Table 3.
Comparison of cognition, activities of daily living, and quality of life questionnaires between the ET-101 and control groups.
| Questionnaire and week | ET-101 (n=49), mean (SD) | Control (n=50), mean (SD) | Change differencea (95% CI) | Linear mixed model (treatment-time interaction) | ||||
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F test (df) | P value | |||
| ADAS-Cog-14b,c | 7.45 (2, 194) | <.001 | ||||||
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Week 12 | 30.3 (7.81) | 30.7 (7.40) | 1.42 (–0.44 to 3.29) |
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Week 24 | 25.8 (9.52) | 30.1 (8.55) | –2.55 (–4.69 to –0.417)d |
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| K-MMSE-IIe | 0.454 (2, 194) | .64 | ||||||
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Week 12 | 24.1 (3.34) | 23.6 (2.82) | –0.377 (–1.38 to 0.631) |
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Week 24 | 23.6 (3.16) | 23.1 (2.74) | –0.386 (–1.47 to 0.703) |
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| CDR-SBb,f | 0.865 (2, 194) | .42 | ||||||
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Week 12 | 1.68 (1.00) | 1.92 (1.04) | 0.130 (–0.111 to 0.372) |
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Week 24 | 1.43 (1.01) | 1.85 (1.02) | –0.055 (–0.381 to 0.272) |
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| ADCOMSb,g | 0.608 (2, 194) | .55 | ||||||
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Week 12 | 0.315 (0.175) | 0.343 (0.154) | 0.024 (–0.014 to 0.062) |
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Week 24 | 0.267 (0.180) | 0.310 (0.161) | 0.008 (–0.044 to 0.060) |
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| DSCh | 0.781 (2, 194) | .46 | ||||||
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Week 12 | 39.1 (14.9) | 34.8 (18.8) | 0.798 (–1.34 to 2.94) |
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Week 24 | 39.0 (14.1) | 33.9 (16.0) | 1.62 (–1.29 to 4.52) |
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| CIBIC-Plusb,i | 0.526 (1, 97) | .47 | ||||||
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Week 12 | 3.84 (0.717) | 4.02 (0.553) | –0.183 (–0.439 to 0.073)j |
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Week 24 | 4.02 (0.433) | 4.10 (0.364) | –0.080 (–0.239 to 0.080)j |
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| ADCS-MCI-ADLk | 1.73 (2, 194) | .18 | ||||||
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Week 12 | 43.3 (5.78) | 40.7 (6.41) | –0.101 (–1.73 to 1.53) |
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Week 24 | 43.2 (5.86) | 41.9 (6.01) | –1.40 to (–3.16 to 0.352) |
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| EQ-5D-3L patient | 0.963 (2, 194) | .38 | ||||||
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Week 12 | 0.925 (0.095) | 0.908 (0.098) | –0.004 (–0.038 to 0.030) |
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Week 24 | 0.920 (0.108) | 0.925 (0.085) | –0.024 (–0.060 to 0.012) |
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| EQ-5D-3L study partner | 1.50 (2, 194) | .23 | ||||||
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Week 12 | 0.924 (0.101) | 0.937 (0.106) | 0.008 (–0.028 to 0.045) |
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Week 24 | 0.926 (0.096) | 0.967 (0.056) | –0.021 (–0.050 to 0.009) |
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| EQ-5D-VASl patient | 0.705 (2, 194) | .50 | ||||||
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Week 12 | 77.5 (15.9) | 75.2 (15.8) | 0.978 (–5.26 to 7.21) |
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Week 24 | 72.3 (15.4) | 67.5 (13.8) | 3.53 (–2.39 to 9.46) |
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| EQ-5D-VAS study partner | 1.92 (2, 194) | .15 | ||||||
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Week 12 | 77.7 (11.6) | 81.6 (13.0) | 1.38 (–4.14 to 6.90) |
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Week 24 | 77.0 (10.7) | 77.2 (12.0) | 5.12 (–0.873 to 11.1) |
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aThe score change from baseline to weeks 12 and 24 in the ET-101 group minus the score change from baseline to weeks 12 and 24 in the control group.
bLower scores represent better performance.
cADAS-Cog-14: Alzheimer’s Disease Assessment Scale-Cognitive Subscale-14.
dP<.05.
eK-MMSE-II: Korean Mini Mental State Examination, 2nd Edition.
fCDR-SB: Clinical Dementia Rating-Sum of Boxes.
gADCOMS: Alzheimer’s Disease Composite Score.
hDSC: Digit Symbol Coding.
iCIBIC-Plus: Clinician Interview–Based Impression of Change Plus Caregiver Input.
jDue to the inability to present mean change, the difference in mean change between the groups was replaced with score differences across time points.
kADCS-MCI-ADL: Alzheimer’s Disease Cooperative Study-Mild Cognitive Impairment-Activities of Daily Living.
lEQ-5D-VAS: EQ-5D-Visual Analogue Scale.