NCT07297121

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jan 2026Jun 2027

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 9, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

MCIMoCAMoCA-MISValidationMild Cognitive Impairmentscreeningdementiamemory testing

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (3)

Control Group

Group were patients have a MCI diagnosis

Demented patients

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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".

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Related Publications (4)

  • 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: 23949210BACKGROUND
  • 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: 30370616BACKGROUND
  • 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: 24635004BACKGROUND
  • 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: 15817019BACKGROUND

MeSH Terms

Conditions

DementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Central Study Contacts

Dr Nikitas A. Arnaoutoglou, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations