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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 has been completed.
Sponsor:
Information provided by:
Exonhit
ClinicalTrials.gov Identifier:
NCT00880347
First received: April 10, 2009
Last updated: March 30, 2011
Last verified: March 2011
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
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).

Resource links provided by NLM:


Further study details as provided by Exonhit:

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: 550
Study Start Date: February 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880347

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

No publications provided

Responsible Party: Professor Bruno Vellas, MD, University of Toulouse - Purpan - Casselardit Hospital
ClinicalTrials.gov Identifier: NCT00880347     History of Changes
Other Study ID Numbers: EHTAD/002
Study First Received: April 10, 2009
Last Updated: March 30, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on November 25, 2014