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NCT Number: NCT07297121

Validation of the Montreal Cognitive Assessment (MoCA) Version 8.x and MoCA-MIS in Greece.

Objective: The purpose of this study is to assess the psychometric qualities of the Montreal Cognitive Assessment (MoCA) version 8.x in Greek, including the MoCA-MIS. We intend to examine the tool's reliability (internal consistency, test-retest reliability) and validity (construct validity, concurrent validity, and known-group validity).

Aim: The findings will support the tool's application for early cognitive impairment identification in clinical and research settings.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Outpatient clinic of the 3rd Department of Psychiatry, School of Medicine, General University Hospital of Thessaloniki "AHEPA", Aristotle University of Thessaloniki, Greece.

Thessaloniki, 54636, Greece

Location contact

Dr. Nikitas A. Arnaoutoglou, MD, PhD

CONTACT

[email protected]

302313303110

About this study

MoCA is an increasingly common instrument used for cognitive assessment globally. Version 8.x has been translated into Greek, however a validation is of great importance. The participants of this study will be recruited from the outpatient clinic of the 3rd Department of Psychiatry School of Medicine, General University Hospital of Thessaloniki "AHEPA".

The Greek version of MoCA 8.x will be used to evaluate the participants with an analogous cognitive test, such as Addenbrooke's Cognitive Examination (ACE-III) and the M-ACE.

Within 4 weeks, the MoCA will be administered again to a subgroup again in order to evaluate the tool's test-retest reliability. In addition to internal consistency, construct validity (as measured by factor analysis), concurrent validity (correlation with existing tools), and known-group validity (comparing scores between cognitively healthy individuals and those with MCI or dementia), known-group validity will also be evaluated.

Study Type and Time Frames:

Observational Model: Cohort Cross-sectional with a short-timed phase (test-retest). The study is estimated to be completed withing a year's period.

Measure Time Frame Description Internal Consistency Baseline Assessment of internal reliability Test-retest Reliability 4 weeks post-baseline Stability of the test over time Construct Validity Baseline Factor analysis to explore the underlying structure Concurrent Validity Baseline Correlation with established cognitive tools Known-groups Validity Baseline Score comparison across diagnostic groups

Eligibility Criteria:

  • Participants between the ages of 55-85
  • Fluent in Greek to avoid misunderstandings during the assessment
  • Participants must be able to provide informed consent

Exclusion criteria

  • History of severe psychiatric or neurological disorders apart from MCI/dementia
  • Patients having acute medical illnesses
  • Patients having severe hearing and/or visual impairments

Study's Population Size:

  • 50-100 Cognitively Healthy Adults
  • 50-75 MCI Patients
  • 50-75 Demented Patients

Location:

Outpatient clinic of the 3rd Department of Psychiatry, School of Medicine, General University Hospital of Thessaloniki "AHEPA", Aristotle University of Thessaloniki, Greece.

Kiriakidi 1, Thessaloniki 546 36 Contact: +302313303110

Principal Investigator:

Dr. Nikitas Arnaoutoglou, MD, PhD Affiliation: Assistant Professor of Psychiatry, 3rd Department of Psychiatry, School of Medicine, General University Hospital of Thessaloniki "AHEPA", Aristotle University of Thessaloniki.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants between the ages of 55-85
  • Fluent in Greek to avoid misunderstandings during the assessment
  • Participants must be able to provide informed consent

Exclusion criteria

  • History of severe psychiatric or neurological disorders apart from MCI/dementia
  • Patients having acute medical illnesses
  • Patients having severe hearing and/or visual impairments

Treatment and study plan

Primary outcomes

  1. The Validation of the Montreal Cognitive Assessment (MoCA) Version 8.x and MoCA-MIS in Greece.

    Time frame: From enrollment to the end of the follow-up period at 4 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Nikitas A. Arnaoutoglou, MD, PhD

CONTACT

[email protected]

+302313303110

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • MoCA Clinic and Institute

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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