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

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.

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Key information

Conditions

Cognitive Impairment Clinical Investigation in Memory Centers Cognition Disorders Cognitive Dysfunction Memory Complaint Mental Disorders Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Diaxonhit

Industry

Collaborators

Olivier SOL, MD

Registry information

Official study 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

Acronym: DIALOG

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Aug 20, 2014
Registry last updated: Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed