Prospective cutoff establishment and pivotal clinical study of EAPP

• Research type

  Research Study

• Full title

  A multicenter, prospective, non-interventional study to determine the cutoff and clinical performance of the Elecsys® Amyloid Plasma Panel and its component assays

• IRAS ID

  326591

• Contact name

  Craig William Ritchie

• Contact email

  C.Ritchie@brainsciences.scot

• Sponsor organisation

  Roche Diagnostics International Ltd

• ISRCTN Number

  ISRCTN63463784

• Duration of Study in the UK

  1 years, 6 months, 28 days

• Research summary

  The study is a Clinical Performance Study of the Elecsys® Amyloid Plasma Panel (EAPP). The EAPP is an In-vitro Diagnostic Medical Device (IVD) comprised of two separate IVD assays: Elecsys® Phospho-Tau (181P) plasma (pTau181p), and Elecsys® Apolipoprotein E4 plasma (ApoE4p). The EAPP aims to provide an aid for the timely detection of amyloid pathology, a key characteristic of Alzheimer’s Disease, using blood-based biomarkers. Current approved methods for detection of amyloid pathology are CSF analysis (requiring lumbar puncture) and PET scan. Please note, the study is for a standalone diagnostic and is not associated with any pharmaceutical trial.
  The present study will include two study parts to achieve the following aims:
  Study Part 1 (cutoff establishment): Determination of the EAPP score calculation algorithm, Total Error allowable and clinical decision point (cutoff) for EAPP score and the pTau181p assay individually, in the intended-use population.
  Study Part 2 (pivotal clinical study): Validation of the clinical performance of the EAPP score, and of the pTau181p assay individually, in the intended-use population.

  In addition to this, there is an additional aim of validating the clinical performance of the ApoE4p sub-result individually in the intended-use population.

  The results of the EAPP will be compared to both CSF and PET, to show the clinical performance of the EAPP. To this end, the following will be collected prospectively from subjects: clinical and cognitive data, blood samples, CSF samples and brain images (Amyloid PET and MRI). Up to 4 visits are required for the subject to collect this data, and these visits will be done within 3 months.

  The results of this study will be used to support submission for both FDA approval in US and Conformité Européenne (CE) marking in Europe. The data may also be used for submissions in further countries in the future.

  Lay summary of study results: The two investigational products: Elecsys Phospho-Tau 181 and Elecsys Apolipoprotein E4 met the acceptance criteria and showed acceptable ability to detect their respective biomarkers. The overall results of this study support the intended use of the products in a clinical setting for early detection of amyloid pathology in adult subjects who are being evaluated for AD and other causes of cognitive decline.
  Has the registry been updated to include summary results?: No
  If yes - please enter the URL to summary results:
  If no – why not?: This will be done by end of October 2025
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: Internal reports and submission to regulatory authorities are complete. Peer reviewed journal publications are in progress
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: No
  If yes, describe and/or provide URLs to materials shared and how they were shared:
  If pending, date when feedback is expected:
  If no, explain why they haven't: No necessary for this non-interventional study
  Have you enabled sharing of study data with others?: Yes
  If yes, describe or provide URLs to how it has been shared: Data available on request
  If no, explain why sharing hasn't been enabled:
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: No requests to share samples or data received
  Captcha: 0cAFcWeA5Pc1eIbDh_ZnvV39D-OvJnDojO2yeGJzg3fwrzk2qkuvrvldItTsLRX5Vx769FN-rqWneoJhxzyOi13Ho0HGFOUwU9JjnZNYXqv33qlRqW65nvil9sxWccpcKGccn1daQQZh7iJFLROCvvlgA3RIWoEsIUwtUBi-lv8JnY_86rFAyX2HAbGkEMjv3hioWBG59E6JhCEG-nOXFoT25iyCUX0XUnp1HST3uT-cn7gHdBKYXXo9x1Hoo9XfAc2XBtRjwcg4rhdaw-XMyUn7AhfnH87KjQSZ7fAFVxC4U4oDmZgImqnU48940--n1IJOg_lNG9o_VAcQr5U96mH_OUItlB_1RZv3F1DXNv2us6ajHij0Bb6oUhSje74Ek0k0VmnkOU5qQnugZFf7nBaBWIupUVCAtgLIWurmkpGGDTPoHcfU0HcyipnAod64ebKOAPJ8m1tPgriV0gv4luXjxH-GpKOohDYRwVevxLlEP0VAzqRZttaO0nzEN3LJBh1m5OAZSJCCuvRsYzshMYMzg3KAph_KXbAjQ8tNImZCy_apMB_oxfoYAuIEiOAf6QD1jXFzEJGSd05TL_23xhnmYIvuu3nHuKqqNjQFE9euSXVbLUiV_wQpV8uAF7LsKSjDCTwvq6sNcyY2Ok_hLZOgVq9jYVU68Z_hq6C9DNLJxsWZA1eOb-m_MN2GWsT4EW9aqI5_Yqg_tg0VYMtwmP1-MX0lE_Z0OpoNGmKuOg1RBaMugJ09nG2QqQy3yLvXISVSa7YLeSeWmmbTL7omaIMre1lYwCPYJUyykidlB82EhwvliLdZZWHX4

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  23/LO/0483

• Date of REC Opinion

  18 Jul 2023

• REC opinion

  Further Information Favourable Opinion