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
Sponsor organisation
Roche Diagnostics International Ltd
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.
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