Table 1.

Results from a randomised, double-blind, placebo-controlled trial of 1195 patients with mild-to-moderate AD: mean changes from baseline at week 24 for primary and secondary outcome measures, by double-blind treatment group (9.5 mg/24 h rivastigmine patch, capsule and placebo groups), together with incidences of nausea and vomiting (19)

	Mean 24-week change from baseline
	9.5 mg/24 h patch	Capsule (3–12 mg/day)	Placebo
Primary outcomes
ADAS-cog	−0.6**	−0.6**	1.0
ADCS-CGIC	3.9**	3.9**	4.2
Secondary outcomes
MMSE	1.1**	0.8**	0.0
ADCS-ADL	−0.1**	−0.5*	−2.3
Trail making test part A	−12.3***	−9.8***	7.7
Adverse events, %
Nausea	7.2	23.1***	5.0
Vomiting	6.2	17.0***	3.3

ITT-LOCF population. MMSE, Mini-Mental State Examination; ADAS-cog, cognitive subscale of the Alzheimer’s Disease Assessment Scale; ADCS-ADL, Alzheimer’s Disease Cooperative Study Activities of Daily Living scale; ADCS-CGIC, Alzheimer’s Disease Cooperative Study Clinical Global Impression of Change. Negative change scores on ADAS-cog and Trail Making Test part A indicate improvement. Negative change scores on MMSE and ADCS-ADL indicate deterioration. ADCS-CGIC is scored as a judgement of change, with 4.0 indicating no change, < 4.0 indicating improvement and > 4.0 indicating deterioration. *p ≤ 0.05, **p ≤ 0.01, ***p ≤ 0.001 vs. placebo; p-values for ADAS-cog, ADCS-ADL and Trail Making Test part A are derived from two-way ANCOVA (explanatory variables: treatment, country and baseline scores), whereas p-values for ADCS-CGIC and MMSE are derived from the CMH van Elteren test using modified ridit scores with country as the stratification variable.