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- Klinische proef 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).
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Eva Nike Cvikl
- Telefoonnummer: +38640336780
- E-mail: eva.nike.cvikl@gmail.com
Studie Locaties
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Maribor, Slovenië, 2000
- University Medical Centre Maribor
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Contact:
- Eva Nike Cvikl
- Telefoonnummer: +38640336780
- E-mail: eva.nike.cvikl@gmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: CASE_CONTROL
- Tijdsperspectieven: CROSS_SECTIONAL
Cohorten en interventies
Groep / Cohort |
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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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Visuospatial Task Performance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UKCMB-PSIH-MCI-2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
A decision has not yet been made about whether de-identified individual participant data from this study will be shared with other researchers.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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