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Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia
This study is currently recruiting participants.
Verified by Exonhit Therapeutics, April 2009
First Received: April 10, 2009   No Changes Posted
Sponsored by: Exonhit Therapeutics
Information provided by: Exonhit Therapeutics
ClinicalTrials.gov Identifier: NCT00880347
  Purpose

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.


Condition Intervention
Alzheimer's Disease
Dementia
Device: Blood sampling

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease Dementia
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Single Blind (Outcomes Assessor), Single Group Assignment
Official Title: 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).

Further study details as provided by Exonhit Therapeutics:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: day1 (cross-sectional study) ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: February 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Alzheimer's Disease
Group of patients clinically diagnosed with probable AD
Device: Blood sampling
Venous blood sampling in PaxGene tubes intended to collect blood RNA that will be then analyzed using SpliceArray (tm) technology for transcriptomic profile. sAPPalpha levels will be also dosed. Clinical data to be collected in parallel (medical history, concomitant treatment, MMSE,clinical examination,...)
Non-AD dementia
Group of patients clinically diagnosed with one of the 5 most frequent non-AD dementia : vascular dementia, mixed dementia, frontotemporal dementia, Lewy bodies dementia, Parkinson's disease dementia.
Device: Blood sampling
Venous blood sampling in PaxGene tubes intended to collect blood RNA that will be then analyzed using SpliceArray (tm) technology for transcriptomic profile. sAPPalpha levels will be also dosed. Clinical data to be collected in parallel (medical history, concomitant treatment, MMSE,clinical examination,...)
control subjects
Group of control subjects without any clinical cognitive impairment.
Device: Blood sampling
Venous blood sampling in PaxGene tubes intended to collect blood RNA that will be then analyzed using SpliceArray (tm) technology for transcriptomic profile. sAPPalpha levels will be also dosed. Clinical data to be collected in parallel (medical history, concomitant treatment, MMSE,clinical examination,...)

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. AD group :

    • 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.
  2. 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,
    • LBD according to McKeith's criteria, or,
    • FTD according to Neary's or Lund & Manchester criteria or,
    • PDD according to DSM-IV TR criteria [F02.x] or,
    • Mixed dementia which is defined in this study as patients fulfilling DSM-IV TR criteria [F02.8] for dementia with multiple aetiologies focussing on dementia of Alzheimer type with secondary occurrence of vascular dementia.
    • 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 diagnosis of dementia, and that the results are compatible with the diagnosis of dementia.
    • Absence of other signs or symptoms that may be better related to another type of dementia than the current dementia diagnosis.
    • Patient compliant with study procedures.
  3. Cognitive impairment-free control group :

    • Male or female subject, aged ≥ 60 years old included at entry.
    • Written informed consent obtained from the subject.
    • Absence of spontaneously reported significant cognitive complaints from the subject at entry.
    • MMSE ≥ 27 at entry.
    • Subject with no impairment in daily living activities.
    • Subject compliant with study procedures.

Exclusion Criteria:

  1. AD group :

    • 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.
  2. 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.
    • 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 the diagnostic criteria for dementia, 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.
    • Current or recent history of drug or alcohol abuse or dependence.
    • Pregnancy.
    • Patient who is not registered at "Sécurité Sociale".
    • Current participation in another study using an investigational non-marketed product.
  3. Cognitive impairment-free control group :

    • Subject spontaneously complaining from significant cognitive impairment.
    • Known family history of dementia.
    • Diagnosis of any type of dementia (either AD or non-AD dementia), Mild Cognitive Impairment, or any current or past history of CNS pathology (including but not limited to brain injury, brain tumour, stroke, normal pressure hydrocephalus, Parkinson's disease, epilepsy, multiple sclerosis,…) that may be responsible for the occurrence of dementia.
    • History or current clinically significant psychiatric pathology (including but not limited to psychotic disorders, bipolar disorder, personality disorders).
    • Current major depressive disorder, either treated or not, associated with clinically significant symptoms.
    • Any current pathology or medical condition for which blood sampling may involve a risk for the subject's health, according to the opinion of the investigator.
    • Current or recent history (within one month) of clinically significant pathology, medical condition (including hospitalization) or symptoms. However, chronic diseases or medical conditions which are considered stable are accepted, provided that they are compatible with other study selection criteria.
    • Current or recent history of drug or alcohol abuse or dependence.
    • Subject who is not registered at "Sécurité Sociale".
    • Current participation in another study using an investigational non-marketed product.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880347

Contacts
Contact: Olivier Sol +33153945245 olivier.sol@exonhit.com

Locations
France
Cabinet Médical Recruiting
Marseille, France, 13001
CHU Nantes Hôpital Laennec Recruiting
Nantes, France, 44093
Clinique Léopold Bellan Recruiting
Magnanville, France, 78200
Hôpital Privé Les Magnolias Recruiting
Ballainvilliers, France, 91160
Purpan-Casselardit Hospital - University of Toulouse Recruiting
Toulouse, France, 31059
ClinOuest network Completed
Nantes, France, 44300
Centre Médical Recruiting
Montpellier, France, 34000
CDPRV Le Capitole Recruiting
Valence, France, 26000
Centre Médical Recruiting
Dijon, France, 21000
Centre Médical Recruiting
Rambouillet, France, 78120
Cabinet Médical 2 Recruiting
Nice, France, 06000
Cabinet Médical Recruiting
Bergerac, France, 24100
Cabinet Médical Recruiting
Le Vesinet, France, 78110
Cabinet Médical Recruiting
Montpellier, France, 34080
Cabinet Médical Recruiting
Rodez, France, 12000
Cabinet Médical Recruiting
Saint Brieuc, France, 22000
Cabinet Médical Recruiting
Nice, France, 06000
CMRR Gui de Chauliac Hospital Recruiting
Montpellier, France, 34295
Cabinet Médical Recruiting
La Seyne sur Mer, France, 83500
Cabinet Médical Recruiting
Rueil Malmaison, France, 92500
Cabinet Médical Recruiting
Paris, France, 75016
Sponsors and Collaborators
Exonhit Therapeutics
Investigators
Study Director: Olivier SOL, MD Exonhit Therapeutics
Principal Investigator: Bruno Vellas, MD Purpan- Casselardit Hospital - Toulouse University
  More Information

No publications provided

Responsible Party: University of Toulouse - Purpan - Casselardit Hospital ( Professor Bruno Vellas, MD )
Study ID Numbers: EHTAD/002
Study First Received: April 10, 2009
Last Updated: April 10, 2009
ClinicalTrials.gov Identifier: NCT00880347     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Exonhit Therapeutics:
Alzheimer's disease
Other dementia
Vascular dementia
Mixed dementia
Parkinson's Disease dementia
Lewy bodies dementia
Frontotemporal dementia
Blood signature
Diagnosis
SpliceArray (tm)
Alzheimer's Disease and other non-AD dementia

Study placed in the following topic categories:
Pick Disease of the Brain
Lewy Body Dementia
Primary Progressive Aphasia
Alzheimer Disease
Central Nervous System Diseases
Lewy Body Disease
Brain Diseases
Neurodegenerative Diseases
Aphasia, Primary Progressive
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Frontotemporal Dementia
Mental Disorders
Parkinson Disease
Dementia, Vascular
Dementia
Lobar Atrophy of Brain
Delirium

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009