Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Mental Strategy Training in Mild Cognitive Impairment

14 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

55

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Autre: 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.
Expérimental: 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).
Autre: 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.
Expérimental: 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).
Autre: 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.
Comparateur actif: 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).
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Hippocampal activity during the pattern separation task
Délai: 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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pattern completion errors
Délai: 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
Délai: 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
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Jessica Peter

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 février 2024

Achèvement primaire (Réel)

22 octobre 2025

Achèvement de l'étude (Réel)

22 octobre 2025

Dates d'inscription aux études

Première soumission

14 juillet 2026

Première soumission répondant aux critères de contrôle qualité

14 juillet 2026

Première publication (Réel)

22 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 50089

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner