Clinical trial NCT02221661: Performance of AclarusDx® a Blood-Based Transcriptomic Test for AD, in French Patients Newly Referred to a Memory Center
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Memory Complaint
Clinical Investigation in Memory Centers
Keywords: Alzheimer
cognitive impairment
blood test
Lead sponsor: Diaxonhit
Sponsor class: INDUSTRY
Collaborators: name: Olivier SOL, MD
First posted: 2014-08-20
Enrollment: 606
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cognitive impairment and/or memory complaint justifying a first clinical investigation for diagnosis

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

Eligibility criteria: 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

Primary outcomes:
measure: Estimation of the prevalence of positive AclarusDx™ among patients clinically AD diagnosed
timeFrame: Outcome measured during one single study visit
Secondary outcomes:
Other outcomes:
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