Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease (GERIOX)
According to several reports, the oxidative stress and the nutrition could have an impact in the Alzheimer disease.
The association of these two parameters measurements and the cognitive impairment decline could help in a predictive diagnosis of cognitive decline evolution in patients presenting cognitive disorders.
This is a monocentric prospective "routine care" clinical trial on patients showing cognitive troubles especially memory complaints.
The objective is to demonstrate a correlation between oxydative stress and nutrition biomarkers and the clinical evolution of patients complaining of cognitive impairments.
The neuropsychologic data collection (the mini mental Status Examination (MMSE), the clock test, the Grober-Buschke test (FCSR-IR), the executive function evaluated by the Trail making test, and the medical imaging (by magnetic resonance imaging (MRI) or tomography in case of MRI contraindication) will be realized during the study inclusion phase in the usual intake of patients. Whole blood samples for the oxydative and nutrition biomarkers measurements will be taken at the study inclusion day during the stay at the Day hospital dedicated to the routine intake of patients issued from the memory consultation.
In this study, the principal evaluation criteria will be the MMSE score evolution during the 60 months of the patients follow-up, measured during the routine visits scheduled approximately every 6 months, according to the french national authority for health recommendations. It will allow evaluating the correlation between the cognitive decline evolution measured by MMSE during the Alzheimer disease or related diseases method during the 2 years follow-up, and the oxydative stress blood markers.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Marc BONNEFOY, Pr
- Número de telefone: +33 (0)4 78 86 15 81
- E-mail: marc.bonnefoy@chu-lyon.fr
Locais de estudo
-
-
-
Pierre Benite, França, 69495
- Recrutamento
- Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.
-
Contato:
- Marc BONNEFOY, Pr
- Número de telefone: +33 (0)4 78 86 15 81
- E-mail: marc.bonnefoy@chu-lyon.fr
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- >55 years old patient
- Patient seen during a memory consultation in geriatric Unit, Lyon Sud University Hospital
- Patient or legal representative and/or person of confidence who didn't express his opposition to the clinical assay participation.
- Patient registered to the general social insurance
- Complementary health check scheduled at day hospital, conventional hospitalization or regular consultation.
Exclusion Criteria:
- Patient unable to express his participation refusal and under curatorship or unforced by the court of justice
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Nutritional evaluation
|
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change (evolution) of patient's cognitive profile evaluation measured by MMSE score method during memory consultation follow-up, every 6 months until patient loss.
Prazo: at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
|
Patient cognitive profile evolution measured by successive MMSE score evaluations during follow-up memory consultation, every 6 months until patient loss.
|
at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
cognitive profile evaluation at inclusion phase
Prazo: at baseline (day 0)
|
Dubois's "5 words" test; free recall test; cued recall memory test; Trail Making Test Part A/Trail Making Test Part B (TMTA/TMTB)
|
at baseline (day 0)
|
|
Présence of cardiovascular risk factor
Prazo: at baseline (day 0)
|
arterial hypertension; Tobacco: estimated consumption in cigarettes pack per year; lipidemia: cholesterol, high-density lipoprotein cholesterol (HDLc), Triglycerides, low-density lipoprotein cholesterol (LDLc); diabetes: diabetes fasting blood glucose, HbA1c; prior cardiovascular histories: acute coronary syndrome, arteriopathy
|
at baseline (day 0)
|
|
treatment evaluation
Prazo: at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
|
drugs list, posology, indication Drug type (ACE inhibitors; NSAIDs; statins…) angiotensin-converting-enzyme inhibitor (ACE inhibitor) Nonsteroidal anti-inflammatory drugs (usually abbreviated to NSAIDs)
|
at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
|
|
Functionality
Prazo: at baseline (day 0) and at day hospital visit if need be (up to 48 months)
|
Katz and Lawton scores ( ADL/ IADL)
|
at baseline (day 0) and at day hospital visit if need be (up to 48 months)
|
|
Presence of anomalies on cerebral imaging data that evoke neuro-degenerative pathology, by MRI
Prazo: At day hospital visit if need be (up to 48 months)
|
Description: cortical atrophy; specific hippocampus cortex atrophy ( according to Sheltens classification); subcortical atrophy; vascular Leukoencephalopathy symptoms on T2-FLAIR sequence; micro-bleeds in T2 sequence; Iron deposition observed by MRI method (or CT scans if MRI is contraindicated)
|
At day hospital visit if need be (up to 48 months)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marc BONNEFOY, Pr, Hospices Civils de Lyon
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2014.860
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 .