- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07931586
Mild Cognitive Impairment in Older Adults With and Without Depressive Symptom
Factors Differentiating Older Adults With Mild Cognitive Impairment and Depressive Symptoms From Those With Mild Cognitive Impairment Without Depressive Symptoms
This study will compare adults aged 65 years or older who have mild cognitive impairment, with and without depressive symptoms. The researchers plan to participants at University Medical Centre Maribor, with two equally sized groups. They will compare outcomes in several different cognitive domains (visuospatial abilities, emotional modulation, social cognition) and in DNA methylation of relevant regions (for BDNF, COMT, and SLC6A4 gene promoters).
Panoramica dello studio
Stato
Descrizione dettagliata
This cross-sectional observational study will examine cognitive and epigenetic differences between older adults with mild cognitive impairment who have depressive symptoms and those who do not. Potential participants will be identified through the outpatient psychogeriatric, psychiatric, and neurology clinics and the inpatient geriatric psychiatry units at University Medical Centre Maribor. Participants will be aged 65 years or older, have cognitive screening results consistent with mild cognitive impairment, and provide written informed consent. The planned sample will include two equally sized groups of participants.
Participants will be classified according to the presence or absence of depressive symptoms at the initial assessment. Depressive symptoms will be reassessed early in the study to confirm group classification. Participants will receive the same standard of diagnostic assessment and treatment as patients who do not take part in the study.
The study will compare performance on tasks assessing visuospatial abilities, emotional modulation abilities and social cognition. The investigators hypothesize that participants with depressive symptoms will perform better on the visuospatial task and less well on the emotional capture and social cognition tasks than participants without depressive symptoms. Blood samples will be collected to compare DNA methylation in the promoter regions of BDNF, COMT, and SLC6A4 between the two groups.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Eva Nike Cvikl
- Numero di telefono: +38640336780
- Email: eva.nike.cvikl@gmail.com
Luoghi di studio
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Maribor, Slovenia, 2000
- University Medical Centre Maribor
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Contatto:
- Eva Nike Cvikl
- Numero di telefono: +38640336780
- Email: eva.nike.cvikl@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
The study population will consist of adults aged 65 years or older with cognitive screening results consistent with mild cognitive impairment. Potential participants will be identified at University Medical Centre Maribor through the outpatient psychogeriatric, psychiatric, and neurology clinics and the inpatient geriatric psychiatry units. The planned sample includes equal numbers of participants with depressive symptoms without depressive symptoms.
Descrizione
Inclusion Criteria:
- Age 65 years or older.
- Receiving outpatient or inpatient psychiatric care with a working diagnosis of a mood, anxiety, or cognitive disorder.
- Cognitive screening results consistent with mild cognitive impairment.
- Written informed consent to participate in the study.
Exclusion Criteria:
- Established diagnosis of Alzheimer's disease or another specific form of dementia.
- Established diagnosis of another specific neurological or neurodegenerative disease.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: CASE_CONTROL
- Prospettive temporali: CROSS_SECTIONAL
Coorti e interventi
Gruppo / Coorte |
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Mild Cognitive Impairment With Depressive Symptoms
Adults aged 65 years or older with mild cognitive impairment and depressive symptoms, as determined by the study's depression assessment. |
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Mild Cognitive Impairment Without Depressive Symptoms
Adults aged 65 years or older with mild cognitive impairment without depressive symptoms, as determined by the study's depression assessment. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Visuospatial Task Performance
Lasso di tempo: At the baseline study visit.
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Visuospatial performance will be measured using computer guided cognitive task (n-back). Values will be compared between participants with mild cognitive impairment with and without depressive symptoms. |
At the baseline study visit.
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Emotional Capture Task Performance
Lasso di tempo: At the baseline study visit.
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Emotional capture will be assessed using the computer guided Emotional Capture Task. Values will be compared between participants with mild cognitive impairment with and without depressive symptoms. |
At the baseline study visit.
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Social Cognition Performance on the Faux Pas Test
Lasso di tempo: At the baseline study visit.
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Social cognition will be assessed using the Faux Pas Test. Scores will be compared between participants with mild cognitive impairment with and without depressive symptoms. |
At the baseline study visit.
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Regional DNA Methylation (BDNF, COMT and SLC6A4 promoter gene regions)
Lasso di tempo: At the baseline study visit.
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DNA methylation will be measured in target regions using DNA obtained from blood samples. Results will be compared between participants with mild cognitive impairment with and without depressive symptoms. |
At the baseline study visit.
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- depressione
- cognizione sociale
- lieve deterioramento cognitivo
- teoria della mente
- depressione negli anziani
- depressione geriatrica
- funzioni esecutive
- metilazione del DNA
- cognitive symptoms of depression
- cognitive decline in depression
- depressive pseudodementia
- psychomotor speed
- BDNF gene
- COMT gene
- SLA6A4 gene
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UKCMB-PSIH-MCI-2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
A decision has not yet been made about whether de-identified individual participant data from this study will be shared with other researchers.
Informazioni su farmaci e dispositivi, documenti di studio
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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 .