Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia : A Prospective Study for a Blood Diagnostic Test in Alzheimer's Disease - (Protocol n° EHTAD/002).

Exonhit10 sites in 1 country550 target enrollmentFebruary 2008

ConditionsAlzheimer's Disease Dementia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: Exonhit
Enrollment: 550
Locations: 10
Primary Endpoint: To define the test performance of the blood expression signatures in the intended use population of demented patients to differentiate AD patients from non-AD demented patients.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the study is to define the performance of blood-based signatures for Alzheimer's Disease (AD) in different patients populations including AD, non-AD dementia, and non-demented controls.

Detailed Description

The main objective of the study is to define the performance of blood-based transcriptomic signatures for AD, identified using SpliceArray tm technology, in the intended use population of patients suffering from dementia, including AD and the most common non-AD dementia (Lewy Bodies dementia, vascular dementia, fronto-temporal dementia, dementia due to Parkinson's Disease, and mixed dementia). A group of non-demented subjects will serve as a control reference.

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

February 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Exonhit

Eligibility Criteria

Inclusion Criteria

•Male or female patient, aged ≥ 40 years old included at entry.
•Patients having a clinical diagnosis of probable AD according to DSM-IV TR \[F00.xx\] and National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
•Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations.
•Evidence that brain imaging (either cerebral CT-scan or cerebral MRI) was performed to settle the AD diagnosis, and that the results are compatible with AD diagnosis.
•Neurological exam without any particularities or without any specific focal signs likely to be related to other conditions than AD.
•Patient compliant with study procedures.
•Non AD demented group :
•Male or female patient, aged ≥ 40 years old included at entry.
•Patients having a clinical diagnosis of dementia which can be one of the following :
•VaD according to NINDS-AIREN criteria or,

Exclusion Criteria

•Any pathology, medical condition or symptoms that may lead to reconsider the initial diagnosis of probable AD, or that may rend the initial diagnosis of probable AD doubtful at entry, according to the opinion of the investigator.
•Current or recent history of drug or alcohol abuse or dependence.
•Diagnostic of Mild Cognitive Impairment defined by subjective complaints from the patient regarding memory and/or cognitive symptoms, objective memory and/or cognitive impairment at testing but not meeting AD diagnostic criteria, and not affecting daily living activities.
•Current diagnosis of brain tumour.
•Any current pathology or medical condition, for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator.
•Pregnancy.
•Patient who is not registered at "Sécurité Sociale".
•Current participation in another study using an investigational non-marketed product.
•Non-AD demented group :
•Any pathology, medical condition or symptoms that may lead to reconsider the initial diagnosis of dementia the patient is suffering from, or that may rend the initial diagnosis of dementia doubtful at entry, according to the opinion of the investigator.

Outcomes

Primary Outcomes

To define the test performance of the blood expression signatures in the intended use population of demented patients to differentiate AD patients from non-AD demented patients.

Time Frame: day 1 (cross-sectional study)

Secondary Outcomes

Performance of blood signatures (AD versus control, AD vs each individual type of non-AD dementia,...). Specificity of the blood signatures versus NINCDS-ADRDA criteria. Exploratory assessment of clinical parameters that may influence blood signature.(day1 (cross-sectional study))