Table 1.

Baseline demographics and disease characteristics (full ITT population)

	Placebo (n=159)	2 mg RSG XR (n=162)	8 mg RSG XR (n = 156)	10 mg donepezil (n = 76)
Age, years
Mean ± SD	72.5±8.56	71.7±7.91	72.6±8.63	72.9±7.97
Range	50–88	51–87	50–91	52–85
Sex (female:male), %	60:40	64:36	65:35	63:37
Race, %
African American/African heritage	<1	<1	1	4
American Indian or Alaskan Native	<1	<1	1	0
Asian	21	31	24	18
White	77	67	72	75
American Indian or Alaskan Native White	<1	<1	2	3
Ethnicity – Hispanic or Latino (yes:no), %	11:89	8:92	13:87	14:86
Body mass index
Mean ±SD	25.3±4.00	24.3±3.82	24.8±4.21	25.1±3.52
Range	16–37	16–37	14–40	16–33
MMSE score	19.6±4.04	18.9±3.98	19.1±4.64	19.4±4.01
ADAS-Cog score	25.0±10.26	26.3±10.30	25.8±11.40	24.9±9.68
Time since first symptoms, n	158	162	155	76
Time since first symptoms, years
Mean ± SD	4.17±2.72	4.09±3.05	3.83±2.68	3.59±2.35
Min, max	0.6, 19.7	0.4, 29.0	0.6,23.0	0.5,11.4
Time since first diagnosis, n	159	162	155	75
Time since first diagnosis, years
Mean ± SD	1.62±1.76	1.6±1.74	1.66±2.16	1.47±1.53
Min, max	0.1,11.0	0.1,16.0	0.1,22.0	0.1,9.8
Genotype, n
APOE ε4 negative	82 (52%)	84 (52%)	80 (51%)	38 (50%)
ADAS-Cog score	24.5±10.40	26.2±10.44	24.9±10.73	23.3±10.29
All except APOE ε4 homozygotes	144 (91%)	144 (89%)	142 (91%)	68 (89%)
ADAS-Cog score	25.0±10.04	26.7±10.14	25.4±11.54	24.5±9.52
APOE ε4 positive	77 (48%)	78 (48%)	76 (49%)	38 (50%)
Heterozygote (+/-)	62 (39%)	60 (37%)	62 (40%)	30 (39%)
Homozygote (+/+)	15 (9%)	18 (11%)	14 (9%)	8 (11%)

Values denote means ± SD unless stated otherwise. +/- = 1 copy of the ε4 allele; +/+ = 2 copies of the ε4 allele.