A multi-center proof-of-performance clinical study to validate blood-based biomarker candidates for the diagnosis of Alzheimer's disease

AB Destekli Diğer Projeler, 2017 - 2020

Proje Türü: AB Destekli Diğer Projeler
Başlama Tarihi: Şubat 2017
Bitiş Tarihi: Ocak 2020

Proje Özeti

ADDIA program (H2020) aims at the clinical Proof-of-Performance (PoP) of blood biomarkers for diagnosis of Alzheimer’s disease (AD). ADDIA program includes a small chronobiological study and the present multi-centre clinical PoP study on 800 subjects (400 AD and 400 non-AD).

Context of use:

To quantify the performance of ADDIA’ blood biomarkers for AD diagnosis (yes/no).

Since the main objective of the present multi-centre clinical study is to establish the performance of ADDIA’ blood cell-based biomarkers β-amyloid (Aβ) and protein kinase C (PKC) and corresponding assays and to seek approval as In-Vitro Diagnosis (IVD) test(s) specific for diagnosis of AD, and to validate the newly identified metabolomics and RNA signatures and selected protein biomarker candidates, we will use samples from:

o the patients recruited in the AD group and patients recruited in the non-AD neurodegenerative disorders (NAD) group who are accurately diagnosed during the pre-screening period, including by using three types of diagnostic methods: clinical neuropsychological scores, neuroimaging (at least volumetric structural MRI) and retrospective cerebrospinal (CSF) data: Aβ, total-Tau and p-tau biomarkers. Alternatively to absence of retrospective CSF data, retrospective Aβ PET /Tau PET scans can be used if compatible to diagnosis of respective diseases.

o the subjects recruited in the control group have no objective memory loss, normal results on neuropsychology tests, and normal neuroimaging findings for their age, including normal Aβ PET scan and Tau PET scan if retrospectively available, as well as normal CSF Aβ, total-Tau and p-Tau concentration if retrospectively available.

We will use for further validation of ADDIA’ biomarkers an integrative tool combining ADDIA’ blood biomarkers with cognitive scores and/or, neuroimaging (and/or retrospective CSF biomarker data). We will also test the impact of polymorphisms associated with AD, such as APOE e4 (known to be as risk factor of AD) on ADDIA’ blood biomarkers.