Memory Aid - Working Memory Training in Patients With Mild Cognitive Impairment. (MCI)
Memory Aid - Computer Based Working Memory Training in Elderly With Mild Cognitive Impairment (MCI). A Randomized, Controlled Trial.
Background:
Mild Cognitive Impairment (MCI) is a condition characterized by memory problems more severe than normal cognitive changes due to old age, and less severe than dementia. Reduced working memory (WM) is regarded as one of the core symptoms of an MCI-condition. Recent studies have indicated that WM can be improved trough computer based training.
Objectives:
The objective of the study is to evaluate if working memory training is effective in improving working memory in elderly MCI-patients. Further, to evaluate if cognitive training relates to structural changes in the white and gray matter of the brain, assessed by structural Magnetic Resonance Imaging. Cognitive phenotypes related to memory impairment and progression to dementia will also be investigated.
Patients and Methods:
The proposed study is a blinded, randomized and controlled trail that will include 90 elderly patients from a Memory Clinic diagnosed with MCI. The groups will be randomized to either training or a placebo version. The intervention is computerized working memory training performed for 45 minutes over 25 sessions. Neuropsychological assessment and structural MRI will be performed before, 6 and 12 months after training.
Relevance:
Currently there is no known treatment available for mild memory impairment/MCI, and few studies on specific cognitive training in MCI-patients have been performed. The proposed study has received funding from a Norwegian Health Region. If computer based training results in positive changes to memory functions in MCI patients this may represent a new, cost-effective treatment. Secondly, evaluation of training induced structural changes to grey or white matter may improve our understanding of the mechanisms behind effective cognitive interventions in MCI patients.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Aust-Agder
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Arendal, Aust-Agder, Noruega, 4838
- Recrutamento
- Sorlandet Hospital HF
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Contato:
- Susanne S Hernes, MD
- Número de telefone: 0047-48136020
- E-mail: susanne.sorensen.hernes@sshf.no
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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:
Patients who meet the Peterson diagnostic criteria of MCI:
- memory complaints (preferably confirmed by an informant).
- memory impairment according to age and education.
- preserved general cognitive function.
- intact activities of daily living, absence of dementia.
Exclusion Criteria:
- head trauma with post-traumatic loss of conscience for 30 minutes during lifespan.
- loss of senses (blindness, deafness).
- photo-sensitive epilepsy.
- unsuitability for Magnetic Resonance Imaging-examination due to metal foreign bodies or severe claustrophobia.
- drug and/or alcohol abuse.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Falso: Computerized Working Memory Training.
The Working Memory Training, includes both auditive and visual tasks, administrated on a computer, under guidance.
5 x 45 minutes per week, for 5 weeks.
The placebo group will train at an fixed level (non-adaptive), but with otherwise identical computer programs.
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Auditive and visual Working Memory tasks, administrated on a computer under guidance.
5 x 45 minutes per week, for 5 weeks.
The intervention group will train at an "adaptive" level that is not to difficult nor to easy, which is hypothesized as optimal for learning and training effect.
The placebo group will train with a "sham" program that is fixed ("non-adaptive" in difficulty level), but otherwise identical.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Working Memory function.
Prazo: Changes from baseline (3, 6 and 12 months after intervention).
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The study seeks to assess changes in the patients working memory function after an intervention of working memory training.The construct of "Working Memory" is measured on several levels: by neuropsychological tests (cognitive level), assessment of daily living skills (ADL-level), and measures of changes in the brains white and gray matter in areas that are correlated with working memory function (brain level).
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Changes from baseline (3, 6 and 12 months after intervention).
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Episodic memory function.
Prazo: Changes from baseline (3, 6 and 12 months after intervention).
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We will measure the patients results on a word list task, both immediate and delayed recall, as well as recognition.
Low scores on word list learning is associated with progression to dementia.
It is anticipated that patients with MCI are at risk for developing dementia.
The study seeks to investigate if there is a correlation between the results on memory tests and progression to dementia in this patient group.
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Changes from baseline (3, 6 and 12 months after intervention).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Svein Gunnar Gundersen, PhD, Head of research department
Publicações e links úteis
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 (Estimativa)
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
- MCI Working Memory Training.
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