Comparing recruitment, retention, and safety reporting among geographic regions in multinational Alzheimer’s disease clinical trials

Grill, Joshua D; Raman, Rema; Ernstrom, Karin; Aisen, Paul; Dowsett, Sherie A; Chen, Yun-Fei; Liu-Seifert, Hong; Hake, Ann Marie; Miller, David S; Doody, Rachelle S; Henley, David B; Cummings, Jeffrey L

doi:10.1186/s13195-015-0122-5

Alzheimer's Research & Therapy

Table 1 Regional demographic and disease-related summaries of the participants at baseline ^a

From: Comparing recruitment, retention, and safety reporting among geographic regions in multinational Alzheimer’s disease clinical trials

	North America	Western Europe	Australia/South Africa	Japan	Asia	Eastern Europe/Russia	South America/Mexico	Total sample
N (%)	1,884 (40.1)	981 (20.9)	237 (5.1)	435 (9.3)	339 (7.2)	408 (8.7)	410 (8.7)	4,694 (100)
Age, yr (mean ± SD)	75.1 ± 8.3^{EE,AS,JP,AU,WE}	71.9 ± 7.8^SA,JP	72.9 ± 7.4^SA,EE,NA	73.4 ± 7.6^SA,NA	72.1 ± 7.6^SA,NA	70.7 ± 7.8^SA,AU,NA	75.4 ± 7.7^{EE,AS,JP,AU,WE}	73.6 ± 8.1
Female sex, n (%)	986 (52.3)^SA,EE,JP	503 (51.3) ^SA,EE,JP	128 (54.0)^SA	276 (63.5)^WE,NA	191 (56.3)	255 (62.5)^WE,NA	279 (68.1)^AU,WE,NA	2,618 (55.8)
Height, cm (mean ± SD)	166.5 ± 10.7^SA,EE,AS,JP	166.1 ± 9.8^SA,EE,AS,JP	166.8 ± 9.7^SA,EE,AS,JP	154.6 ± 8.9^{SA,EE,AS,AU,WE,NA}	158.2 ± 8.6^{EE,JP,AU,WE,NA}	163.4 ± 9.1^{SA,AS,JP,AU,WE,NA}	160.0 ± 9.1^{EE,JP,AU,WE,NA}	163.9 ± 10.7
Weight, kg (mean ± SD)	73.2 ± 15.7^{SA,EE,AS,JP,WE}	70.2 ± 12.7^SA,AS,JP,NA	70.7 ± 13.1^SA,AS,JP	53.1 ± 10.0^{SA,EE,AS,AU,WE,NA}	58.5 ± 9.7^{SA,EE,JP,AU,WE,NA}	68.8 ± 12.6^AS,JP,NA	66.6 ± 12.5^{AS,JP,AU,WE,NA}	68.6 ± 15.0
Body mass index, kg/m² (mean ± SD)	26.3 ± 4.7^AS,JP,WE	25.4 ± 3.8^AS,JP,NA	25.4 ± 4.1^AS,JP	22.1 ± 3.1^{SA,EE,AS,AU,WE,NA}	23.3 ± 3.1^{SA,EE,JP,AU,WE,NA}	25.4 ± 3.8^AS,JP	26.0 ± 4.3^AS,JP	25.4 ± 4.4
Years of education (mean ± SD)	14.1 ± 3.3^{SA,EE,AS,JP,AU,WE}	11.2 ± 4.2^SA,EE,AS,NA	12.1 ± 3.5^SA,AS,WE,NA	11.7 ± 2.7^SA,AS,NA	9.5 ± 4.7^{EE,JP,AU,WE,NA}	11.9 ± 3.8^SA,AS,WE,NA	8.9 ± 4.5^{EE,JP,AU,WE,NA}	12.2 ± 4.1
APOE ε4 genotype carriers, n (%)	1,086 (63.2)^SA,EE,AS,JP	494 (63.3)^SA,EE,AS,JP	149 (63.7)^SA	220 (51.9)^WE,NA	93 (48.4)^WE,NA	191 (51.1)^WE,NA	189 (49.5)^AU,WE,NA	2,422 (59.0)
Years since symptom onset (mean ± SD)	4.8 ± 2.6^EE,AS,JP	4.6 ± 2.5^EE,JP	4.7 ± 2.8^EE,JP	3.7 ± 2.3^{SA,AS,AU,WE,NA}	4.2 ± 2.4^JP,NA	3.9 ± 2.2^SA,AU,WE,NA	4.5 ± 2.4^EE,JP	4.5 ± 2.5
Years since diagnosis (mean ± SD)	2.5 ± 2.1^{EE,AS,JP,AU,WE}	2.1 ± 1.8^EE,JP,NA	2.0 ± 1.8^EE,NA	1.7 ± 1.5^SA,WE,NA	2.0 ± 1.9^SA,EE,NA	1.5 ± 1.5^{SA,AS,AU,WE,NA}	2.4 ± 1.9^EE,AS,JP	2.2 ± 1.9
Proportion taking any anti-AD medication, n (%)	1,677 (89.0) ^EE,AS,AU	902 (92.0)^SA,EE,AS,AU	172 (72.6)^JP,WE,NA	389 (89.4)^AS,AU	274 (80.8)^WE,NA	302 (74.0)^JP,WE,NA	342 (83.4)^WE	4,058 (86.5)
Proportion taking dual anti-AD therapy, n (%)	894 (47.5)^{SA,EE,AS,JP,AU,WE}	147 (15.0)^{SA,AS,JP,AU,NA}	16 (6.8)^SA,JP,WE,NA	3 (0.7)^{SA,EE,AS,AU,WE,NA}	21 (6.2)^{SA,EE,JP,WE,NA}	58 (14.2)^SA,AS,JP,NA	117 (28.5)^{EE,AS,JP,AU,WE,NA}	1,256 (26.8)
Proportion enrolling with spouse study partner, n (%)	1,318 (70.4)^SA,EE,AS	719 (73.7)^SA,EE,AS	178 (75.7)^SA,EE,AS	279 (64.6)^SA,EE,AS	172 (50.9)^JP,AU,WE,NA	163 (40.1)^JP,AU,WE,NA	174 (42.7)^JP,AU,WE,NA	3,003 (64.4)
Proportion enrolling with adult child study partner, n (%)	374 (20.0)	192 (19.7)	36 (15.3)	116 (26.9)	136 (40.2)	203 (49.9)	162 (39.7)	1,219 (26.1)
Proportion enrolling with other study partner, n (%)	179 (9.6)	64 (6.6)	21 (8.9)	37 (8.6)	30 (8.9)	41 (10.1)	72 (17.7)	444 (9.5)

^aSA = P < 0.01 vs South America/Mexico; EE = P < 0.01 vs Eastern Europe/Russia; AS = P < 0.01 vs Asia; JP = P < 0.01 vs Japan; AU = P < 0.01 vs Australia/South Africa; WE = P < 0.01 vs Western Europe; NA = P < 0.01 vs North America; AD = Alzheimer’s disease; APOE = Apolipoprotein E; Dual therapy = treatment with a cholinesterase inhibitor and memantine; SD = Standard deviation.

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ISSN: 1758-9193

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