Table 2 Baseline demographics and characteristics of the intention-to-treat study populations
RCT1 | RCT2 | OLE | RCT3 | |||||
|---|---|---|---|---|---|---|---|---|
Characteristics | Control (n = 106) | Active (n = 106) | Control (n = 129) | Active (n = 130) | Control-Active (n = 104) | Active-Active (n = 97) | Control (n = 262) | Active (n = 265) |
Male, n (%) | 52 (49.1) | 54 (50.9) | 64 (49.6) | 68 (52.3) | 52 (50.0) | 51 (52.6) | 127 (48.5) | 126 (47.5) |
Age, yr | 73.3 (7.8) | 74.1 (7.2) | 73.2 (8.4) | 74.4 (6.9) | 73.9 (8.3) | 74.5 (6.8) | 76.9 (8.2) | 76.6 (8.2) |
BMI, kg/m2 | 26.2 (3.5) | 26.2 (4.8) | 26.7 (4.2) | 26.1 (4.1) | 27.3 (4.2) | 26.9 (4.2) | 26.6 (4.6) | 26.2 (4.5) |
Years of education beyond primary school | 6.0 (4.0) | 5.5 (3.9) | 6.0 [0.0–19.0] | 6.0 [0.0–20.0] | 6.7 (4.7) | 6.2 (4.8) | 6.4 (3.5) | 6.7 (3.6) |
Duration of AD since diagnosis, mo | 32 [0–1036]a | 30 [−18 –to 1932]a | 2 [0–88] | 1 [0–70] | 2.0 [0.0–88.0] | 1.0 [0.0–70.0] | 35 (30) | 33 (25) |
Duration of AD medication use, mo | N/A | N/A | N/A | N/A | N/A | N/A | 31 (29) | 29 (23) |
Nutritional supplement use, n (%)b | ||||||||
Vitamins | 6 (5.4) | 4 (3.5) | 12 (9.3) | 11 (8.5) | 7 (6.7) | 8 (8.2) | 104 (40.0) | 112 (42.4) |
Mineral supplements | 9 (8.0) | 15 (13.3) | 12 (9.3) | 7 (5.4) | 10 (9.6) | 4 (4.1) | 50 (19.2) | 46 (17.4) |
General nutrients | 11 (9.8) | 10 (8.8) | 6 (4.7) | 8 (6.2) | 6 (5.8) | 5 (5.2) | 29 (11.2) | 21 (8.0) |
MMSE, total score | 24.0 (2.5) | 23.8 (2.7) | 25.0 (2.8) | 24.9 (2.9) | 25.1 (3.4) | 25.1 (3.3) | 19.4 (3.0) | 19.5 (3.2) |
ApoE ε4 carrier, n (%) | ||||||||
No | – | – | 58 (49.2) | 62 (51.2) | 46 (48.9) | 41 (44.1) | 84 (42.0) | 87 (39.2) |
Yes | – | – | 60 (50.8) | 59 (48.8) | 48 (51.1) | 52 (55.9) | 116 (58.0) | 135 (60.8) |
Unknown | – | – | 11 | 9 | 10 | 4 | 62 | 43 |