Date: 2011-10-26
Type of information:
phase: pilot
Announcement: authorisation
Company: Exonhit (France)
Product: AclarusDx™
Action mechanism: This blood-based test is based on the compared analysis of AD patients’ transcriptome with that of healthy controls. The test 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.
Disease: Alzheimer disease
Therapeutic area: Neurodegenerative diseases
Country: USA
Trial
details: This study will be conducted by the Cleveland Clinic Lou Ruvo Center for Brain Health. Patients for this pilot study will be recruited at three Cleveland Clinic sites: the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Nevada; Cleveland Clinic main campus in Cleveland, Ohio, and Lakewood Hospital in Lakewood, Ohio. A total of 160 new patients being seen for memory impairment will be enrolled in the study starting in November. At the end of the study, the blood samples will be sent to Exonhit, Paris facility, for AclarusDx™ test analysis. A French multicenter blind validation study involving 164 individuals, has allowed establishing the assay performance: a sensitivity of 81% and a specificity of 67%(2). 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.
Latest news: Exonhit has announced the Institutional Review Board (IRB) approval of Exonhit sponsored pilot clinical trial aimed at evaluating the performance of AclarusDx™, a blood based investigational diagnostic test, in US-based patients suffering from memory impairment and newly referred to a reference Memory Center for Alzheimer’s Disease (AD) diagnostic workup.
