Table. Characteristics of the Primary (Device 2) Cohort.
| Characteristic | No. (%) | |||||
|---|---|---|---|---|---|---|
| Blinded phase | Open-label phase | |||||
| Placebo | Insulin | Total | Placebo | Insulin | Total | |
| Participants, No. | 119 | 121 | 240 | 104 | 106 | 210 |
| Sex | ||||||
| Male | 61 (51.3) | 62 (51.2) | 123 (51.3) | 53 (51.0) | 57 (53.8) | 110 (52.4) |
| Female | 58 (48.7) | 59 (48.8) | 117 (48.7) | 51 (49.0) | 49 (46.2) | 100 (47.6) |
| Age, mean (SD), y | 71.1 (6.8) | 70.5 (7.4) | 70.8 (7.1) | 71.0 (7.0) | 70.3 (7.3) | 70.7 (7.2) |
| Education, mean (SD), y | 16.3 (2.9) | 16.1 (2.6) | 16.2 (2.8) | 16.4 (2.8) | 16.1 (2.7) | 16.3 (2.8) |
| Race | ||||||
| American Indian or Alaskan native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 4 (3.4) | 1 (0.8) | 5 (2.1) | 4 (3.8) | 1 (0.9) | 5 (2.4) |
| Black | 6 (5.0) | 3 (2.5) | 9 (3.7) | 4 (3.8) | 2 (1.9) | 6 (2.8) |
| White | 109 (91.6) | 117 (96.7) | 226 (94.2) | 96 (92.3) | 103 (97.2) | 199 (94.8) |
| Ethnicity | ||||||
| Hispanic or Latino | 5 (4.2) | 5 (4.1) | 10 (4.2) | 2 (1.9) | 3 (2.8) | 5 (2.4) |
| Not Hispanic or Latino | 113 (95.0) | 116 (95.9) | 229 (95.4) | 101 (97.1) | 103 (97.2) | 204 (97.1) |
| Unknown or not reported | 1 (0.8) | 0 | 1 (0.4) | 1 (1.0) | 0 | 1 (0.5) |
| Diagnosis | ||||||
| AD | 73 (61.3) | 80 (66.1) | 153 (63.8) | 63 (60.6) | 71 (67.0) | 134 (63.8) |
| MCI | 46 (38.7) | 41 (33.9) | 87 (36.2) | 41 (39.4) | 35 (33.0) | 76 (36.2) |
| AD medications | ||||||
| No | 75 (63.0) | 70 (57.9) | 145 (60.4) | 69 (66.3) | 59 (55.7) | 128 (61.0) |
| Yes | 44 (37.0) | 51 (42.1) | 95 (39.6) | 35 (33.7) | 47 (44.3) | 82 (39.0) |
| APOE ε4 carriage status | ||||||
| No | 42 (35.3) | 42 (34.7) | 84 (35.0) | 39 (37.5) | 34 (32.1) | 73 (34.8) |
| Yes | 77 (64.7) | 79 (65.3) | 156 (65.0) | 65 (62.5) | 72 (67.9) | 137 (65.2) |
| Baseline ADAS-cog-12 score, mean (SD) | 24.73 (7.56) | 25.91 (8.28) | 25.33 (7.94) | 24.07 (7.30) | 25.34 (8.25) | 24.71 (7.80) |
| Screening MMSE score, mean (SD) | 24.84 (2.72) | 24.79 (2.75) | 24.82 (2.73) | 24.93 (2.73) | 24.95 (2.70) | 24.94 (2.71) |
| Baseline NPI score, mean (SD) | 6.67 (9.59) | 7.06 (7.69) | 6.86 (8.68) | 6.47 (9.91) | 7.17 (7.90) | 6.81 (8.96) |
| Baseline ADL-MCI score, mean (SD) | 39.77 (7.07) | 39.17 (7.77) | 39.46 (7.42) | 40.19 (6.85) | 39.09 (7.94) | 39.64 (7.42) |
| Screening CDR-SB score, mean (SD) | 3.35 (1.51) | 3.59 (1.51) | 3.47 (1.51) | 3.31 (1.53) | 3.56 (1.45) | 3.44 (1.49) |
Abbreviations: AD, Alzheimer disease; ADAS-cog-12, Alzheimer Disease Assessment Scale–cognitive subscale 12; ADL-MCI, Activities of Daily Living Scale for Mild Cognitive Impairment; APOE ε4, apolipoprotein E ε4 allele; CDR-SB, Clinical Dementia Rating scale Sum of Boxes; MCI, mild cognitive impairment; MMSE, Mini-Mental State Examination; NPI, Neuropsychiatric Inventory.