WN42444: GANTENERUMAB IN THE EARLIEST STAGES OF ALZHEIMER’S DISEASE

• Research type

  Research Study

• Full title

  A PHASE III, MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GANTENERUMAB IN PARTICIPANTS AT RISK FOR OR AT THE EARLIEST STAGES OF ALZHEIMER’S DISEASE

• IRAS ID

  1004248

• Contact name

  Francisca Paisana

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2021-001184-25

• ISRCTN Number

  ISRCTN54460428

• Clinicaltrials.gov Identifier

  NCT05256134

• Research summary

  Study WN42444 investigates whether gantenerumab can prevent or slow the development of symptoms associated with Alzheimer’s disease in individuals who are at risk for or in the earliest stages of Alzheimer’s disease (evidence of amyloid accumulation in the brain, without cognitive deficits), in comparison with placebo.

  This study includes people who are 60-80 years of age (inclusive).

  Participants will be randomly assigned to receive either gantenerumab or placebo. Gantenerumab is a man-made antibody that attaches to amyloid in the brain and mobilizes the immune system to remove it. It is thought that removing brain amyloid may slow down the disease process that underlies Alzheimer’s disease. Gantenerumab and placebo will be administered by injection.
  
  There will be an initial dose escalation period, followed by a maintenance dosing period. If the participant's cognition declines to a point where they are diagnosed with mild cognitive impairment (MCI) or dementia, they will start a post-progression dose escalation period followed by maintenance dosing at the target dose where all participants will receive gantenerumab.

  The study will take approximately 4 years and 9 months to complete. The target number of participants who will take part in this study is 1200 worldwide, with approximately 80 in the UK.

  The study is sponsored by F. Hoffman La Roche.

  Research Summary; V1.0 29Oct2021

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  22/LO/0128

• Date of REC Opinion

  22 Apr 2022

• REC opinion

  Further Information Favourable Opinion