Table 1.
Baseline characteristics of the intention-to-treat ancillary amyloid blood MAPT study population (n = 483)
| 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) |
ADCS-ADL Alzheimer’s Disease Cooperative Study–activities of daily living, CDR Clinical Dementia Rating score, CNT Category Naming Test, COWAT Controlled Oral Word Association Test, DHA docosahexaenoic acid, FCSRT Free and Cued Selective Reminding Test, GDS Geriatric Depression Scale, MMSE Mini-Mental State Examination, SPPB Short Physical Performance Battery, TMT Trail Making Test