Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled, confirmatory phase III trial

Table 3 Mean changes in Mini-Mental State Examination (MMSE) scores from baseline (LOCF) ^a

	Group	n	Mean ± SE ^b	Difference from placebo group ^b (95% CI)	P- value
FAS-LOCF	Placebo	44	0.6 ± 0.5	–	–
	5 mg	43	1.4 ± 0.5	0.8 (−0.5, 2.1)	0.232
	10 mg	49	2.2 ± 0.4	1.6 (0.3, 2.8)	0.016^c
FAS-OC	Placebo	37	1.0 ± 0.5	–	–
	5 mg	32	2.2 ± 0.5	1.2 (−0.2, 2.7)	0.083
	10 mg	43	2.6 ± 0.4	1.6 (0.3, 2.9)	0.014^c
PPS-LOCF	Placebo	40	0.5 ± 0.5	–	–
	5 mg	34	2.1 ± 0.5	1.6 (0.2, 2.9)	0.025^c
	10 mg	45	2.4 ± 0.4	1.9 (0.6, 3.2)	0.004^c

^aCI, Confidence interval; FAS, Full analysis set; LOCF, Last observation carried forward; MMSE, Mini-Mental State Examination; OC, Observed case; PPS, Per-protocol set. ^bLeast squares mean from analysis of covariance with treatment groups as factors and baseline values as covariates. A positive value of the MMSE change indicates improvement in cognitive function. ^c P <0.05.

ISSN: 1758-9193