Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Mental Strategy Training in Mild Cognitive Impairment

14 de julho de 2026 atualizado por: Jessica Peter

Reducing Hippocampal Hyperactivity in Patients With Mild Cognitive Impairment

This study aims to reduce hippocampal activity in people at high risk of developing Alzheimer's disease (AD) and aims to examine whether this improves their episodic memory performance. We apply mental strategy trainings with strategies extracted from our previous study that applied real-time fMRI neurofeedback to reduce hippocampal activity. Participants take part in mental strategy trainings 2, 4, or 6 times. At baseline and after each 2 trainings, we assess their hippocampal activity as well as their episodic memory performance using an fMRI pattern separation task. In addition, we will gather blood samples to obtain Apolipoprotein E gene status (ApoE, only once) as well as plasma pTau (pTau217; 4 time-points). ApoE will be included as a covariate in our statistical models. For pTau217, we will calculate the change between each assessment to examine whether the mental strategy training will change the accumulation of pTau217.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

55

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

  • Suíça
    • Canton of Bern
      • Bern, Canton of Bern, Suíça, 3000
        • Universitäre Psychiatrische Dienste Bern

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

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • diagnosis of Mild Cognitive Impairment
  • between 60 - 80 years of age
  • fluent in German
  • normal or corrected-to-normal vision
  • normal or corrected-to-normal hearing

Exclusion Criteria:

  • any history of seizures
  • current psychotropic medication
  • other severe neurological or psychiatric disease
  • current or lifetime drug or alcohol abuse
  • severe brain damage other than atrophy in the hippocampus or the medial temporal lobe
  • claustrophobia
  • magnetisable implants (e.g., cardiac pacemakers, brain stimulator)

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: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Group A: 15 participants will be assigned to group A
Group A will attend 6 mental strategy trainings and will start the training after the first assessment. The training content is identical for all groups. The groups differ only in the number of training sessions and in the timing of the intervention onset (i.e., after the first assessment or after three assessment time points).
Outro: Mental Strategy Training
Trainings will be done in groups of up to five people. During training, participants will be presented with an implicit pattern separation task (i.e., for which no response is necessary). At the same time, they will apply mental strategies that were beneficial for hippocampal activity reduction in our previous study. We will use four different mental strategies ("Imagination", "Bodily Perception", "Active Thinking" and "Visual Perception") during each of the training sessions. During imagination participants will need to vividly imagine a scene that exerts a calming effect on them. During "bodily perception" participants will be instruced to focus on their feet or hands while slowly contracting and relaxing them. During active thinking they will perform cognitive tasks such as reciting the alphabet or counting. During visual perception they will focus on a specific part of the presented image. The order of the mental strategies is similar for all participants and all trainings.
Experimental: Group B: 15 participants will be assigned to group B
Group B will attend 4 mental strategy trainings and will start with the training after the first assessment. The training content is identical for all groups. The groups differ only in the number of training sessions and in the timing of the intervention onset (i.e., after the first assessment or after three assessment time points).
Outro: Mental Strategy Training
Trainings will be done in groups of up to five people. During training, participants will be presented with an implicit pattern separation task (i.e., for which no response is necessary). At the same time, they will apply mental strategies that were beneficial for hippocampal activity reduction in our previous study. We will use four different mental strategies ("Imagination", "Bodily Perception", "Active Thinking" and "Visual Perception") during each of the training sessions. During imagination participants will need to vividly imagine a scene that exerts a calming effect on them. During "bodily perception" participants will be instruced to focus on their feet or hands while slowly contracting and relaxing them. During active thinking they will perform cognitive tasks such as reciting the alphabet or counting. During visual perception they will focus on a specific part of the presented image. The order of the mental strategies is similar for all participants and all trainings.
Experimental: Group C: 15 participants will be assigned to group C
Group C will attend 2 mental strategy trainings and will start with the training after the first assessment. The training content is identical for all groups. The groups differ only in the number of training sessions and in the timing of the intervention onset (i.e., after the first assessment or after three assessment time points).
Outro: Mental Strategy Training
Trainings will be done in groups of up to five people. During training, participants will be presented with an implicit pattern separation task (i.e., for which no response is necessary). At the same time, they will apply mental strategies that were beneficial for hippocampal activity reduction in our previous study. We will use four different mental strategies ("Imagination", "Bodily Perception", "Active Thinking" and "Visual Perception") during each of the training sessions. During imagination participants will need to vividly imagine a scene that exerts a calming effect on them. During "bodily perception" participants will be instruced to focus on their feet or hands while slowly contracting and relaxing them. During active thinking they will perform cognitive tasks such as reciting the alphabet or counting. During visual perception they will focus on a specific part of the presented image. The order of the mental strategies is similar for all participants and all trainings.
Comparador Ativo: Group D: 10 participants will be assigned to group D
Group D will attend 2 mental strategy trainings and will start with the training after the third assessment. The training content is identical for all groups. The groups differ only in the number of training sessions and in the timing of the intervention onset (i.e., after the first assessment or after three assessment time points).
Outro: Mental Strategy Training
Trainings will be done in groups of up to five people. During training, participants will be presented with an implicit pattern separation task (i.e., for which no response is necessary). At the same time, they will apply mental strategies that were beneficial for hippocampal activity reduction in our previous study. We will use four different mental strategies ("Imagination", "Bodily Perception", "Active Thinking" and "Visual Perception") during each of the training sessions. During imagination participants will need to vividly imagine a scene that exerts a calming effect on them. During "bodily perception" participants will be instruced to focus on their feet or hands while slowly contracting and relaxing them. During active thinking they will perform cognitive tasks such as reciting the alphabet or counting. During visual perception they will focus on a specific part of the presented image. The order of the mental strategies is similar for all participants and all trainings.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Hippocampal activity during the pattern separation task
Prazo: We assess hippocampal activity 4 times from baseline until the last assessment (approximately 10 weeks later).
In each 4 fMRI sessions, we apply a pattern separation task (i.e., the mnemonic similarity test, MST). Participants need to answer to specific trial types. These are stimuli of everyday objects and the participants have to identify if a stimulus is "new" (they have not seen it before), "old" (exactly the same stimulus has been presented already) or "similar" (a stimulus has been shown before but was different in shape or colour). During each task, we will evaluate their hippocampal activity using similar "lure" trials that rely on pattern separation.
We assess hippocampal activity 4 times from baseline until the last assessment (approximately 10 weeks later).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Pattern completion errors
Prazo: We will assess pattern completion errors 4 times from baseline until the last assessment (approximately 10 weeks later).
In each 4 fMRI sessions, we apply a pattern separation task (i.e., the mnemonic similarity test, MST). Participants need to answer to specific trial types. These are stimuli of everyday objects and the participants have to identify if a stimulus is "new" (they have not seen it before), "old" (exactly the same stimulus has been presented already) or "similar" (a stimulus has been shown before but was different in shape or colour). Pattern completion errors refer to the mis-identification of similar objects as being old.
We will assess pattern completion errors 4 times from baseline until the last assessment (approximately 10 weeks later).
Pattern Separation success
Prazo: We will asssess pattern separation success 4 times from baseline until the last assessment (approximately 10 weeks later).
Correct pattern separation occurs when a participant correctly identifies a similar objects as "similar" in the pattern separation task. Compared to the LDI, here we only focus only on correct responses without considering potential response biases.
We will asssess pattern separation success 4 times from baseline until the last assessment (approximately 10 weeks later).
Lure Discrimination Index
Prazo: We will evaluate the LDI 4 times from baseline until the last assessment (approximately 10 weeks later).
In each 4 fMRI sessions, participants will perform a pattern separation task (i.e., mnemonic similarity test, MST). A widely used metric to report performance in this task is the lure discrimination index (LDI) which is used to determine pattern separation abilities while accounting for response biases
We will evaluate the LDI 4 times from baseline until the last assessment (approximately 10 weeks later).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Jessica Peter

Investigadores

  • Investigador principal: Jessica Peter, Professor, University Hospital of Old Age Psychiatry and Psychotherapy

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 (Real)

13 de fevereiro de 2024

Conclusão Primária (Real)

22 de outubro de 2025

Conclusão do estudo (Real)

22 de outubro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

14 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de julho de 2026

Primeira postagem (Real)

22 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 50089

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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 .

Se inscrever