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

Completed

• Conditions: Memory Complaint; Clinical Investigation in Memory Centers; Cognitive Impairment

• Registration Number: NCT02221661
• Lead Sponsor: Diaxonhit

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.

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 Timeline

• Study Start: 2011-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-08
• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-20
• Last Update Submitted: 2014-08-21
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 606

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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