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

This study has been completed.
Information provided by (Responsible Party):
Exonhit Identifier:
First received: October 28, 2011
Last updated: July 4, 2012
Last verified: July 2012
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.

Alzheimer's Disease
Mild Cognitive Impairment
Vascular Dementia
Fronto-temporal Dementia
Primary Progressive Aphasia
Parkinson' Disease Dementia
Mixed Dementia

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Exonhit:

Primary Outcome Measures:
  • 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

Enrollment: 160
Study Start Date: November 2011
Study patients
Patients newly referred to a Reference Memory Center with a complaint of memory impairment for AD diagnostic workup.

Detailed 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.

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Caucasian patients that are newly referred to a Reference Memory Center with a complaint of memory impairment will be enrolled in the study.

Inclusion Criteria:

  • Male or female patient referred to the center for memory impairment.
  • The memory impairment has previously been observed by a caregiver or documented by a physician.
  • The memory impairment is confirmed by the memory center.
  • Caucasian ethnicity.
  • A written informed consent approved by an ethical review board or similar body must be obtained from the patient prior to any study-related procedures.
  • If applicable, standard treatment with cholinesterase inhibitor and/or memantine is acceptable.
  • Patient estimated to be compliant with study procedures.
  • Patient has a level of understanding sufficient to agree to all procedures required by the protocol and must be able to cooperate. Under no circumstances will a subject who does not understand the procedure, be allowed to consent to the procedure.

Exclusion Criteria:

  • Recent acute pathology or medical condition or surgery which may alter the inflammatory homeostasis, according to the opinion of the investigator.
  • Non-Caucasian ethnicity.
  • Patient with severe uncontrolled or unstable medical condition.
  • Need for a legal representative for the medical condition of the patient.
  • Any current pathology or medical condition, for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator.
  • Current or recent history (within one month) of clinically significant pathology, medical condition (including hospitalization) or symptoms. However, chronic diseases or medical conditions that are considered stable are accepted, provided that they are compatible with other study selection criteria.
  • Current or recent history of drug or alcohol abuse or dependence.
  • Current, clinically significant major psychiatric disorder (eg, major depressive disorder) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition text revised (DSM-IV TR), or significant symptoms (eg, hallucinations).
  • Woman of childbearing potential is not allowed to participate in the study. (A woman of childbearing potential is a woman who is biologically capable of becoming pregnant).
  • Current participation in another study using an investigational non-marketed product.
  Contacts and Locations
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Please refer to this study by its 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
Sponsors and Collaborators
Principal Investigator: Charles B. Bernick, MD Cleveland Clinic Lou Ruvo Center for Brain Health
  More Information

Additional Information:
Responsible Party: Exonhit Identifier: NCT01465360     History of Changes
Other Study ID Numbers: EHTAD/003 
Study First Received: October 28, 2011
Last Updated: July 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Exonhit:
Non AD dementia
Vascular dementia
Fronto-temporal dementia
Parkinson's Disease dementia
Mixed dementia
Alzheimer's Disease and other non-AD dementia
Alzheimer's disease
Mild Cognitive Impairment
Primary progressive aphasia
Blood signature

Additional relevant MeSH terms:
Dementia, Vascular
Frontotemporal Dementia
Alzheimer Disease
Aphasia, Primary Progressive
Cognition Disorders
Mild Cognitive Impairment
Parkinson Disease
Pick Disease of the Brain
Arterial Occlusive Diseases
Basal Ganglia Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Communication Disorders
Frontotemporal Lobar Degeneration
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Language Disorders
Mental Disorders
Metabolic Diseases
Movement Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurocognitive Disorders
Neurodegenerative Diseases processed this record on May 26, 2016