Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Mild Cognitive Impairment in Older Adults With and Without Depressive Symptom

5. november 2026 opdateret af: University Medical Centre Maribor

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).

Studieoversigt

Status

Ikke rekrutterer endnu

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: CASE_CONTROL
  • Tidsperspektiver: CROSS_SECTIONAL

Kohorter og interventioner

Gruppe / kohorte
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.

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Visuospatial Task Performance
Tidsramme: At the baseline study visit.

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.
Emotional Capture Task Performance
Tidsramme: At the baseline study visit.

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.
Social Cognition Performance on the Faux Pas Test
Tidsramme: At the baseline study visit.

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.
Regional DNA Methylation (BDNF, COMT and SLC6A4 promoter gene regions)
Tidsramme: At the baseline study visit.

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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

23. november 2026

Primær færdiggørelse (Anslået)

31. august 2027

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

5. november 2026

Først indsendt, der opfyldte QC-kriterier

5. november 2026

Først opslået (Faktiske)

12. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

A decision has not yet been made about whether de-identified individual participant data from this study will be shared with other researchers.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner