- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07718945
Mental Strategy Training in Mild Cognitive Impairment
14. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
55
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Canton of Bern
-
Bern, Canton of Bern, Sveits, 3000
- Universitäre Psychiatrische Dienste Bern
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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).
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Jessica Peter, Professor, University Hospital of Old Age Psychiatry and Psychotherapy
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. februar 2024
Primær fullføring (Faktiske)
22. oktober 2025
Studiet fullført (Faktiske)
22. oktober 2025
Datoer for studieregistrering
Først innsendt
14. juli 2026
Først innsendt som oppfylte QC-kriteriene
14. juli 2026
Først lagt ut (Faktiske)
22. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 50089
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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