NCT07630688

Brief Summary

This study aimed to evaluate the validity, reliability, and diagnostic accuracy of the Turkish version of MoCA-B in distinguishing healthy controls, mild cognitive impairment (MCI), and dementia patients within a low-education population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

June 2, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

MoCA-BdementiaturkishvalidityreliabilityMCIMMSECDR

Outcome Measures

Primary Outcomes (1)

  • MoCA-B cut off points

    Calculating cutoff values for dementia and MCI in untrained individuals using the MoCA-B test.

    at baseline and after 4 weeks (test-retest)

Secondary Outcomes (2)

  • Correlations of MoCA-B total score with MMSE and CDR

    data were collected between January 2024 and November 2025.

  • Subdomain-level analyses

    Data were collected between January 2024 and November 2025

Other Outcomes (1)

  • Educational/demographic factors in the use of MoCA-B testing.

    Data were collected between January 2024 and November 2025

Study Arms (3)

Dementia

Patients who had dementia

MCI

Patients who had mild cognitive impairment

Control

Healthy controls

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 50-100 years presenting with memory complaints were recruited from the Neurology and Dementia outpatient clinics of Antalya Training and Research Hospital (January 2024-November 2025). Eligibility required low educational attainment (illiterate to primary school level). The study enrolled 166 participants, including healthy controls (n=55), mild cognitive impairment (MCI) cases (n=55), and dementia cases (n=56), all clinically characterized within routine specialty-care evaluation.

You may qualify if:

  • Age 50-100 years
  • Presented with memory complaints and were evaluated in the Neurology/Dementia outpatient clinics of Antalya Training and Research Hospital (Jan 2024-Nov 2025)
  • Low educational attainment (illiterate to primary school level)
  • Provided informed consent

You may not qualify if:

  • Active psychiatric disorders / active psychopathology
  • Intracranial mass lesions
  • Secondary causes of dementia
  • Severe medical conditions affecting cognition
  • History of traumatic brain injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital, Neurology Department, University of Health Sciences (SBÜ), Türkiye

Antalya, Muratpaşa, 07030, Turkey (Türkiye)

Location

Related Publications (23)

  • Siddiqui M, Nyahoda T, Traber C, Elliott S, Wang V, Toledo-Franco L, Rodin MB. Screening for Cognitive Impairment in Primary Care: Rationale and Tools. Mo Med. 2023 Nov-Dec;120(6):431-439.

  • Franzen S; European Consortium on Cross-Cultural Neuropsychology (ECCroN); Watermeyer TJ, Pomati S, Papma JM, Nielsen TR, Narme P, Mukadam N, Lozano-Ruiz A, Ibanez-Casas I, Goudsmit M, Fasfous A, Daugherty JC, Canevelli M, Calia C, van den Berg E, Bekkhus-Wetterberg P. Cross-cultural neuropsychological assessment in Europe: Position statement of the European Consortium on Cross-Cultural Neuropsychology (ECCroN). Clin Neuropsychol. 2022 Apr;36(3):546-557. doi: 10.1080/13854046.2021.1981456. Epub 2021 Oct 6.

  • Klil-Drori S, Phillips N, Fernandez A, Solomon S, Klil-Drori AJ, Chertkow H. Evaluation of a Telephone Version for the Montreal Cognitive Assessment: Establishing a Cutoff for Normative Data From a Cross-Sectional Study. J Geriatr Psychiatry Neurol. 2022 May;35(3):374-381. doi: 10.1177/08919887211002640. Epub 2021 Apr 16.

  • Carton C, Calafiore M, Cauet C, Messaadi N, Bayen M, Wyts D, Messaadi W, Richebe T, Bayen S. Montreal Cognitive Assessment (MoCA) use in general practice for the early detection of cognitive impairment: a feasibility study. BJGP Open. 2025 Apr 24;9(1):BJGPO.2024.0039. doi: 10.3399/BJGPO.2024.0039. Print 2025 Apr.

  • Mulchandani R, Grover U, Ray S, Gandotra S, Dhamija RK, Lyngdoh T. Validating the Telephone Montreal Cognitive Assessment Scale-Hindi as a Remote Screening Tool for Mild Cognitive Impairment. Cogn Behav Neurol. 2025 Jun 1;38(2):35-42. doi: 10.1097/WNN.0000000000000389.

  • Avcil, C., H. Bulut, and G. Hızlı Sayar, Psikiyatrik Hastalıklar ve Damgalama. Üsküdar Üniversitesi Sosyal Bilimler Dergisi,

    RESULT
  • Scheenen ME, van den Brink RHS, Konstantinidou S, Lugtenburg A, Spit J, Hendriks GJ, Naarding P, de Vent NR, Kessels RPC, Oude Voshaar RC, Jeuring HW. Montreal Cognitive Assessment (MoCA) Norms for Older Patients with a Depressive Disorder. Med Sci (Basel). 2025 Dec 10;13(4):312. doi: 10.3390/medsci13040312.

  • Pinto JO, Dores AR, Peixoto B, Barbosa F. Ecological validity in neurocognitive assessment: Systematized review, content analysis, and proposal of an instrument. Appl Neuropsychol Adult. 2025 Mar-Apr;32(2):577-594. doi: 10.1080/23279095.2023.2170800. Epub 2023 Feb 8.

  • Atri A, Dickerson BC, Clevenger C, Karlawish J, Knopman D, Lin PJ, Norman M, Onyike C, Sano M, Scanland S, Carrillo M. The Alzheimer's Association clinical practice guideline for the diagnostic evaluation, testing, counseling, and disclosure of suspected Alzheimer's disease and related disorders (DETeCD-ADRD): Validated clinical assessment instruments. Alzheimers Dement. 2025 Jan;21(1):e14335. doi: 10.1002/alz.14335. Epub 2024 Dec 23.

  • Dickerson BC, Atri A, Clevenger C, Karlawish J, Knopman D, Lin PJ, Norman M, Onyike C, Sano M, Scanland S, Carrillo M. The Alzheimer's Association clinical practice guideline for the Diagnostic Evaluation, Testing, Counseling, and Disclosure of Suspected Alzheimer's Disease and Related Disorders (DETeCD-ADRD): Executive summary of recommendations for specialty care. Alzheimers Dement. 2025 Jan;21(1):e14337. doi: 10.1002/alz.14337. Epub 2024 Dec 23.

  • Gugler K, Funk C, Brodelius P. Elicitor-induced tyrosine decarboxylase in berberine-synthesizing suspension cultures of Thalictrum rugosum. Eur J Biochem. 1988 Jan 4;170(3):661-6. doi: 10.1111/j.1432-1033.1988.tb13748.x.

  • Malek-Ahmadi M, Nikkhahmanesh N. Meta-analysis of Montreal cognitive assessment diagnostic accuracy in amnestic mild cognitive impairment. Front Psychol. 2024 Feb 13;15:1369766. doi: 10.3389/fpsyg.2024.1369766. eCollection 2024.

  • Luo H, Andersson B, Wong GHY, Lum TYS. Longitudinal measurement properties of the Montreal Cognitive Assessment. J Clin Exp Neuropsychol. 2022 Nov;44(9):627-639. doi: 10.1080/13803395.2022.2148634. Epub 2022 Nov 30.

  • Luo H, Andersson B, Tang JYM, Wong GHY. Applying Item Response Theory Analysis to the Montreal Cognitive Assessment in a Low-Education Older Population. Assessment. 2020 Oct;27(7):1416-1428. doi: 10.1177/1073191118821733. Epub 2019 Jan 4.

  • White RS, Barber JM, Harp JP, Jicha GA. Examining the Effects of Formal Education Level on the Montreal Cognitive Assessment. J Am Board Fam Med. 2022 Dec 23;35(6):1043-1057. doi: 10.3122/jabfm.2022.220093R1.

  • Livingston G, Huntley J, Liu KY, Costafreda SG, Selbaek G, Alladi S, Ames D, Banerjee S, Burns A, Brayne C, Fox NC, Ferri CP, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Nakasujja N, Rockwood K, Samus Q, Shirai K, Singh-Manoux A, Schneider LS, Walsh S, Yao Y, Sommerlad A, Mukadam N. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet. 2024 Aug 10;404(10452):572-628. doi: 10.1016/S0140-6736(24)01296-0. Epub 2024 Jul 31. No abstract available.

  • Saleh AA, Alkholy RSAEHA, Khalaf OO, Sabry NA, Amer H, El-Jaafary S, Khalil MAEF. Validation of Montreal Cognitive Assessment-Basic in a sample of elderly Egyptians with neurocognitive disorders. Aging Ment Health. 2019 May;23(5):551-557. doi: 10.1080/13607863.2018.1428936. Epub 2018 Feb 9.

  • Huang L, Chen KL, Lin BY, Tang L, Zhao QH, Lv YR, Guo QH. Chinese version of Montreal Cognitive Assessment Basic for discrimination among different severities of Alzheimer's disease. Neuropsychiatr Dis Treat. 2018 Aug 21;14:2133-2140. doi: 10.2147/NDT.S174293. eCollection 2018.

  • Amatneeks TM, Hamdan AC. Montreal Cognitive Assessment for cognitive assessment in chronic kidney disease: a systematic review. J Bras Nefrol. 2019 Jan-Mar;41(1):112-123. doi: 10.1590/2175-8239-JBN-2018-0086. Epub 2019 Jan 24.

  • Zegarra-Valdivia JA, Chino B, Tituana K, Zapata-Restrepo L, Unaucho MM, Lopez-Norori M, Paredes-Manrique C, Custodio N. Dementia and Mild Cognitive Impairment Identification in Illiterate and Low-Educated People: Systematic Review About the Use of Brief Cognitive Screening Tools. Behav Sci (Basel). 2025 Feb 13;15(2):207. doi: 10.3390/bs15020207.

  • Mukadam N, Wolters FJ, Walsh S, Wallace L, Brayne C, Matthews FE, Sacuiu S, Skoog I, Seshadri S, Beiser A, Ghosh S, Livingston G. Changes in prevalence and incidence of dementia and risk factors for dementia: an analysis from cohort studies. Lancet Public Health. 2024 Jul;9(7):e443-e460. doi: 10.1016/S2468-2667(24)00120-8.

  • Lwere K, Muwonge H, Sendagire H, Gumikiriza-Onoria JL, Nakimbugwe R, Buwembo D, Nakasujja N, Kaddumukasa M. Cognitive screening and education: assessing the Montreal Cognitive Assessment's validity in older Ugandan populations. Acad Ment Health Well Being. 2025;2(3):10.20935/mhealthwellb7804. doi: 10.20935/mhealthwellb7804. Epub 2025 Jul 18.

  • Babacan-Yildiz G, Ur-Ozcelik E, Kolukisa M, Isik AT, Gursoy E, Kocaman G, Celebi A. [Validity and Reliability Studies of Modified Mini Mental State Examination (MMSE-E) For Turkish Illiterate Patients With Diagnosis of Alzheimer Disease]. Turk Psikiyatri Derg. 2016 Spring;27(1):41-6. Turkish.

Related Links

MeSH Terms

Conditions

BehaviorDementiaDiseaseAlzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsTauopathiesNeurodegenerative DiseasesCognition Disorders

Study Officials

  • Aylin YAMAN, Prof. MD.

    Antalya Training and Research Hospital, Neurology Department, University of Health Sciences (SBÜ), Türkiye

    STUDY CHAIR
  • Ali Rıza GÜNDÜZ, MD

    Antalya Training and Research Hospital, Neurology Department, University of Health Sciences (SBÜ), Türkiye

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 5, 2026

Study Start

January 1, 2024

Primary Completion

November 1, 2025

Study Completion

March 30, 2026

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the primary and secondary analyses will be shared, including: participant age, sex, education level, diagnostic group (healthy control/MCI/dementia), MoCA-B total score and domain/subtest scores, MMSE total score and domain scores, CDR global score, comorbidity status, marital status, and family history of dementia. No direct identifiers (e.g., name, national ID, address, exact dates) will be shared; a data dictionary/codebook will accompany the dataset.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 6 months after publication and ending 24 months after publication.
Access Criteria
Veriler, makul bir talep üzerine paylaşılacaktır. Talepte bulunanların metodolojik olarak sağlam bir öneri sunmaları ve çalışma ekibinden onay almaları gerekmektedir. Erişim, imzalı bir veri kullanım sözleşmesi gerektirecektir. Veriler, kimliksizleştirilmiş biçimde sağlanacaktır.
More information

Locations