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

Cognitive Impairment Clinical Trial

— DIALOG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221661
• Other study ID #: MG/JD/11.830
• Status: Completed
• Phase: N/A
• First received: August 19, 2014
• Last updated: August 21, 2014
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: Diaxonhit
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 606
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Clinical Investigation in Memory Centers
• Cognition Disorders
• Cognitive Impairment
• Memory Complaint

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Diaxonhit	Olivier SOL, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of the prevalence of positive AclarusDx™ among patients clinically AD diagnosed	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 measured during one single study visit	No