloid plaques occurs in the brain of people with AD. Trontinemab is a anti-amyloid antibody drug combined with a ‘brain shuttle’ which helps it to cross into the brain. Trontinemab works to prevent or decrease the build up of beta-amyloid plaques in the brain. .
  The total number of participants will be about 210 worldwide, approximately 24 from the UK.
  This study has 4 Parts in which increasing doses of Trontinemab will be given to groups of patients to see which dose is the most effective and safe. Part 1 has been completed. In Part 2 participants will receive trontinemab or placebo. In Part 3 all participants will receive trontinemab at two dose levels. Part 4 (“Open Label Extension”) is available for all participants who completed Part 1, 2, or 3 and who qualify. All participants in Part 4 will receive trontinemab for up to 2 years at a dose level that was safe and well tolerated. Placebo will not be given in this study part.
  Participants will be in the study for approx 16 months; a further 30 months if they decide to take part in part 4.
  The study is sponsored by F. Hoffmann-La Roche

• REC name

  London - Central Research Ethics Committee

• REC reference

  23/LO/0810

• Date of REC Opinion

  7 Nov 2023

• REC opinion

  Further Information Favourable Opinion