Eastern Europe/Turkey (n = 759) | Western Europe/Israel (n = 709) | USA/Canada (n = 444) | South America/Mexico (n = 361) | Asia (n = 134) | Australia/South Africa (n = 99) | p value across all regions | |
---|---|---|---|---|---|---|---|
Demographics | |||||||
Age (years), mean (SD) | 74.4 (8.2) | 73.6 (8.0) | 74.3 (9.6) | 74.3 (7.7) | 73.3 (7.8) | 73.9 (7.8) | 0.33 |
Female, n (%) | 493 (65.0) | 449 (63.3) | 266 (59.9) | 237 (65.7) | 87 (64.9) | 59 (59.6) | 0.46 |
Height (m), mean (SD) | 1.63 (0.09) | 1.63 (0.10) | 1.64 (0.10) | 1.59 (0.09) | 1.57 (0.09) | 1.63 (0.09) | < 0.0001 |
Weight (kg), mean (SD) | 69.8 (13.2) | 67.9 (12.7) | 71.6 (15.0) | 67.3 (12.2) | 57.6 (9.5) | 71.9 (15.3) | < 0.0001 |
BMI (kg/m2), mean (SD) | 26.1 (4.2) | 25.6 (4.0) | 26.6 (4.9) | 26.5 (4.1) | 23.4 (3.0) | 26.8 (4.8) | < 0.0001 |
Education (years), mean (SD) | 12.0 (3.3) | 10.2 (4.1) | 13.4 (3.3) | 9.2 (4.3) | 9.6 (5.0) | 11.5 (3.0) | < 0.0001 |
Marital status, n (%) | < 0.0001 | ||||||
Married/with partner | 442 (58.2) | 531 (74.9) | 294 (66.2) | 218 (60.4) | 104 (77.6) | 74 (74.7) | |
Widowed | 266 (35.0) | 131 (18.5) | 94 (21.2) | 104 (28.8) | 22 (16.4) | 14 (14.1) | |
Divorced/separated | 36 (4.7) | 27 (3.8) | 38 (8.6) | 23 (6.4) | 7 (5.2) | 8 (8.1) | |
Single | 15 (2.0) | 20 (2.8) | 18 (4.1) | 16 (4.4) | 1 (0.7) | 3 (3.0) | |
Caregiver, n (%) | < 0.0001 | ||||||
Spouse/partner | 316 (41.6) | 464 (65.4) | 257 (57.9) | 149 (41.3) | 74 (55.2) | 62 (62.6) | |
Child | 333 (43.9) | 184 (26.0) | 119 (26.8) | 164 (45.4) | 52 (38.8) | 23 (23.2) | |
Sibling | 14 (1.8) | 22 (3.1) | 16 (3.6) | 9 (2.5) | 2 (1.5) | 1 (1.0) | |
Other family member | 54 (7.1) | 18 (2.5) | 12 (2.7) | 17 (4.7) | 6 (4.5) | 2 (2.0) | |
Friend | 33 (4.3) | 14 (2.0) | 27 (6.1) | 10 (2.8) | 0 (0.0) | 8 (8.1) | |
Other | 9 (1.2) | 6 (0.8)a | 13 (2.9) | 12 (3.3) | 0 (0.0) | 2 (2.0)a | |
APOE ε4 carrier, n/N (%)b | 405/745 (54.4) | 439/696 (63.1) | 239/428 (55.8) | 196/342 (57.3) | 69/134 (51.5) | 75/93 (80.6) | < 0.0001 |
MMSE (screening), mean (SD) | 18.0 (2.9) | 17.1 (2.9) | 17.5 (3.0) | 17.0 (3.0) | 16.9 (2.9) | 17.1 (3.0) | < 0.0001 |
MMSE (baseline), mean (SD) | 18.4 (2.9) | 17.8 (3.3) | 18.4 (3.3) | 17.8 (3.0) | 17.6 (3.2) | 17.9 (3.3) | 0.0003 |
MMSE (change from screening to baseline), mean (SD) | 0.5 (1.9) | 0.7 (2.2) | 0.9 (2.3) | 0.9 (2.1) | 0.7 (2.7) | 0.9 (2.3) | 0.010 |
Clinical characteristics | |||||||
Time since AD diagnosis (years), median (IQR) | 1.30 (0.75–2.49) | 1.58 (0.89–2.82) | 1.90 (0.87–3.61) | 2.02 (1.12–3.39) | 1.39 (0.68–2.92) | 2.20 (1.25–3.66) | < 0.0001 |
Prestudy treatment duration (years), median (IQR) | 1.00 (0.62–1.82) | 1.11 (0.65–2.05) | 1.31 (0.69–2.68) | 1.07 (0.67–1.70) | 1.05 (0.58–2.29) | 1.26 (0.65–2.42) | < 0.0001 |
Previously treated with a ChEI other than donepezil,c n (%) | 18 (2.4) | 55 (7.8) | 28 (6.3) | 24 (6.6) | 9 (6.7) | 5 (5.1) | < 0.0001 |
Previously treated with memantine, n (%) | 57 (7.5) | 38 (5.4) | 89 (20.0) | 65 (18.0) | 11 (8.2) | 1 (1.0) | < 0.0001 |
Clinical rating scale scores, mean (SD) | |||||||
ADAS-Cog | 25.9 (8.6) | 26.7 (7.9) | 24.3 (7.8) | 27.2 (8.0) | 25.7 (7.1) | 25.3 (8.8) | < 0.0001 |
ADCS-CGIC | 3.9 (0.8) | 3.9 (0.7) | 3.8 (0.7) | 3.6 (0.6) | 3.7 (0.8) | 3.8 (0.7) | < 0.0001 |
ADCS-ADL23 | 53.5 (13.7) | 56.3 (12.9) | 58.5 (12.5) | 54.5 (13.2) | 57.7 (10.8) | 56.1 (12.1) | < 0.0001 |
NPI | 10.1 (11.6) | 10.1 (10.8) | 10.2 (11.6) | 10.6 (13.4) | 7.2 (7.7) | 11.7 (12.9) | 0.11 |