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.|
|ClinicalTrials.gov Identifier: NCT02221661|
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 22, 2014
|Condition or disease|
|Cognitive Impairment Memory Complaint Clinical Investigation in Memory Centers|
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|
|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|
- 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