Mental Strategy Training in Mild Cognitive Impairment
14 de julio de 2026 actualizado 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
55
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Canton of Bern
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Bern, Canton of Bern, Suiza, 3000
- Universitäre Psychiatrische Dienste Bern
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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).
|
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).
|
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).
|
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 activo: 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).
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hippocampal activity during the pattern separation task
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pattern completion errors
Periodo de tiempo: 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).
|
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Pattern Separation success
Periodo de tiempo: 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).
|
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Lure Discrimination Index
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jessica Peter, Professor, University Hospital of Old Age Psychiatry and Psychotherapy
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
13 de febrero de 2024
Finalización primaria (Actual)
22 de octubre de 2025
Finalización del estudio (Actual)
22 de octubre de 2025
Fechas de registro del estudio
Enviado por primera vez
14 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de julio de 2026
Publicado por primera vez (Actual)
22 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 50089
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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