- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00880347
Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia
30 de março de 2011 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
550
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Ballainvilliers, França, 91160
- Hôpital Privé Les Magnolias
-
Bergerac, França, 24100
- Cabinet Medical
-
Dijon, França, 21000
- Centre Médical
-
La Seyne sur Mer, França, 83500
- Cabinet Medical
-
Le Vesinet, França, 78110
- Cabinet Medical
-
Magnanville, França, 78200
- Clinique Léopold Bellan
-
Marseille, França, 13001
- Cabinet Medical
-
Montpellier, França, 34000
- Centre Médical
-
Montpellier, França, 34080
- Cabinet Medical
-
Montpellier, França, 34295
- CMRR Gui de Chauliac Hospital
-
Nantes, França, 44093
- CHU Nantes Hôpital Laennec
-
Nantes, França, 44300
- ClinOuest network
-
Nice, França, 06000
- Cabinet Medical
-
Nice, França, 06000
- Cabinet Médical 2
-
Paris, França, 75016
- Cabinet Medical
-
Rambouillet, França, 78120
- Centre Médical
-
Rodez, França, 12000
- Cabinet Medical
-
Rueil Malmaison, França, 92500
- Cabinet Medical
-
Saint Brieuc, França, 22000
- Cabinet Medical
-
Toulouse, França, 31059
- Purpan-Casselardit Hospital - University of Toulouse
-
Valence, França, 26000
- CDPRV Le Capitole
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
40 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: 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,...)
|
|
Outro: 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,...)
|
|
Outro: 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,...)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
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.
Prazo: day 1 (cross-sectional study)
|
day 1 (cross-sectional study)
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
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.
Prazo: day1 (cross-sectional study)
|
day1 (cross-sectional study)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Olivier SOL, MD, Exonhit
- Investigador principal: Bruno Vellas, MD, Purpan- Casselardit Hospital - Toulouse University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de fevereiro de 2008
Conclusão Primária (Real)
1 de fevereiro de 2011
Conclusão do estudo (Real)
1 de fevereiro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
10 de abril de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de abril de 2009
Primeira postagem (Estimativa)
13 de abril de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
31 de março de 2011
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de março de 2011
Última verificação
1 de março de 2011
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EHTAD/002
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Blood sampling
-
Centre Hospitalier Universitaire de NiceRecrutamentoDoença de AlzheimerFrança
-
Beijing GoBroad HospitalRecrutamentoEsclerose Sistêmica | Nefrite Lúpica Refratária | Síndrome de Sjogren primária combinada com hipertensão pulmonarChina
-
Haydarpasa Numune Training and Research HospitalConcluídoDistúrbio hemorrágicoPeru
-
Rush University Medical CenterNational Institute of Neurological Disorders and Stroke (NINDS)RecrutamentoHemorragia intracerebral primáriaEstados Unidos
-
University Hospital, RouenRecrutamentoHepatite B | Hepatite C | AUXILIAFrança
-
MicroPhage, Inc.ConcluídoSepse | Bacteremia | Infecção | Infecção EstafilocócicaEstados Unidos
-
University Hospital TuebingenRecrutamentoPredisposição genética para doenças | Doenças rarasAlemanha
-
University of PennsylvaniaChildren's Hospital of Philadelphia; PharPoint Research, Inc.; Cooperative Human... e outros colaboradoresInscrevendo-se por convite
-
University Hospital, LimogesNational Agency for Research on AIDS and Viral Hepatitis (ANRS)RecrutamentoVírus da Hepatite B CrônicaFrança
-
Methodist Health SystemAinda não está recrutandoColangite Biliar Primária