原著 - MMSE - J Key words : MMSE - J ADNI - - MMSE - J 2006 Japanese Altzheimer s Disease Neuroimaging Initiative J - ADNI J - ADNI 2 14

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1 原著 MMSE J Key words : MMSE J ADNI MMSE J 2006 Japanese Altzheimer s Disease Neuroimaging Initiative J ADNI J ADNI JADNI J ADNI J ADNI J ADNI v1 JADNI 2010 MMSE J JADNI MMSE J 23/ /MCI National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer s Disease and Related Disorders Association NINCDS/ADRDA the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition DSM IV MRI MMSE J 23/ MMSE J /MCI AD NINCDS/ADRDA DSM IV. MMSE J MMSE J MMSE J ROC 1 J ADNI PI Japanese Journal of Cognitive Neuroscience

2 /24 23/24 24/ MMSE J MMSE J MMSE J MMSE J MMSE J MMSE J ADNI MCI AD % Petersen et al ADNI % 64/ ADNI ADNI Mini Mental State Examination MMSE Marshall F. Folstein Susan E. Folstein Paul R. McHugh 1975 Folstein et al MMSE J Altzheimer s Disease Neuroimaging Initiative ADNI J ADNI MMSE MMSE MMSE MMSE J ADNI JADNI MMSE J JADNI 2010 MMSE J J ADNI JADNI JADNI 2010 Vol. 18 No

3 J ADNI J ADNI 5 J ADNI PI J ADNI JADNI html J ADNI J ADNI hum0043 v1 J ADNI 2014 J ADNI JADNI 2010 MMSE J Mini 170 Japanese Journal of Cognitive Neuroscience

4 Mental LLC, Inc. MMSE Psychological Assessment Resources Inc. MMSE MMSE MMSE J MMSE world back spelling MMSE / world back spelling world back spelling MMSE J 3 J ADNI MMSE J / J ADNI I J ADNI 2010 J ADNI 313 MMSE J MMSE J J ADNI MMSE J MMSE J MCI 5 GDS J GDS J 4 WMS R J 1 2 GDS J 6 WMS R J 1 3 MMSE J 2 WMS R J B MMSE J 1 5 WMS R J WMS R GDS J 1 6 WMS R J WMS R J B 4 8 WMS R J B 2 9 WMS R J WMS R J 4 11 CDR J PET MMSE J Vol. 18 No

5 MMSE J J ADNI 2010 J ADNI GDS J MRI MMSE J version backward repetition version MMSE J MMSE J 23/ /24 Receiver Operating Characteristic Analysis ROC 1 MMSE J JADNI 2010 MMSE J MMSE J 313 t Tukey t Wilcoxon rank sum test Kruskal Wallis test Tukey Bonferroni Wilcoxon rank sum test SD SD % p=0.049, Wilcoxon signed rank test MMSE J 23/24 MMSE 23/24 23 MMSE J 23/24 NL MCI AD MMSE J Probable AD 172 Japanese Journal of Cognitive Neuroscience

6 NINCDS/ADRDA McKhann et al DSM IV NL MCI AD 89 MCI 127 AD 35 MMSE J MMSE J /24 NL/ MCI AD 4 Receiver Operating Characteristic Analysis ROC MMSE J Receiver Operating Characteristic Analysis ROC MCI AD NINCDS/ADRDA DSM IV NL MCI AD 5 MMSE J Cronbach s alpha reliability coefficient Cronbach JADNI 2010 JADNI MCI 46 AD JADNI 2010 MMSE J MMSE J MMSE J ADNI NL MCI AD NINCDS/ADRADA DSM IV MMSE CDR GDS NL/MCI AD MMSE J 23/24 CDR J Vol. 18 No

7 1 MMSE J MMSE J 142 MMSE J JADNI 2010 t F Tukey t Wilcoxon rank sum test Kruskal Wallis test Tukey Bonferroni Wilcoxon rank sum test MMSE back spelling Wilcoxon signed rank test 3 MMSE J 115 MMSE J 6 4 MMSE J 10 Cronbach II MMSE J JADNI NL 89 MCI 127 AD 35 1 MMSE J MMSE J J ADNI 2010 t Tukey : MMSE J Table 1 p= p=0.20 : : p=0.004 t : p= t : 3 F p< Tukey p< JADNI Table 2 t t Wilcoxon rank sum test Kruskal Wallis test Tukey Bonferroni Wilcoxon rank sum test Table 2 Wilcoxon rank sum test Kruskal Wallis test Bonferroni Wilcoxon rank sum test : : p= : p=0.23, Wilcoxon rank sum test : Japanese Journal of Cognitive Neuroscience

8 p= p=0.003, Wilcoxon rank sum test : p<0.0001, Kruskal Wallis test Bonferroni p< p<0.001 t Tukey Table 1 Table 2 MMSE J Table 3 16 χ 2 =22.939, df=2, p<0.0001, Chi squared test Wilcoxon rank sum test Kruskal Wallis test : p=0.013, Wilcoxon rank sum test MMSE J 8 15 p<.0001, Kruskal Wallis test 16 p=0.0012, Kruskal Wallis test : Wilcoxon rank sum test Table 3 Kruskal Wallis test 8 15 p= p= Table 1. Means and SDs of MMSE J scores for 251 subjects by Demogaraphic Characteristics Sex Male Female N p value Backward repetition version M SD Serial 7s version M SD Years of Education 16 y 8 15 y p value N Backward repetition version M SD Serial 7s version M SD Age y y 75 y N p value** Backward repetition version M SD <.0001 > > Serial 7s version M SD <.0001 > > t test, ANOVA Multiple comparison by Tukey s method. p<0.001 Vol. 18 No

9 Table 2. Means and SDs of MMSE J scores for 251 subjects by Demogaraphic Characteristics Sex Male Female N p value Backward repetition version M SD Serial 7s version M SD Years of Education 16 y 8 15 y p value N Backward repetition version M SD Serial 7s version M SD Age y y 75 y N p value Backward repetition version M SD <.0001 > > Serial 7s version M SD <.0001 > > Wilcoxon rank sum test, Kruskal Wallis test Multiple comparison by Wilcoxon rank sum test with Bonferroni correction. p<.001 Table 3. Contingency table by Age and Years of Education for 251 subjects Years of Education Age 8 15 y 16 y Total y y y Total χ 2 test p< % p=0.049, Wilcoxon signed rank test MMSE J MMSE J 23/24 NL+MCI AD 2 MMSE J MMSE J ROC 251 ROC NL/MCI AD MMSE J : ROC / / / / Japanese Journal of Cognitive Neuroscience

10 : ROC 24/ / / / MMSE J Cronbach Cronbach MMSE J MMSE J JADNI NL 57 MCI 46 AD 12 1 MMSE J MMSE J JADNI 2010 t F Tukey Table 4 : MMSE J t p= p=0.24 : t p= p=0.023 : : p< : p<0.002 F Tukey p= p< Table 4. Means and SDs of MMSE J scores by Demogaraphic Characteristics for 115 subjects Sex Male Female N p value Backward repetition version M SD Serial 7s version M SD Years of Education 16 y 8 15 y p value N Backward repetition version M SD Serial 7s version M SD Age y y 75 y N p value Backward repetition version M SD <.0001 > > Serial 7s version M SD t test, ANOVA Multiple comparison by Tukey s method. p<0.001 > > Vol. 18 No

11 Table 5. Means and SDs of MMSE J scores for 115 subjects by Demogaraphic Characteristics Sex Male Female N p value Backward repetition version M SD Serial 7s version M SD Years of Education 16y 8 15y p value N Backward repetition version M SD Serial 7s version M SD Age 60 64y 65 74y 75y N p value Backward repetition version M SD <.0001 > > Serial 7s version M SD <.002 > > Wilcoxon rank sum test, Kruskal Wallis test Multiple comparison by Wilcoxon rank sum test with Bonferroni correction. p<.0001 Multiple comparison by Wilcoxon rank sum test with Bonferroni correction. p< t Wilcoxon rank sum test Kruskal Wallis test Tukey Bonferroni Wilcoxon rank sum test Table 4 : MMSE J Wilcoxon rank sum test p= p=0.25 : Wilcoxon rank sum test p= p=0.029 : Kruskal Wallis test p< p<0.002 Bonferroni Wilcoxon rank sum test p< p<0.01 t Tukey Table 4 Table 5 MMSE J Table 6 χ 2 =14.55, df=2, p=0.0007, Chi squared test Wilcoxon rank sum test Kruskal Wallis test : p=0.008, Wilcoxon rank sum test 8 15 p=0.0009, Kruskal Wallis test 16 p= 178 Japanese Journal of Cognitive Neuroscience

12 Table 6. Contingency table by Age and Years of Education for 115 subjects Age 8 15y 16 y Total y y y Total χ 2 test p= MMSE J Cronbach MMSE J , Kruskal Wallis test : Wilcoxon rank sum test Table p=0.0003, Kruskal Wallis test 16 p=0.0012, Kruskal Wallis test : p= : p=0.8, Wilcoxon signed rank test MMSE J MMSE J 6 test retest % , t=13.94, df=113, p< % , t=11.72, df=113, p< III. 1. MMSE J CDR J WMS R GDS J 4 NL MCI AD MMSE MCI AD NL MCI AD MMSE ADNI MMSE NL MCI AD MMSE MMSE MMSE 23/24 MMSE ADNI MMSE NL MCI AD /MCI AD MMSE J Vol. 18 No

13 251 MMSE J MMSE J Tombaugh and McIntyre / MMSE J 2. MMSE J test retest % , t=11.72, df=113, p< % , t=13.94, df=113, p< MMSE test retest Stuss et al MMSE J back spelling back spelling 4. JADNI MCI AD MCI AD 9.6% ADNI MCI AD % Petersen et al ADNI % 64/ MCI AD MCI 2 ADNI 1 ADNI ADNI MMSE J MMSE J MMSE MMSE J Psychological Assessment Resources Inc. 180 Japanese Journal of Cognitive Neuroscience

14 MMSE MMSE J 2 Psychological Assessment Resources Inc. 1 Folstein MF, Folstein SE, McHugh PR Mini Mental State : A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research 12, JADNI 2010 MMSE J : A preliminary report , MMSE J : J ADNI 2014, 6, tokyo.ac.jp/public/public01_260624_j.html 5 J ADNI tokyo.ac.jp/ja/administration/code ofconduct/pdf/ /f file 1 2.pdf iin.html 7 J ADNI iin.html itunodentatu/daisannsyaiin.html J ADNI J ADNI iin.html JADNI shinjitunodentatu/daisannsyaiin.html JADNI 43 v1 13 McKhann G, et al Clinical diagnosis of Alzheimer s disease : Report of the NINCDS ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer s Disease. Neurology 34, Tombaugh TN, McIntyre NJ The Mini Mental State Examination : A comprehensive review. Journal of the American Geriatrics Society 40 9, Stuss DT, et al Do long tests yield a more accurate diagnosis of dementia than short tests? A comparison of 5 neuropsychological tests. Archives of Neurology 53 10, Petersen RC, Aisen PS, Beckett LA, Donohue MC, Gamst AC, et al Alzheimer s Disease Neuroimaging Initiative ADNI : clinical characterization. Neurology 74 1, JADNI 2013 Vol. 18 No

15 Reexamination of the Validity and Reliability of the Japanese Version of the Mini Mental State Examination MMSE J Morihiro Sugishita 1, Isao Hemmi 2, Tomoko Takeuchi 3 1 Tokyo Metropolitan University, Tokyo, Japan, J ADNI Psychology Core PI 2 Japanese Red Cross College of Nursing, Tokyo, Japan 3 Tsukuba University, Tsukuba, Japan Key words : MMSE, MMSE J, ADNI, dementia, validity, reliability The criterion based validity of the Japanese version of the Mini Mental State Examination MMSE J Sugishita 2006 was preliminarily evaluated in 2010 Sugishita, Hemmi and JADNI 2010 based on data from 313 subjects who participated in the Japanese Alzheimer s Disease Neuroimaging Initiative J ADNI. Test retest reliability was also preliminarily examined in 145 subjects in J ADNI who were tested twice. The second testing was performed 6 months after the first Sugishita, Hemmi and JADNI However, in March, 2012, an employee of a pharmaceutical company reported that the J ADNI data for some subjects had been falsified. In March, 2014, Drs. Sugishita, M and Asada,T reported a total of 105 cases with confirmed or suspected falsification of data or protocol violation 68 cases by Sugishita and 37 cases by Asad to the Special Investigative Committee of the University of Tokyo. In June 20, 2014, the Committee confirmed that data had been inappropriately modified by inappropriate persons. The authors Sugishita & Hemmi of the 2010 paper Sugishita, Hemmi and JADNI 2010 then proposed to withdraw and revise the paper. The editorial board of the Japanese Journal of Cognitive Neuroscience accepted the proposal on June 3, In October 2014, 129 cases with confirmed or suspected falsification of data or protocol violation were reported to the Third Party Panel of the University of Tokyo. The Third Party Panel examined all 129 subjects and found no falsification of data or protocol violations. However, the four written refutations by Dr. M. Sugishita argued against the criticism of the Third Party Panel and it became clear that the Third Party Panel had made errors in judgment cf. Consequently, it is necessary to exclude the subjects with falsification of data or protocol violation from the J ADNI data. However, Dr. T. Iwatsubo the J ADNI principal investigator disclosed under limitations the uncorrected J ADNI data to researchers through the Japan Science and Technology Information Aggregator, Electronic J STAGE in January v1. Therefore, the aim of the present study was to reexamine the validity and reliability of the MMSE J after excluding cases with confirmed or suspected falsification of data or protocol violations. In our previous study Sugishita, Hemmi and JADNI 2010, the criterion based validity of the cut off score of 23/24 for dementia was evaluated in 313 subjects and compared with a medical doctor s classification of the same subjects into two groups a Normal/Mild Cognitive Impairment MCI group and an Alzheimer s Disease AD group based on the criteria of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer s Disease and Related Disorders Association NINCDS/ADRDA and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition DSM IV. In the present study, after excluding 54 subjects with confirmed or suspected falsification of data or protocol violations and 8 subjects with other various reasons 4 with brain MRI abnormality, 3 with low educational level, and 1 with an abnormally high depression scale score, criterion based validity was evaluated in 251 subjects. Criterion based validity was found to be excellent and almost the same as that in our previous study the serial 7s version : sensitivity 0.86, 182 Japanese Journal of Cognitive Neuroscience

16 specificity 0.89, the backward repetition version : sensitivity 0.80, specificity The proximal cut off score for dementia were newly evaluated against the external criteria, namely, the classification the Normal/MCI group and the AD group by the medical doctor based on NINCDS/ADRDA and DSM IV criteria. However, the MMSE J was sometimes tested before the classification of the medical doctor. The medical doctor sometimes knows the MMSE J score, which influence the classification of the medical doctor. Receiver Operating Characteristic Analysis showed that the proximal cut off score for dementia was 23/24 in the serial 7 version, and 23/24 or 24/25 in the backward repetition version. In the previous study, test retest reliability was evaluated in the 142 subjects who were tested twice namely, at screening and at 6 months after screening. In the present study, after excluding 23 cases with confirmed or suspected falsification of data or protocol violations and 4 subjects with other various reasons 2 with low educational level, 1 with suspected brain tumor and 1 with insufficient data, test retest reliability was evaluated in 115 subjects. To assess the test retest reliability of the MMSE J, the Pearson correlation coefficients were calculated. Test retest reliability was found to be excellent 0.74 for the backward repetition version ; 0.80 for the serial 7s version which are almost the same as those of the previous study. The criterion based validity and test retest reliability of the present study were excellent, which indicates that the MMSE J is a clinically applicable screening instrument for dementia. The results of the present study also showed that the backward repetition version had higher scores than the serial 7 version, which means that the former is easier than the latter. In both the present and previous studies, the criterion based validity and the proximal cut off score for dementia were evaluated against external criteria not completely independent from the MMSE J score. In a future study, criterion based validity and the proximal cut off score for dementia should be examined against the external criteria independent from the MMSE J score. US ADNI data showed that the conversion rate of the amnestic type of the MCI to the AD was 16.5% one year after the first examination. However, the J ADNI data revealed that the conversion rate one year and two years after the first examination was extremely high, that is, 29% Asada 2013, which suggests that the J ADNI data is dubious. In a future study whether the extremely high conversion rates are due to a falsification of data, protocol violation or other causes need to be elucidated. As long as these problems remain, it appears that the J ADNI data should not be used for research purposes. Vol. 18 No

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原 著 - MMSE - J Key words : MMSE - J ADNI - - MMSE - J 2006 Japanese Altzheimer s Disease Neuroimaging Initiative J - ADNI J - ADNI 2 14

原著 - MMSE - J Key words : MMSE - J ADNI - - MMSE - J 2006 Japanese Altzheimer s Disease Neuroimaging Initiative J - ADNI J - ADNI 2 14