Performance of AclarusDx™, a Blood-Based Transcriptomic Test for AD, in US Patients Newly Referred to a Memory Center
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|