Performance of AclarusDx™, a Blood-Based Transcriptomic Test for AD, in US Patients Newly Referred to a Memory Center
|ClinicalTrials.gov Identifier: NCT01465360|
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : July 6, 2012
|Condition or disease|
|Alzheimer's Disease Mild Cognitive Impairment Vascular Dementia Fronto-temporal Dementia Primary Progressive Aphasia Parkinson' Disease Dementia Mixed Dementia|
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.
|Study Type :||Observational|
|Actual Enrollment :||160 participants|
|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|
|Study Start Date :||November 2011|
Patients newly referred to a Reference Memory Center with a complaint of memory impairment for AD diagnostic workup.
- Sensitivity of AclarusDx™ in AD patients [ Time Frame: Outcome measured during one single study visit ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|