BP44745 GABriella: Study of RO7269162 in Alzheimer's Disease

• Research type

  Research Study

• Full title

  A PHASE IIa, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE DOSE, MULTICENTER, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND THE EFFECT OF RO7269162 ON AMYLOID AND NON-AMYLOID DISEASE-RELATED BIOMARKERS FOLLOWING DAILY ORAL ADMINISTRATION IN PARTICIPANTS AT RISK FOR OR AT THE PRODROMAL STAGE OF ALZHEIMER’S DISEASE

• IRAS ID

  1008967

• Contact name

  Ethan Montenegro

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche AG

• Research summary

  Alzheimer’s Disease (AD) is a slowly developing disease of the brain that affects memory and other brain functions. It is a disease in which accumulation of protein material called amyloid beta occurs in the brain. Therefore, treatment that helps to prevent or decrease the accumulation of amyloid beta is being tested as possible treatment in AD.

  RO7269162 is an experimental drug that is being developed for the possible treatment of AD. It works by preventing or slowing down the production of the toxic molecules that compose the beta amyloid plaques in the brain. RO7269162 has been tested in healthy participants in another study.

  The purpose of the study is to test RO7269162 at different dose levels to find out what good or bad effects it has on participants, and how it is distributed and eliminated from the body. In this study, the participants will receive either RO7269162 or placebo. A placebo is a pill or medicine that looks like a drug but has no active medicinal ingredients that effect your health.

  The entire study will take approximately 90 weeks to complete for a participant. It includes a screening (up to 12 weeks) and a baseline period (up to 2 weeks), a study treatment period (72 weeks), and a safety follow-up period (4 weeks).

  Approximately 245 people at risk of developing AD or at the prodromal stage of AD will take part in this study worldwide and about 22 people in the UK.

  The study is sponsored by F. Hoffmann- La Roche
  
  Research Summary; v1 dated 03Oct2023

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  24/SW/0017

• Date of REC Opinion

  5 Mar 2024

• REC opinion

  Further Information Favourable Opinion