- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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).
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Eva Nike Cvikl
- Telefonnummer: +38640336780
- E-Mail: eva.nike.cvikl@gmail.com
Studienorte
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Maribor, Slowenien, 2000
- University Medical Centre Maribor
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Kontakt:
- Eva Nike Cvikl
- Telefonnummer: +38640336780
- E-Mail: eva.nike.cvikl@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: CASE_CONTROL
- Zeitperspektiven: CROSS_SECTIONAL
Kohorten und Interventionen
Gruppe / Kohorte |
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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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Visuospatial Task Performance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- Depression
- soziale Wahrnehmung
- leichte kognitive Einschränkung
- Theorie des Geistes
- Depressionen bei älteren Menschen
- Altersdepression
- exekutive Funktionen
- DNA-Methylierung
- cognitive symptoms of depression
- cognitive decline in depression
- depressive pseudodementia
- psychomotor speed
- BDNF gene
- COMT gene
- SLA6A4 gene
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UKCMB-PSIH-MCI-2026
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
A decision has not yet been made about whether de-identified individual participant data from this study will be shared with other researchers.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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