Performance of AclarusDx® a Blood-Based Transcriptomic Test for AD, in French Patients Newly Referred to a Memory Center (DIALOG)

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: NCT02221661
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 22, 2014
Olivier SOL, MD
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 complaint and/or cognitive impairments.

Condition or disease
Cognitive Impairment Memory Complaint Clinical Investigation in Memory Centers

Detailed Description:

The objective of this study is to apply AclarusDx™ signature in 600 patients newly referred in french memory centers. 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 physicians with a tool that will help them in making the diagnosis of Alzheimer's Disease (AD).

The primary objective is to estimate the prevalence of positive AclarusDx™ in patients diagnosed AD in the population of primary consultants. This population of primary consultants consists of patients with cognitive impairment and / or a memory complaint requiring specialized exploration using AclarusDx™ blood test and which may be potentially related to multiple and different etiologies.

The secondary objectives are:

  • Assess the prevalence of positive AclarusDx™ in relation to other diagnoses (MCI, vascular dementia ...) established by the physician investigator at the end of specialized assessment.
  • Identify the demographic factors anamnestic, clinical, biological and imaging associated with positivity of AclarusDx™
  • Identify the demographic factors anamnestic, clinical, biological and imaging associated with the diagnosis of AD and other diagnoses.
  • Determine the contribution of AclarusDx™ in the usual battery of tests performed for diagnostic approach to Alzheimer's disease and to identify a possible association of interest with one or more endpoints (clinical, neuropsychological, brain, biological imaging).
  • Assess: diagnostic status at 6 and 12 months, and the MMSE and IADL at 6 and 12 months.
  • assess the predictive value of AclarusDx™ achieved during the initial visit to the diagnosis of AD is 12 months.
  • Evaluate AclarusDx™ predictive value to 12 months

Study Type : Observational [Patient Registry]
Actual Enrollment : 606 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 12 Months
Official Title: Non-interventional Longitudinal Study in Alzheimer Disease Diagnosis in Primary Consultants Patients With Cognitive and / or Memory Complaint Requiring Specialized Exploration Using AclarusDx® Blood Test in Memory Centers
Study Start Date : December 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Primary Outcome Measures :
  1. Estimation of the prevalence of positive AclarusDx™ among patients clinically AD diagnosed [ Time Frame: Outcome measured during one single study visit ]

    The primary outcome is to estimate the prevalence of positive AclarusDx Alzheimer patients diagnosed (excluding MCI).

    The prevalence is estimated as a percentage calculated among patients being confirmed clinically as having AD at the Memory Center and having a positive or negative AclarusDx™ result

Biospecimen Retention:   Samples With DNA
Whole blood samples collected in PAXgene® blood RNA tubes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with cognitive impairment and/or memory complaint justifying a first clinical investigation for diagnosis

Inclusion Criteria:

  • male and female adult patients
  • suffering from cognitive impairment and/or memory complaint and justifying a first clinical investigation at the memory center

Exclusion Criteria:

  • patient already followed up by the memory center
  • patient unable to comply with study procedures

Responsible Party: Diaxonhit Identifier: NCT02221661     History of Changes
Other Study ID Numbers: MG/JD/11.830
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014

Keywords provided by Diaxonhit:
cognitive impairment
blood test

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders