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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02221661

Acronym

DIALOG

Enrollment

606

Registered

2014-08-20

Start date

2011-12-31

Completion date

2013-12-31

Last updated

2014-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Investigation in Memory Centers, Cognitive Impairment, Memory Complaint

Keywords

Alzheimer, cognitive impairment, blood test

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results