Performance of AclarusDx™, a Blood-Based Transcriptomic Test for AD, in US Patients Newly Referred to a Memory Center
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.
Mild Cognitive Impairment
Primary Progressive Aphasia
Parkinson' Disease Dementia
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||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|
- Sensitivity of AclarusDx™ in AD patients [ Time Frame: Outcome measured during one single study visit ] [ Designated as safety issue: No ]The determination of the sensitivity of the test, being the percentage of positive AclarusDx™ calls among referred patients being confirmed clinically as having AD at the Memory Center will be calculated.
Biospecimen Retention: Samples With DNA
Whole blood samples collected in PAXgene® blood RNA tubes
|Study Start Date:||November 2011|
Patients newly referred to a Reference Memory Center with a complaint of memory impairment for AD diagnostic workup.
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 :
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465360
|United States, Nevada|
|Cleveland Clinic Lou Ruvo Center for Brain Health|
|Las Vegas, Nevada, United States, 89106|
|United States, Ohio|
|Cleveland Clinic Center for Brain Health - Mellen Center|
|Cleveland, Ohio, United States, 44195|
|Cleveland Clinic Senior Care Assessment - Lakewood Hospital|
|Lakewood, Ohio, United States, 44107|
|Principal Investigator:||Charles B. Bernick, MD||Cleveland Clinic Lou Ruvo Center for Brain Health|