- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00880347
Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia
30. března 2011 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Očekávaný)
550
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Ballainvilliers, Francie, 91160
- Hôpital Privé Les Magnolias
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Bergerac, Francie, 24100
- Cabinet Medical
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Dijon, Francie, 21000
- Centre Médical
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La Seyne sur Mer, Francie, 83500
- Cabinet Medical
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Le Vesinet, Francie, 78110
- Cabinet Medical
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Magnanville, Francie, 78200
- Clinique Léopold Bellan
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Marseille, Francie, 13001
- Cabinet Medical
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Montpellier, Francie, 34000
- Centre Médical
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Montpellier, Francie, 34080
- Cabinet Medical
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Montpellier, Francie, 34295
- CMRR Gui de Chauliac Hospital
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Nantes, Francie, 44093
- CHU Nantes Hôpital Laennec
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Nantes, Francie, 44300
- ClinOuest network
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Nice, Francie, 06000
- Cabinet Medical
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Nice, Francie, 06000
- Cabinet Médical 2
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Paris, Francie, 75016
- Cabinet Medical
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Rambouillet, Francie, 78120
- Centre Médical
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Rodez, Francie, 12000
- Cabinet Medical
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Rueil Malmaison, Francie, 92500
- Cabinet Medical
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Saint Brieuc, Francie, 22000
- Cabinet Medical
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Toulouse, Francie, 31059
- Purpan-Casselardit Hospital - University of Toulouse
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Valence, Francie, 26000
- CDPRV Le Capitole
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
40 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
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.
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.
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:
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.
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.
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: 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,...)
|
|
Jiný: 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,...)
|
|
Jiný: 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,...)
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
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.
Časové okno: day 1 (cross-sectional study)
|
day 1 (cross-sectional study)
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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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.
Časové okno: day1 (cross-sectional study)
|
day1 (cross-sectional study)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Olivier SOL, MD, Exonhit
- Vrchní vyšetřovatel: Bruno Vellas, MD, Purpan- Casselardit Hospital - Toulouse University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. února 2008
Primární dokončení (Aktuální)
1. února 2011
Dokončení studie (Aktuální)
1. února 2011
Termíny zápisu do studia
První předloženo
10. dubna 2009
První předloženo, které splnilo kritéria kontroly kvality
10. dubna 2009
První zveřejněno (Odhad)
13. dubna 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
31. března 2011
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
30. března 2011
Naposledy ověřeno
1. března 2011
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- EHTAD/002
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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