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ADDIA Report Summary

Project ID: 674474

Periodic Reporting for period 1 - ADDIA (Validation of a fast and simple peripheral blood diagnostic biomarker kit for Alzheimer’s disease)

Reporting period: 2015-08-01 to 2016-07-31

Summary of the context and overall objectives of the project

Alzheimer’s disease in a mere blood drop! Validation of a fast and simple peripheral blood diagnostic.
Alzheimer’s Disease (AD) is the most common form of dementia (60 to 70% of dementia cases). Approximately 46.8 million people worldwide currently live with AD or other type of dementia. With an ageing population, this number is estimated to increase to 131.5 million by 2050 (World Alzheimer Report, 2015: Currently, no blood test to diagnose AD exists. A potential AD diagnosis is usually given by a combination of clinical examination, neuropsychological tests and neuroimaging, over several months or years. In addition, a lumbar puncture can be performed to detect biomarkers in cerebrospinal fluid, but this procedure is invasive. Consequently, AD clinical diagnosis is a real challenge for physicians! Rapid and reliable biochemical tests, based on peripheral biomarker detection, represent one of the most promising tracks to diagnose the pathology, to facilitate patient stratification and the assessment of efficacy of new therapeutic drug candidates under development in clinical trials in AD patients. Amoneta Diagnostics SAS has developed a diagnostic kit candidate based on blood biomarkers, which allows the diagnosis of AD using only one single blood sample, in a fast, non-invasive and inexpensive way. In this project, we will validate our diagnostic test by performing a Proof-of-Performance (PoP) clinical study in AD patients. The project is supported by the Alzheimer Europe association. Its successful implementation will have a strong impact on the quality of life of patients and a significant impact on the healthcare system and economy. At the end of this project, a validated and approved IVD biomarker assay will be available and ready for clinical applications.

< See attached picture - 1 : ADDIA test as the first blood cell based IVD test approved for the Alzheimer’s diagnosis. >

The ADDIA test is based on blood biomarkers detected by flow cytometry. Amoneta Diagnostics has acquired a pipeline of patents from the CNRS and has recently filled two new patents on the biomarkers and tests related to the ADDIA projects. The proof-of-concept and the analytical validation have already been obtained for the prototype biomarker assay. At the end of this 3-years project, a validated and CE registered IVD biomarker assay will be available that is ready for clinical applications, initial market introduction and further commercialization and implementation.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The ADDIA project was formally launched on August 01, 2015. The official kickoff meeting with the clinical partners took place on October 02, 2015 at Amoneta Diagnostics facility. Since the start of this project, we have made significant progress in achieving our targets. Four work packages out of five are currently active.

Clinical protocols for both the chronobiological and the Proof-of-Performance (PoP) Studies have been written. The clinical study protocols, informed consents and information brochure for patients and controls have been submitted to local country ethics committees and in addition in France to the ANSM (Agence Nationale de Sécurité du Medicament et des produits de santé) for authorization. Other supporting documents and Standard Operative Procedures (SOPs) for clinical operations are ready for both the chronobiological study and the PoP study. The First patient first visit (FPFV) of the PoP will be in September as foreseen in the initial planning in two countries and followed by others before the need of 2016. In order to receive regulatory advice on the analytical validation plan and clinical protocols, we also sought advice from European Medicine Agency (EMA). In parallel we already contacted the French Notified Body LNE/G-MED to obtain a technical and regulatory assistance, in order to properly prepare the file for the CE-mark. As a part of the commercialization plan, ADDIA project website is active since the beginning of this project and can be accessed on This website is a tool for dissemination of most up-to-date information about the project advancements.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The present ADDIA project aims to qualify the 1st innovative non-invasive blood based in vitro diagnostic test for Alzheimer disease. It is based on the use of unique proprietary tests to detect biomarkers relevant of AD pathology. These tests will meet an urgent medical need and will impact the Alzheimer field in various ways. First, it can help physicians to diagnose AD in a fast manner, and large Pharma to succeed in drug development (in recruiting well characterized cohorts and monitoring efficacy of drug candidates in clinical trial in AD patients) which contributes in making available future new disease-modifying therapies to patients. This delays the dependency state of the patients, relieving AD patients, their families, the health care systems. Since care for dependent AD patients is very expensive, ADDIA tests will significantly reduce direct and indirect healthcare costs. In summary, this project will have a strong impact on the quality of life of patients and a significant impact on the healthcare system and economy.

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