WP45722 Master Screening Study for Early Stage Alzheimer's studies

• Research type

  Research Study

• Full title

  MASTER SCREENING STUDY TO DETERMINE INDIVIDUALS WITH POTENTIAL TRIAL ELIGIBILITY FOR ALZHEIMER’S DISEASE STUDIES AS ASSESSED BY BIOMARKER STATUS AND COGNITION

• IRAS ID

  349933

• Contact name

  Head EU/ International Regulatory Affairs,

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Duration of Study in the UK

  10 years, 0 months, 30 days

• Research summary

  Study WP45722 is a global, multicentre, master pre-screening study. No investigational medicinal product (IMP) is administered in this study. The overarching structure of this study is a flexible master pre-screening process that will assess participants’ potential eligibility for a Roche interventional Alzheimer's Disease (AD) study based on a cognitive test and plasma levels of pTau217. Initially, this pre-screening process is to support earlier and easier detection of people with early symptomatic AD (minimally symptomatic or mild cognitive impairment (MCI) or mild dementia due to AD, inclusive of stages 2-4).
  Demographics as well as medical and medication history will be collected for all screened participants. Participants who meet eligibility criteria will undergo a cognitive test. Blood samples for haematology, serum chemistry, and for pTau217 will be collected from all enrolled participants and then potential eligibility for a Roche interventional AD study will be established based on predefined thresholds, defined in a dedicated memo, from the cognitive test and the pTau217 results. The Principal Investigators (PIs) will be informed if their participants meet the thresholds or not for potential eligibility, for all participants whose results are available.
  Participants with a potentially eligible profile, based on the cognitive and biomarker results, can then be referred for screening in an appropriate Roche interventional AD study which is open for recruitment.
  The total duration of study participation for a participant is expected to be up to 15 days.
  The aim is to recruit 13000 participants globally with around 800 from the UK.
  The study will last approximately 10 years from first patient screened to end of study.
  The study is sponsored by F. Hoffmann- La Roche
  Research Summary; Version 1 dated 20-Mar-2025

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  25/NW/0114

• Date of REC Opinion

  1 May 2025

• REC opinion

  Unfavourable Opinion