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

December 9, 2025 updated by: Aristotle University Of Thessaloniki

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.

Study Overview

Status

Not yet recruiting

Conditions

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: +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.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr Nikitas A. Arnaoutoglou, MD, PhD
  • Phone Number: +302313303110
  • Email: narnaou@auth.gr

Study Locations

  • Greece
      • Thessaloniki, Greece, 54636
        • Outpatient clinic of the 3rd Department of Psychiatry, School of Medicine, General University Hospital of Thessaloniki "AHEPA", Aristotle University of Thessaloniki, Greece.
        • Contact:
          • Dr. Nikitas A. Arnaoutoglou, MD, PhD
          • Phone Number: 302313303110
          • Email: narnaou@auth.gr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

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".

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control Group
Group were patients have a MCI diagnosis
Demented patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
From enrollment to the end of the follow-up period at 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Collaborators

MoCA Clinic and Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 207/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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