Table 2.
Demographic and baseline characteristics (intention-to-treat population).
| Cohort 1 with ACI-35.030 | |||||
|---|---|---|---|---|---|
| Characteristic | ACI-35.030 300 μg (N = 6) | ACI-35.030 900 μg (N = 19) | ACI-35.030 1800 μg (N = 6) | Cohort 1 placebo (N = 10) | Total (N = 41) |
| Sex [n (%)] | |||||
| Female | 4 (66.7) | 9 (47.4) | 2 (33.3) | 5 (50.0) | 20 (48.8) |
| Male | 2 (33.3) | 10 (52.6) | 4 (66.7) | 5 (50.0) | 21 (51.2) |
| Race [n (%)] | |||||
| White | 6 (100) | 19 (100) | 6 (100) | 10 (100) | 41 (100) |
| Age (years) | |||||
| n | 6 | 19 | 6 | 10 | 41 |
| Mean (SD) | 65.5 (5.01) | 68.0 (6.29) | 64.7 (4.63) | 67.7 (4.60) | 67.1 (5.49) |
| Median (min, max) | 64.5 (61, 75) | 71.0 (51, 75) | 66.5 (56, 68) | 69.0 (60, 75) | 67.0 (51, 75) |
| Q1, Q3 | 62.0, 66.0 | 63.0, 73.0 | 63.0, 68.0 | 66.0, 70.0 | 63.0, 71.0 |
| BMI (kg/m2) | |||||
| n | 6 | 19 | 6 | 10 | 41 |
| Mean (SD) | 26.4 (3.08) | 24.6 (3.46) | 27.8 (7.08) | 25.1 (2.25) | 25.5 (3.91) |
| Median (min, max) | 26.8 (22, 30) | 24.3 (19, 35) | 25.8 (22, 40) | 25.0 (22, 30) | 24.7 (19, 40) |
| Q1, Q3 | 24.0, 28.7 | 22.1, 26.1 | 22.3, 31.1 | 24.2, 26.0 | 23.1, 26.8 |
| Time since initial diagnosis of AD (years) | |||||
| n | 6 | 19 | 6 | 10 | 41 |
| Mean (SD) | 1.2 (0.98) | 1.2 (0.71) | 2.0 (1.10) | 1.9 (2.42) | 1.5 (1.40) |
| Median (min, max) | 1.5 (0, 2) | 1.0 (0, 3) | 2.0 (1, 4) | 1.0 (0, 8) | 1.0 (0, 8) |
| Q1, Q3 | 0.0, 2.0 | 1.0, 2.0 | 1.0, 2.0 | 1.0, 2.0 | 1.0, 2.0 |
| MMSEb | |||||
| n | 6 | 19 | 6 | 10 | 41 |
| Mean (SD) | 27.5 (0.84) | 26.1 (2.02) | 26.0 (2.68) | 26.1 (3.11) | 26.3 (2.29) |
| Median (min, max) | 27.0 (27, 29) | 26.0 (22, 29) | 26.0 (23, 29) | 26.0 (22, 30) | 27.0 (22, 30) |
| Q1, Q3 | 27.0, 28.0 | 25.0, 28.0 | 23.0, 29.0 | 23.0, 29.0 | 25.0, 28.0 |
| CDR baseline global score [n (%)] | |||||
| 0.5 | 0 | 17 (89.5) | 5 (83.3) | 7 (70.0) | 29 (70.7) |
| 1 | 0 | 2 (10.5) | 1 (16.7) | 1 (10.0) | 4 (9.8) |
| Missinga | 6 (100) | 0 | 0 | 2 (20.0) | 8 (19.5) |
| Number (%) of participants with any prior concomitant medications [n (%)] | |||||
| Acetylcholinesterase inhibitors | 5 (83.3) | 9 (47.4) | 3 (50.0) | 5 (50.0) | 22 (53.7) |
| Memantine | 0 | 1 (5.3) | 1 (16.7) | 1 (10.0) | 3 (7.3) |
| Acetylcholinesterase inhibitors and memantine | 0 | 4 (21.1) | 1 (16.7) | 2 (20.0) | 7 (17.1) |
| Neither acetylcholinesterase inhibitors nor memantine | 1 (16.7) | 5 (26.3) | 1 (16.7) | 2 (20.0) | 9 (22.0) |
| APOE genotype at screening | |||||
| E2/E3 | 0 | 1 (5.3) | 1 (16.7) | 0 | 2 (4.9) |
| E3/E3 | 2 (33.3) | 5 (26.3) | 1 (16.7) | 3 (30.0) | 11 (26.8) |
| E3/E4 | 3 (50.0) | 8 (42.1) | 2 (33.3) | 1 (10.0) | 14 (34.1) |
| E4/E4 | 1 (16.7) | 5 (26.3) | 1 (16.7) | 6 (60.0) | 13 (31.7) |
| Missing | 0 | 0 | 1 (16.7) | 0 | 1 (2.4) |
| Cohort 2 with JACI-35.054 | ||||
|---|---|---|---|---|
| Characteristic | JACI-35.054 15 μg (N = 6) | JACI-35.054 60 μg (N = 6) | Cohort 2 placebo (N = 4) | Total (N = 16) |
| Sex [n (%)] | ||||
| Female | 3 (50.0) | 3 (50.0) | 4 (100) | 10 (62.5) |
| Male | 3 (50.0) | 3 (50.0) | 0 | 6 (37.5) |
| Race [n (%)] | ||||
| White | 6 (100) | 6 (100) | 4 (100) | 16 (100) |
| Age (years) | ||||
| n | 6 | 6 | 4 | 16 |
| Mean (SD) | 66.7 (6.22) | 63.0 (4.77) | 68.0 (6.16) | 65.6 (5.73) |
| Median (min, max) | 67.0 (56, 73) | 62.0 (58, 72) | 68.5 (60, 75) | 65.0 (56, 75) |
| Q1, Q3 | 65.0, 72.0 | 61.1, 63.0 | 64.0, 72.0 | 61.1, 70.5 |
| BMI (kg/m2) | ||||
| n | 6 | 6 | 4 | 16 |
| Mean (SD) | 23.2 (3.75) | 26.6 (4.35) | 25.4 (4.31) | 25.0 (4.15) |
| Median (min, max) | 23.4 (19, 28) | 26.5 (21, 32) | 26.2 (20, 30) | 25.6 (19, 32) |
| Q1, Q3 | 19.0, 25.8 | 22.3, 31.1 | 22.4, 28.4 | 21.8, 27.6 |
| Time since initial diagnosis of AD (years) | ||||
| n | 6 | 6 | 4 | 16 |
| Mean (SD) | 0.7 (0.82) | 3.0 (4.05) | 2.3 (3.20) | 1.9 (2.98) |
| Median (min, max) | 0.5 (0, 2) | 1.5 (0, 11) | 1.0 (0, 7) | 1.0 (0, 11) |
| Q1, Q3 | 0.0, 1.0 | 1.0, 3.0 | 0.6, 4.0 | 0.0, 2.0 |
| MMSEb | ||||
| n | 6 | 6 | 4 | 16 |
| Mean (SD) | 28.0 (1.55) | 25.7 (3.61) | 24.5 (2.52) | 26.3 (2.93) |
| Median (min, max) | 28.0 (26, 30) | 24.5 (22, 30) | 24.0 (22, 28) | 26.5 (22, 30) |
| Q1, Q3 | 27.0, 29.0 | 23.0, 30.0 | 23.0, 26.0 | 23.5, 29.0 |
| CDR baseline global score [n (%)] | ||||
| 0.5 | 6 (100) | 5 (83.3) | 3 (75.0) | 14 (87.5) |
| 1 | 0 | 1 (16.7) | 1 (25.0) | 2 (12.5) |
| Missing | 0 | 0 | 0 | 0 |
| Number (%) of participants with any prior concomitant medications [n (%)] | ||||
| Acetylcholinesterase inhibitors | 3 (50.0) | 4 (66.7) | 2 (50.0) | 9 (56.3) |
| Memantine | 0 | 1 (16.7) | 1 (25.0) | 2 (12.5) |
| Acetylcholinesterase inhibitors and memantine | 0 | 0 | 1 (25.0) | 1 (6.3) |
| Neither acetylcholinesterase inhibitors nor memantine | 3 (50.0) | 1 (16.7) | 0 | 4 (25.0) |
| APOE genotype at screening | ||||
| E3/E4 | 2 (33.3) | 2 (33.3) | 2 (50.0) | 6 (37.5) |
| E4/E4 | 3 (50.0) | 4 (66.7) | 2 (50.0) | 9 (56.3) |
| Missing | 1 (16.7) | 0 | 0 | 1 (6.3) |
APOE = apolipoprotein E gene; BMI = body mass index; n = number of participants; Q1/Q3 = first/third quartile; SD = standard deviation.
a
CDR global score was evaluated at screening but recorded in the database only after the corresponding protocol amendment implementation. All 6 participants on ACI-35.030 300 μg (subcohort 1.1) had a CDR Global score of 0.5, while the 2 placebo participants from that sub-cohort had CDR global scores of 0.5 and 1, respectively.
b
MMSE is presented as the total score.