ITT population (n = 483) | ||||||||
---|---|---|---|---|---|---|---|---|
Negative amyloid blood status (n = 322) | Positive amyloid blood status (n = 161) | |||||||
Omega-3 + MI (n = 94) | Omega-3 (n = 73) | MI (n = 83) | Placebo (n = 72) | Omega-3 + MI (n = 35) | Omega-3 (n = 39) | MI (n = 37) | Placebo (n = 50) | |
Subject characteristics | ||||||||
Male gender, N (%) | 40 (42.55) | 27 (36.99) | 26 (31.33) | 24 (33.33) | 20 (57.14) | 20 (51.28) | 18 (48.65) | 22 (44.00) |
Age in years, mean (SD) | 75.97 (4.77) | 75.52 (4.64) | 75.08 (4.44) | 75.11 (3.96) | 76.69 (4.78) | 77.23 (4.45) | 75.30 (4.52) | 76.54 (4.69) |
Education, N (%) | ||||||||
No diploma or primary school certificate | 18 (19.35) | 20 (28.17) | 17 (20.99) | 21 (29.17) | 8 (22.86) | 14 (36.84) | 11 (29.73) | 12 (24.49) |
Secondary education | 35 (37.63) | 19 (26.76) | 27 (33.33) | 16 (22.22) | 14 (40.00) | 15 (39.47) | 15 (40.54) | 17 (34.69) |
High-school diploma | 16 (17.20) | 8 (11.27) | 17 (20.99) | 12 (16.67) | 4 (11.43) | 2 (5.26) | 2 (5.41) | 8 (16.33) |
University level | 24 (25.81) | 24 (33.80) | 20 (24.69) | 23 (31.94) | 9 (25.71) | 7 (18.42) | 9 (24.32) | 12 (24.49) |
APOE ε4 carrier, N (%) | 17 (20.24) | 9 (14.06) | 16 (21.33) | 19 (28.79) | 11 (34.38) | 12 (32.43) | 19 (55.88) | 18 (39.13) |
DHA (μg/g RBC), mean (SD) | 30.08 (7.97) | 29.70 (9.43) | 32.84 (9.76) | 33.34 (10.48) | 28.63 (9.69) | 32.85 (10.20) | 31.24 (10.15) | 31.72 (9.43) |
Plasma Aβ42/40, mean (SD) | 0.12 (0.02) | 0.12 (0.01) | 0.12 (0.01) | 0.12 (0.01) | 0.10 (0.01) | 0.10 (0.01) | 0.10 (0.01) | 0.10 (0.01) |
Cognition | ||||||||
Cognitive composite score, mean (SD) | 0.01 (0.66) | 0.09 (0.60) | 0.06 (0.68) | 0.13 (0.57) | -0.26 (0.90) | -0.10 (0.68) | -0.21 (0.82) | -0.02 (0.57) |
MMSE total score/30, mean (SD) | 28.27 (1.58) | 28.18 (1.61) | 27.95 (1.76) | 28.21 (1.48) | 27.86 (1.54) | 27.72 (1.99) | 27.84 (1.50) | 27.50 (1.64) |
MMSE orientation score/10, mean (SD) | 9.87 (0.42) | 9.88 (0.41) | 9.77 (0.55) | 9.86 (0.39) | 9.57 (0.74) | 9.74 (0.55) | 9.65 (0.68) | 9.82 (0.48) |
CDR score, N (%) | ||||||||
CDR = 0 | 63 (67.02) | 38 (52.05) | 40 (48.19) | 41 (56.94) | 16 (45.71) | 19 (48.72) | 19 (51.35) | 20 (40.00) |
CDR = 0.5 | 31 (32.98) | 35 (47.95) | 43 (51.81) | 31 (43.06) | 19 (54.29) | 20 (51.28) | 18 (48.65) | 30 (60.00) |
FCSRT scores, mean (SD) | ||||||||
Free recall/48 | 26.87 (6.76) | 27.51 (6.04) | 27.24 (7.66) | 27.43 (6.22) | 25.20 (7.82) | 27.33 (6.78) | 24.41 (7.76) | 25.92 (6.64) |
Total recall/48 | 44.38 (4.33) | 45.63 (3.27) | 44.80 (4.76) | 45.35 (3.41) | 43.91 (4.61) | 44.87 (4.37) | 44.57 (4.01) | 44.78 (4.46) |
Delayed free recall/16 | 10.40 (2.83) | 10.74 (2.72) | 10.47 (3.11) | 10.65 (3.00) | 9.40 (3.94) | 10.21 (3.18) | 9.38 (3.62) | 10.04 (2.88) |
Delayed total recall/16 | 15.19 (1.53) | 15.42 (1.18) | 15.29 (1.70) | 15.46 (1.06) | 14.74 (1.87) | 15.36 (1.09) | 14.92 (1.46) | 15.28 (1.34) |
TMT A, mean (SD) | 49.87 (17.93) | 49.51 (22.23) | 46.82 (19.14) | 46.18 (17.73) | 48.14 (19.74) | 47.41 (13.44) | 51.11 (20.93) | 44.10 (10.56) |
TMT B, mean (SD) | 128.86 (56.53) | 129.40 (72.96) | 114.72 (46.86) | 112.30 (39.45) | 139.94 (104.15) | 134.05 (52.82) | 131.53 (68.08) | 116.32 (40.36) |
Code test score, mean (SD) | 36.29 (9.58) | 35.92 (10.20) | 37.81 (10.52) | 37.92 (9.32) | 35.40 (9.14) | 34.28 (9.58) | 35.19 (11.58) | 36.28 (7.86) |
COWAT score, mean (SD) | 19.37 (6.22) | 19.34 (6.90) | 19.47 (6.75) | 20.15 (6.68) | 19.63 (7.50) | 18.72 (5.69) | 18.89 (6.11) | 18.76 (5.91) |
CNT score, mean (SD) | 24.78 (7.19) | 25.95 (7.27) | 26.20 (7.93) | 26.15 (6.95) | 23.54 (8.40) | 24.31 (7.43) | 24.08 (7.05) | 25.16 (6.72) |
Other measures | ||||||||
ADCS-ADL PI /45; mean (SD) | 39.16 (4.63) | 39.03 (5.26) | 39.17 (5.06) | 38.54 (6.05) | 38.68 (4.35) | 39.49 (5.27) | 39.51 (5.42) | 39.72 (4.35) |
GDS, mean (SD) | 2.92 (2.41) | 3.08 (2.86) | 3.57 (2.94) | 3.01 (2.88) | 2.57 (1.97) | 3.23 (2.56) | 2.81 (2.15) | 3.08 (2.33) |
SPPB, mean (SD) | 10.50 (1.53) | 10.65 (1.72) | 10.28 (1.74) | 10.59 (1.55) | 10.60 (1.63) | 10.23 (1.31) | 11.11 (1.37) | 10.43 (1.65) |
3-year adherence ≥ 75%, N (%) | 51 (54.26) | 58 (84.06) | 40 (48.19) | 59 (89.39) | 19 (55.88) | 30 (93.75) | 19 (52.78) | 38 (82.61) |