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

Observational MCI Dementia Mild Cognitive Impairment (MCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: MCI, Dementia, Mild Cognitive Impairment (MCI). Basic parameters: 55 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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: +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.

Primary outcome measures

  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Greece · 1 center
  • Outpatient clinic of the 3rd Department of Psychiatry, School of Medicine, General Univers — Thessaloniki

Publications

  • Hsieh S, Schubert S, Hoon C, Mioshi E, Hodges JR. Validation of the Addenbrooke's Cognitive Examination III in frontotemporal dementia and Alzheimer's disease. Dement Geriatr Cogn Disord. 2013;36(3-4):242-50. doi: 10.1159/000351671. Epub 2013 Aug 15. PMID 23949210
  • Breton A, Casey D, Arnaoutoglou NA. Cognitive tests for the detection of mild cognitive impairment (MCI), the prodromal stage of dementia: Meta-analysis of diagnostic accuracy studies. Int J Geriatr Psychiatry. 2019 Feb;34(2):233-242. doi: 10.1002/gps.5016. Epub 2018 Nov 27. PMID 30370616
  • Julayanont P, Brousseau M, Chertkow H, Phillips N, Nasreddine ZS. Montreal Cognitive Assessment Memory Index Score (MoCA-MIS) as a predictor of conversion from mild cognitive impairment to Alzheimer's disease. J Am Geriatr Soc. 2014 Apr;62(4):679-84. doi: 10.1111/jgs.12742. Epub 2014 Mar 17. PMID 24635004
  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. PMID 15817019

Identifiers

NCT: NCT07297121 · 207/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗