Performance of AclarusDx™, a Blood-Based Transcriptomic Test for AD, in US Patients Newly Referred to a Memory Center



Status:Archived
Conditions:Alzheimer Disease, Cognitive Studies, Parkinsons Disease, Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology, Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:November 2011
Contact:Carol Varela, CCRC
Phone:702 331 7053

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Performance of AclarusDx™, A Blood-Based Transcriptomic Test for Alzheimer's Disease, in US-based Patients Suffering From Memory Impairment and Newly Referred to A Reference Memory Center, for AD Diagnostic Workup—A Pilot Descriptive Study


The purpose of this study is to assess the performance of AclarusDx™, an investigational
blood test detecting gene expression information, and intended to help physicians in making
an Alzheimer's Disease diagnosis in patients having memory impairments.


The objective of this study is to apply AclarusDx™ signature in a reference US Center in 160
patients newly referred to one of the three study centers within the Cleveland Clinic,
Center for Brain Health network, for diagnostic workup. Only AclarusDx™ will be added to the
panel of tests usually performed at the centers to establish diagnosis. AclarusDx™ will be
used for investigational use only, not for diagnostic purpose. The ultimate goal is to
define the clinical utility of AclarusDx™ to provide Primary Care Physicians (PCPs) with a
tool that will help them in making the diagnosis of Alzheimer's Disease (AD).

The primary objectives are :

1. To obtain an estimate of the capability of AclarusDx™ to identify AD patients among a
US-based population of newly referred patients suffering from objective memory
impairment which maybe potentially related to multiple and different etiologies.

2. To compare the performance of AclarusDx™ in a US-based population of newly referred
patients with memory impairment with the performance of AclarusDx™ observed in one
comparable European population.


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