- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07718945
Mental Strategy Training in Mild Cognitive Impairment
14 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
55
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Canton of Bern
-
Bern, Canton of Bern, Svizzera, 3000
- Universitäre Psychiatrische Dienste Bern
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Hippocampal activity during the pattern separation task
Lasso di tempo: 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).
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pattern completion errors
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Jessica Peter, Professor, University Hospital of Old Age Psychiatry and Psychotherapy
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
13 febbraio 2024
Completamento primario (Effettivo)
22 ottobre 2025
Completamento dello studio (Effettivo)
22 ottobre 2025
Date di iscrizione allo studio
Primo inviato
14 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
14 luglio 2026
Primo Inserito (Effettivo)
22 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 50089
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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