Table 2.
Baseline demographic and clinical characteristics by region
| 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 |
AD Alzheimer’s disease, ADAS-Cog Alzheimer’s Disease Assessment Scale—Cognitive subscale, ADCS-ADL23 Alzheimer’s Disease Cooperative Study—Activities of Daily Living, 23-item version, ADCS-CGIC Alzheimer’s Disease Cooperative Study—Clinical Global Impression of Change, APOE apolipoprotein E, BMI body mass index, ChEI cholinesterase inhibitor, IQR interquartile range, MMSE Mini–Mental State Examination, NPI Neuropsychiatric Inventory, SD standard deviation
aNot reported for an additional one patient in this region
bNumber of APOE ε4 carriers/total number of patients with an APOE ε4 measurement
cDonepezil-treated patients only