NCT07297121

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: [phone] 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.

Conditions

• MCI
• Dementia
• Mild Cognitive Impairment (MCI)

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2025-12-22
• Last updated: 2025-12-22

Locations

1 site across 1 country: Greece