Cognitive Impairment Clinical Trial
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
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.
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
;
Observational Model: Case-Only, Time Perspective: Cross-Sectional
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