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

Sponsor
Diaxonhit (Industry)
Overall Status
Completed
CT.gov ID
NCT02221661
Collaborator
Olivier SOL, MD (Other)
606
Enrollment
24
Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    606 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    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 :
    Dec 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Estimation of the prevalence of positive AclarusDx™ among patients clinically AD diagnosed [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Diaxonhit
    • Olivier SOL, MD

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Diaxonhit
    ClinicalTrials.gov Identifier:
    NCT02221661
    Other Study ID Numbers:
    • MG/JD/11.830
    First Posted:
    Aug 20, 2014
    Last Update Posted:
    Aug 22, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by Diaxonhit
    Alzheimer
    cognitive impairment
    blood test
    Additional relevant MeSH terms:
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Aug 22, 2014