ClinicalTrials.gg
Not yet recruitingNCT07931586Updated Nov 12, 2026

Mild Cognitive Impairment in Older Adults With and Without Depressive Symptom

An observational study in Mild Cognitive Impairment (MCI) and Depression and Anxiety Symptoms, sponsored by University Medical Centre Maribor. Not yet recruiting at 1 site in Slovenia. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University Medical Centre Maribor · Observational

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Cognitive Dysfunction with a site in Slovenia — 1 open to participants now, 2 under way, none of them phase 3. Cognitive Dysfunction · Slovenia.

Started
2026
with 1 other
Observational
5 of 12
1 open now
Registered
12th of 12
by date
Lead sponsor
1 of 12
University Medical Centre Maribor

Among the 12 studies in Cognitive Dysfunction with a site in Slovenia, this one is one of 2 that started in 2026, is one of 5 observational ones, and was the 12th registered.

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

Browse Cognitive Dysfunction studies →

Open to participants now

1 of the 12 studies in Cognitive Dysfunction with a site in Slovenia is open now.

A study can be open while its sites in Slovenia have not opened yet or have stopped. Only those recruiting at a site in Slovenia →

Who these studies take

Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.

This study: 65 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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).

Read the detailed description

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.

03

Conditions studied

  • Mild Cognitive Impairment (MCI)
  • Depression and Anxiety Symptoms

Keywords

  • mild cognitive impairment
  • depression
  • depression in the elderly
  • geriatric depression
  • cognitive symptoms of depression
  • cognitive decline in depression
  • depressive pseudodementia
  • executive functions
  • psychomotor speed
  • social cognition
  • theory of mind
  • dna methylation
  • BDNF gene
  • COMT gene
  • SLA6A4 gene
04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Established diagnosis of Alzheimer's disease or another specific form of dementia.
  • Established diagnosis of another specific neurological or neurodegenerative disease.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Visuospatial Task Performance

    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.

    Time frame: At the baseline study visit.

  2. Emotional Capture Task Performance

    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.

    Time frame: At the baseline study visit.

  3. Social Cognition Performance on the Faux Pas Test

    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.

    Time frame: At the baseline study visit.

  4. Regional DNA Methylation (BDNF, COMT and SLC6A4 promoter gene regions)

    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.

    Time frame: At the baseline study visit.

07

Study locations

1 site
08

References and documents

Individual participant data

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

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Aug 2027, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 12, 2026
StartEst.
Nov 23, 2026
Primary completionEst.
Aug 31, 2027
CompletionEst.
Jun 30, 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07931586
Lead sponsor
University Medical Centre Maribor
Collaborators
University Psychiatric Clinic Ljubljana, Medical Faculty Maribor
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Nov 23, 2026 (estimated)
Primary completion
Aug 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Nov 12, 2026

Study contacts

Eva Nike Cvikl
Contact
eva.nike.cvikl@gmail.com
+38640336780

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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