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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01465360
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : July 6, 2012
Information provided by (Responsible Party):

Brief 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.

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

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.

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Study Type : Observational
Actual Enrollment : 160 participants
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
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.

Primary Outcome Measures :
  1. 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
Whole blood samples collected in PAXgene® blood RNA tubes

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01465360

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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
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Principal Investigator: Charles B. Bernick, MD Cleveland Clinic Lou Ruvo Center for Brain Health
Additional Information:
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Responsible Party: Exonhit Identifier: NCT01465360    
Other Study ID Numbers: EHTAD/003
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012
Keywords provided by Exonhit:
Alzheimer's disease
Non AD dementia
Mild Cognitive Impairment
Vascular dementia
Fronto-temporal dementia
Primary progressive aphasia
Parkinson's Disease dementia
Mixed dementia
Blood signature
Alzheimer's Disease and other non-AD dementia
Additional relevant MeSH terms:
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Parkinson Disease
Alzheimer Disease
Dementia, Vascular
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases