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

July 4, 2012 updated by: Exonhit

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Cleveland Clinic Lou Ruvo Center for Brain Health
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Center for Brain Health - Mellen Center
      • Lakewood, Ohio, United States, 44107
        • Cleveland Clinic Senior Care Assessment - Lakewood Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study patients
Patients newly referred to a Reference Memory Center with a complaint of memory impairment for AD diagnostic workup.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Outcome measured during one single study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exonhit

Investigators

  • Principal Investigator: Charles B. Bernick, MD, Cleveland Clinic Lou Ruvo Center for Brain Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Study Registration Dates

First Submitted

October 28, 2011

First Submitted That Met QC Criteria

November 2, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Estimate)

July 6, 2012

Last Update Submitted That Met QC Criteria

July 4, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHTAD/003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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