Date: 2011-12-12
Type of information:
phase: observational study
Announcement: initiation
Company: Exonhit (France)
Product: AclarusDx®
Action mechanism: AclarusDx® is a blood-based test intended to help in the diagnosis of Alzheimer’s disease (AD). This test is based on the compared analysis of AD patients’ transcriptome with that of healthy controls. It was developed by identifying a signature gathering biomarkers linked to more than 130 genes including some genes particularly involved in inflammatory and immune mechanisms observed in AD. A French multicenter blind validation study involving 164 individuals, has allowed establishing the assay performance: a sensitivity of 81% and a specificity of 67%(1). CE marked since March 2011, AclarusDx® is being made available progressively to expert memory centers in France prior to wider distribution to specialized memory consultations in France and other European countries. AclarusDx® is for investigational use only in United States.
Disease: Alzheimer\'s disease
Therapeutic area: Neurodegenerative diseases
Country: France
Trial
details: The main objective of DIALOG (DIagnostic ALzheimer cOGnitif), a non interventional longitudinal study of the diagnosis of AD, is the evaluation of the positivity of AclarusDx® in AD patients among the population of patients consulting for the first time with French specialized memory centers (Centres Mémoire de Ressources et de Recherche, CMRR, or Consultations Mémoire, CM). This population of newly referred patients includes patients suffering from cognitive disorders and/or memory impairment for whom a specialized exploration using AclarusDx® blood-based test is needed. The study should enroll 600 patients that will be followed by 30 to 50 CMRR or CM for the usual diagnostic workup. A blood sample required for performing the AclarusDx® test will be collected during the first visit, together with other biological samples. Further follow-up data will be collected 6 months and 1 year after the initial visit. This study received the approval of both the CCTIRS on September 15, 2011 and the CNIL on October 14, 2011. On September 22, 2011, thestudy was also submitted to the CNOM who did not express opposition.
Latest
news: Exonhit has announced the launch of its observational study in France aimed at evaluating the performance of AclarusDx®, a bloodbased test intended to aid in the diagnosis of Alzheimer’s disease (AD), in patients consulting for the first time with a specialized memory center for AD diagnostic work-up. This real-life study named DIALOG (DIagnostic ALzheimer cOGnitif) is sponsored by Exonhit and has received all regulatory approvals. The first patient recruitment is expected in December.
