- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07718945
Mental Strategy Training in Mild Cognitive Impairment
14. juli 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
55
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Canton of Bern
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Bern, Canton of Bern, Schweiz, 3000
- Universitäre Psychiatrische Dienste Bern
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hippocampal activity during the pattern separation task
Tidsramme: 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).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pattern completion errors
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jessica Peter, Professor, University Hospital of Old Age Psychiatry and Psychotherapy
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
13. februar 2024
Primær færdiggørelse (Faktiske)
22. oktober 2025
Studieafslutning (Faktiske)
22. oktober 2025
Datoer for studieregistrering
Først indsendt
14. juli 2026
Først indsendt, der opfyldte QC-kriterier
14. juli 2026
Først opslået (Faktiske)
22. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 50089
Plan for individuelle deltagerdata (IPD)
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