- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07630688
Validation and Reliability of the Turkish Version of the Montreal Cognitive Assessment-Basic (MoCA-B) in Individuals With Low Educational Level (MoCA-B Turkish)
Turkish Validity and Reliability Study of the MoCA-B Test
연구 개요
상태
상세 설명
The prevalence of dementia is steadily increasing, and recognizing cognitive impairment at an early stage-especially during mild cognitive impairment (MCI), before full diagnostic criteria for dementia are met-is crucial. Cognitive screening tools used in individuals with low educational levels often fail to detect MCI. The illiterate version of the Mini-Mental State Examination (MMSE) is insufficient for identifying MCI and early dementia, resulting in delayed diagnosis. The MoCA-Basic (MoCA-B), adapted for low-educated populations and translated into Turkish, has not undergone a validation and reliability study; therefore, it is not routinely used in clinical practice. This study aimed to evaluate the validity and reliability of the Turkish MoCA- B in detecting MCI and dementia, and to compare its diagnostic performance with the MMSE and the Clinical Dementia Rating (CDR).
This study included 55 patients with MCI, 56 with dementia, and 55 healthy controls (total n=166) who presented to the Dementia and Neurology Clinics of Antalya Training and Research Hospital between January 2024 and November 2025. After a detailed mental status examination, participants underwent MoCA-B, MMSE (illiterate version), and CDR assessments. Internal consistency was measured using Cronbach's alpha, and test-retest reliability using the intraclass correlation coefficient (ICC). Group differences were analyzed with one-way ANOVA and Tukey post hoc testing. Correlations between MoCA-B, MMSE, and CDR were evaluated with Pearson correlation. Diagnostic accuracy was assessed through ROC analyses, and optimal cut- off values were determined using the Youden index.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Muratpaşa
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Antalya, Muratpaşa, 터키 (Türkiye), 07030
- Antalya Training and Research Hospital, Neurology Department, University of Health Sciences (SBÜ), Türkiye
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- Active psychiatric disorders / active psychopathology
- Intracranial mass lesions
- Secondary causes of dementia
- Severe medical conditions affecting cognition
- History of traumatic brain injury
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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제어
건강한 통제
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Dementia
Patients who had dementia
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MCI
Patients who had mild cognitive impairment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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MoCA-B cut off points
기간: at baseline and after 4 weeks (test-retest)
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Calculating cutoff values for dementia and MCI in untrained individuals using the MoCA-B test.
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at baseline and after 4 weeks (test-retest)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Correlations of MoCA-B total score with MMSE and CDR
기간: data were collected between January 2024 and November 2025.
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As a secondary endpoint, Pearson correlation (level of relationship) of the MoCA-B total score with MMSE and/or CDR total scores was evaluated to demonstrate concurrent criterion validity.
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data were collected between January 2024 and November 2025.
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Subdomain-level analyses
기간: Data were collected between January 2024 and November 2025
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The subdomain-level analyses for the MoCA-B test aimed to determine which domains best facilitated diagnostic differentiation by evaluating, using ANOVA and post-hoc tests, whether subtest scores such as executive function, memory, and attention differed significantly between control, HKB, and dementia groups.
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Data were collected between January 2024 and November 2025
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Educational/demographic factors in the use of MoCA-B testing.
기간: Data were collected between January 2024 and November 2025
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The aim of this study was to examine whether the MoCA-B total score and its subgroups are affected not only by disease status but also by characteristics such as years of education, age, gender, marital status, additional illnesses, and family history.
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Data were collected between January 2024 and November 2025
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공동 작업자 및 조사자
수사관
- 연구 의자: Aylin YAMAN, Prof. MD., Antalya Training and Research Hospital, Neurology Department, University of Health Sciences (SBÜ), Türkiye
- 연구 책임자: Ali Rıza GÜNDÜZ, MD, Antalya Training and Research Hospital, Neurology Department, University of Health Sciences (SBÜ), Türkiye
간행물 및 유용한 링크
일반 간행물
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- 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,
- 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.
유용한 링크
- Güngen, C., Ertan, T., Eker, E., Yaşar, R., & Engin, F. (2002). Standardize Mini Mental Test'in Türk Toplumunda Hafif Demans Tanısında Geçerlik ve Güvenilirliği. Türk Psikiyatri Dergisi, 13(4), 273-281.
- Official data from the Turkish Statistical Institute's research on the profile of the elderly in Türkiye.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2024-018
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .