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

Mild Cognitive Impairment Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Aphasia
• Aphasia, Primary Progressive
• Cognition Disorders
• Dementia
• Dementia, Vascular
• Fronto-temporal Dementia
• Frontotemporal Dementia
• Mild Cognitive Impairment
• Mixed Dementia
• Parkinson Disease
• Parkinson' Disease Dementia
• Pick Disease of the Brain
• Primary Progressive Aphasia
• Vascular Dementia

• NCT number: NCT01465360
• Study type: Observational
• Source: Exonhit
• Status: Completed
• Phase: N/A
• Start date: November 2011