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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

30 mars 2011 mis à jour par: Exonhit

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).

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.

Aperçu de l'étude

Statut

Complété

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

550

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Ballainvilliers, France, 91160
        • Hôpital Privé Les Magnolias
      • Bergerac, France, 24100
        • Cabinet Médical
      • Dijon, France, 21000
        • Centre Médical
      • La Seyne sur Mer, France, 83500
        • Cabinet Médical
      • Le Vesinet, France, 78110
        • Cabinet Médical
      • Magnanville, France, 78200
        • Clinique Léopold Bellan
      • Marseille, France, 13001
        • Cabinet Médical
      • Montpellier, France, 34000
        • Centre Médical
      • Montpellier, France, 34080
        • Cabinet Médical
      • Montpellier, France, 34295
        • CMRR Gui de Chauliac Hospital
      • Nantes, France, 44093
        • CHU Nantes Hôpital Laennec
      • Nantes, France, 44300
        • ClinOuest network
      • Nice, France, 06000
        • Cabinet Médical
      • Nice, France, 06000
        • Cabinet Médical 2
      • Paris, France, 75016
        • Cabinet Médical
      • Rambouillet, France, 78120
        • Centre Médical
      • Rodez, France, 12000
        • Cabinet Médical
      • Rueil Malmaison, France, 92500
        • Cabinet Médical
      • Saint Brieuc, France, 22000
        • Cabinet Médical
      • Toulouse, France, 31059
        • Purpan-Casselardit Hospital - University of Toulouse
      • Valence, France, 26000
        • CDPRV Le Capitole

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Alzheimer's Disease
Group of patients clinically diagnosed with probable AD
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,...)
Autre: 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.
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,...)
Autre: control subjects
Group of control subjects without any clinical cognitive impairment.
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,...)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
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.
Délai: day 1 (cross-sectional study)
day 1 (cross-sectional study)

Mesures de résultats secondaires

Mesure des résultats
Délai
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.
Délai: day1 (cross-sectional study)
day1 (cross-sectional study)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Directeur d'études: Olivier SOL, MD, Exonhit
  • Chercheur principal: Bruno Vellas, MD, Purpan- Casselardit Hospital - Toulouse University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2008

Achèvement primaire (Réel)

1 février 2011

Achèvement de l'étude (Réel)

1 février 2011

Dates d'inscription aux études

Première soumission

10 avril 2009

Première soumission répondant aux critères de contrôle qualité

10 avril 2009

Première publication (Estimation)

13 avril 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

31 mars 2011

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 mars 2011

Dernière vérification

1 mars 2011

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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