Validation of the Montreal Cognitive Assessment (MoCA) Version 8.x and MoCA-MIS in Greece.
NCT ID: NCT07297121
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
250 participants
OBSERVATIONAL
2026-01-01
2027-06-01
Brief Summary
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Aim: The findings will support the tool's application for early cognitive impairment identification in clinical and research settings.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Control Group
No interventions assigned to this group
Group were patients have a MCI diagnosis
No interventions assigned to this group
Demented patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Fluent in Greek to avoid misunderstandings during the assessment
* Participants must be able to provide informed consent
Exclusion Criteria
* Patients having acute medical illnesses
* Patients having severe hearing and/or visual impairments
55 Years
85 Years
ALL
Yes
Sponsors
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MoCA Clinic and Institute
OTHER
Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Locations
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Outpatient clinic of the 3rd Department of Psychiatry, School of Medicine, General University Hospital of Thessaloniki "AHEPA", Aristotle University of Thessaloniki, Greece.
Thessaloniki, , Greece
Countries
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Central Contacts
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Facility Contacts
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Dr. Nikitas A. Arnaoutoglou, MD, PhD
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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207/2025
Identifier Type: -
Identifier Source: org_study_id