Table 3.
Change from baseline of first treatment period to baseline visit of second treatment period (test of carry-over from baseline values) | First treatment period: change from baseline visit to week 6 visit | First treatment period: change from baseline visit to week 12 visit | |||||||
---|---|---|---|---|---|---|---|---|---|
Donepezil (n = 8), mean (SD) | Placebo (n = 10), mean (SD) | Difference (95% CI) | Donepezil (n = 8), mean (SD) | Placebo (n = 10), mean (SD) | Difference (95% CI) | Donepezil (n = 8), mean (SD) | Placebo (n = 10), mean (SD) | Difference (95% CI) | |
MMSE | 2.5 (1.4) | −0.2 (1.7) | 2.7 (1.3, 4.0) | 1.0 (3.1) | −1.5 (2.4) | 2.5 (0.1, 5.0) | 1.5 (2.7) | −0.5 (2.4) | 2.0 (−0.1, 4.5) |
Simple calculation | −0.9 (0.7)a | 0.6 (1.1)b | −1.5 (−2.6, –0.8)c | −0.1 (0.7)a | − 0.1 (0.8)b | –0.0 (−0.7, 0.8)c | 0.0 (1.3)a | 0.4 (1.1)b | −0.4 (−1.4, 0.8)c |
Donepezil vs placebo 6-week comparison | Donepezil vs placebo 12-week comparison | ||||||||
Donepezil first (n = 8), mean (SD) | Placebo first (n = 10), mean (SD) | Combined (n = 18), mean (95% CI) | Donepezil first (n = 8), mean (SD) | Placebo first (n = 10), mean (SD) | Combined (n = 18), mean (95% CI) | ||||
Number location | −1.0 (2.2) | −0.9 (1.3) | −0.1 (−1.7, 1.5) | 0.8 (1.8) | 0.2 (1.5) | 0.5 (− 0.1, 1.5) | 0.0 (2.4)a | 0.7 (2.4) | 0.4 (−0.8, 1.4)a |
Letter cancellation | −0 (25)a | 2 (21) | −2 (−22, 19)a | −7 (39) | −3 (15) | −5 (−19, 8) | −14 (35)a | −1 (14) | −8 (−23, 4)a |
Dot counting | −0.3 (1.5)a | −1.0 (2.4)a | 0.7 (−1.4, 2.3)b | 1.3 (1.8) | −0.2 (1.3)a | 0.5 (−0.2, 1.2)a | 1.3 (0.8)a | −0.1 (1.7) | 0.6 (−0.1, 1.1)a |
Digit span | 0.3 (1.5)b | 0.0 (1.3)b | 0.3 (−0.9, 2.0)d | 0.6 (1.9) | 0.1 (1.6) | 0.4 (−0.4, 1.2) | 0.0 (1.0)a | −1 (0.8) | −0.5 (−0.9, −0.1)a |
CI confidence interval, MMSE Mini-Mental State Examination, SD standard deviation
aOne missing value
bTwo missing values
cThree missing values
dFour missing values