- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07718945
Mental Strategy Training in Mild Cognitive Impairment
2026. július 14. frissítette: 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.
A tanulmány áttekintése
Állapot
Befejezve
Beavatkozás / kezelés
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
55
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
-
-
Canton of Bern
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Bern, Canton of Bern, Svájc, 3000
- Universitäre Psychiatrische Dienste Bern
-
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Igen
Leírás
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)
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Aktív összehasonlító: 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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Hippocampal activity during the pattern separation task
Időkeret: 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).
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Pattern completion errors
Időkeret: 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
Időkeret: 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.
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We will asssess pattern separation success 4 times from baseline until the last assessment (approximately 10 weeks later).
|
|
Lure Discrimination Index
Időkeret: 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).
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: Jessica Peter, Professor, University Hospital of Old Age Psychiatry and Psychotherapy
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2024. február 13.
Elsődleges befejezés (Tényleges)
2025. október 22.
A tanulmány befejezése (Tényleges)
2025. október 22.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. július 14.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. július 14.
Első közzététel (Tényleges)
2026. július 22.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. július 22.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. július 14.
Utolsó ellenőrzés
2026. július 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 50089
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
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