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

Table 2 Co–primary endpoints (MMSE and NPI-2 scores) and changes from baseline (FAS LOCF) ^a

	Groups	n	Baseline (week 0) score	Week 12 (LOCF) change
	Groups	n	Mean ± SD	Mean ± SD	P- value ^b
MMSE^c	Placebo	44	20.3 ± 4.2	0.6 ± 3.0
	5 mg	45^d	20.6 ± 4.1	1.4 ± 3.4	0.232
	10 mg	49	20.3 ± 4.8	2.2 ± 2.9	0.016
NPI-2^e	Placebo	44	6.9 ± 4.5	−2.0 ± 4.2
	5 mg	45	6.9 ± 4.5	−1.7 ± 4.3	0.661
	10 mg	49	7.3 ± 4.7	−2.9 ± 4.7	0.391

^aFAS, Full analysis set; LOCF, Last observation carried forward; MMSE, Mini-Mental State Examination; NPI, Neuropsychiatric Inventory. ^bAnalysis of covariance with treatment groups as factors and baseline values as covariates. Significance was defined as P < 0.05. ^cPositive value of the MMSE change indicates an improvement in cognitive function. ^dThe number of patients at week 12 (LOCF) was 43. ^eA negative value of the NPI-2 change indicates an improvement in behavioral and neuropsychiatric symptoms.

ISSN: 1758-9193