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

August 21, 2014 updated by: Diaxonhit

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

606

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with cognitive impairment and/or memory complaint justifying a first clinical investigation for diagnosis

Description

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

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

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Diaxonhit

Collaborators

Olivier SOL, MD

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

December 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 19, 2014

First Posted (Estimate)

August 20, 2014

Study Record Updates

Last Update Posted (Estimate)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 21, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MG/JD/11.830

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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