- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01839422
Imaging of New Learning in Severe Alzheimer's Disease Patients (INCAS)
Functionnal Magnetic Resonnance Imaging (fMRI)Study of Cerebral Substrates of New Musical and Pictorial Learning in Alzheimer Patients
This research attempts to better understand the altered and preserved memory mechanisms in Alzheimer disease, particularly to better apprehend learning implicit memory processes, and give a scientific support to non-pharmalogical interventions. At the present time, it is possible to delay the emergence of the symptoms related to this disease, eventually to decrease it, but not to cure it. Yet, care these patients became a crucial question and the solutions proposed to healthy aging people are not appropriate for Alzheimer patients who present specific disorders. The improvement of the quality of life of the institutionalized patients lies on a better comprehension of their disorders but also of their preserved abilities. The literature testifies of a great heterogeneity in the clinical expression of this disease, however we noticed two constants with regard to the capabilities generally announced as being preserved, on one hand, the implicit memory, and on the other hand the artistic aptitudes, and more particularly musical capabilities.
Patients with Alzheimer disease present a particularly severe and early deterioration of episodic memory. Thus, at the beginning of the disease the explicit acquisition of new knowledge becomes increasingly difficult. However, some clinical observations, such as new learning of unknown songs, even with patients at a severe stage of the illness, seem to support the assumption of a preservation of some implicit learning abilities. Indeed, several studies already showed preserved implicit memory capabilities among patients with Alzheimer disease, mostly at the beginning stage of the illness: preserved effects of perceptual priming, procedural learning. Thus, we are mainly interested by the effects of exposure and the rising of a feeling of familiarity, both showing preserved implicit learning abilities, for moderate to severe Alzheimer patients. However, no study was carried out to date using the neuroimaging techniques, among Alzheimer patients at a moderated to severe stage of illness, with the main objective to identify the cerebral substrates implied in the learning of new knowledge.
Indeed, several studies already showed preserved implicit memory capabilities among patients with Alzheimer disease, mostly were performed at the beginning stage of the illness and none of them have studied theses learning abilities for moderate to severe Alzheimer patients.
The objective of this work is to specify, in severe form of Alzheimer disease, the cognitive mechanisms allowing the memorizing (feeling of familiarity) of new information and thus to highlight neural networks underlying this learning process (recently learned stimuli vs old stimuli). The goal is to propose a positive image of the Alzheimer patients, in understanding which cognitive mechanisms and cerebral areas allow these learning capabilities.
20 patients Alzheimer at a moderate to severe stage, 20 patients at a mild to moderate stage of the illness, and 20 healthy aging participants, are selected after a neurological interview and a neuropsychological evaluation. The whole of the included participants take part of the experimental protocol organized in two phases: - the phase of familiarization and the phase of test. The phase of familiarization consists of the repeated exposure (daily session before the MRI acquisition) of new songs and new painting until obtaining a high feeling of familiarity for each item. The phase of test is carried out in the 3T MRI camera, it comprises an anatomical (T1, T2 MRI) and a functional acquisitions. The functional acquisition corresponds to a passive listening and seeing tasks of musical and pictorial stimuli. Finally, all participants realize a debriefing phase that allows obtaining a feedback on the familiarity of stimuli presented during the functional acquisition.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Julien Chavant
- Número de telefone: +33231065495
- E-mail: memoire-rechcerche.caen@inserm.fr
Locais de estudo
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Caen, França, 14000
- Recrutamento
- GIP Cyceron
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Investigador principal:
- Vincent de La Sayette, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Native language: French
Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:
- Healthy Elderly volunteers: over 60 years old, living at home, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery.
- Alzheimer's patients: presenting the standard criteria of NINCDS-ADRDA probable Alzheimer's disease, including abnormal global cognitive function and deficits in at least two cognitive domains identified by the diagnostic battery.
Exclusion Criteria:
- The sudden onset of cognitive impairments (as opposed to their slow and gradual installation in Alzheimer's disease)
- A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint
- A history of major disease (an uncontrolled diabetes, a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer);
- A medication that may interfere with memory or metabolic measures
- A alcohol or drugs abuse
- The cons-indications to MRI (claustrophobia, metallic object in the body).
- A predominantly left-hand (score below 50% in Edinburgh Inventory)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Controls
Memory assessment.
Brain imaging examination MRI.
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Cognitive assessment : Neuropsycological tests, learning sessions of new stimuli.
Brain imaging examination : Structural and functional MRI to compare differences between each sample.
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Experimental: Beginner Alzheimer's Disease patients
Memory assessment.
Brain imaging examination MRI.
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Cognitive assessment : Neuropsycological tests, learning sessions of new stimuli.
Brain imaging examination : Structural and functional MRI to compare differences between each sample.
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Experimental: Severe Alzheimer's Disease patients
Memory assessment.
Brain imaging examination MRI.
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Cognitive assessment : Neuropsycological tests, learning sessions of new stimuli.
Brain imaging examination : Structural and functional MRI to compare differences between each sample.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Succesful learning of new songs and paintings, succesful MRI acquisitions.
Prazo: 10 days max. One week for the learning sessions, before MRI scans done one or two days after.
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10 days max. One week for the learning sessions, before MRI scans done one or two days after.
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Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (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 (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2011-A00351-40
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 .
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