Table 1.
Baseline demographics and clinical characteristics in modified intention-to-treat population
| Characteristic |
NeuroEPO plus 0.5 mg (n = 57) |
NeuroEPO plus 1.0 mg (n = 56) |
Placebo (n = 57) | Total (n = 170) |
|---|---|---|---|---|
| Age median (IR) — yr | 75.0 ± 10.0 | 73.0 ± 10.0 | 74.0 ± 14.0 | 74.0 ± 9.0 |
| Sex — no. (%) | ||||
| Female | 38 (66.7) | 41 (73.2) | 42 (73.7) | 121 (71.2) |
| Male | 19 (33.3) | 15 (26.8) | 15 (26.3) | 49 (28.8) |
| Race — no. (%)a | ||||
| White | 43 (75.4) | 49 (87.5) | 53 (93.0) | 145 (85.3) |
| Black | 6 (10.5) | 2 (3.6) | 0 | 8 (4.7) |
| Mestizo | 8 (14.0) | 5 (8.9) | 4 (7.0) | 17 (10.0) |
| Educational level — no. (%) | ||||
| None | 12 (21.1) | 9 (16.1) | 12 (21.1) | 33 (19.4) |
| Elementary | 17 (29.8) | 20 (35.7) | 15 (26.3) | 52 (30.6) |
| Junior | 9 (15.8) | 13 (23.2) | 16 (28.1) | 38 (22.4) |
| Senior | 8 (14.0) | 13 (23.2) | 8 (14.0) | 29 (17.1) |
| University | 11 (19.3) | 1 (1.8) | 6 (10.5) | 18 (10.6) |
| Time since diagnosis median (IR)— yr | 1.0 ± 2.0 | 1.0 ± 2.0 | 2.0 ± 1.0 | 1.0 ± 2.0 |
| ADAS-Cog11 scoreb median ± IR | 22.0 ± 12.0 | 22.5 ± 14.0 | 23.0 ± 13.0 | 22.0 ± 12.0 |
| Range | 10 to 53 | 10 to 46 | 11 to 47 | 10 to 53 |
| GDS score — no. (%)c | ||||
| 2 | 0 | 1 (1.8) | 1 (1.8) | 2 (1.2) |
| 3 | 31 (54.4) | 25 (44.6) | 26 (45.6) | 82 (48.2) |
| 4 | 25 (43.9) | 26 (46.4) | 27 (47.4) | 78 (45.9) |
| 5 | 1 (1.8) | 4 (7.1) | 3 (5.3) | 8 (4.7) |
| Stage — no. (%) | ||||
| Mild | 37 (64.9) | 32 (57.1) | 36 (63.2) | 105 (61.8) |
| Moderate | 20 (35.1) | 24 (42.9) | 21 (36.8) | 65 (38.2) |
| APOE ε status — no. (%) | ||||
| No. of participants evaluated | (n = 29) | (n = 30) | (n = 34) | (n = 93) |
| Carrier | 16 (55.2) | 16 (53.3) | 12 (35.3) | 44 (47.3) |
| Non-carrier | 13 (44.8) | 14 (46.7) | 22 (64.7) | 49 (52.7) |
The analysis was performed in the modified intention-to-treat population, which included participants with at least one dose of neuroEPO plus or placebo and a baseline measurement based on randomized treatment
ApoE Apolipoprotein E, yr Years, No. Number, IR Interquartile range
aRace was determined by the participants
bScores on the 11-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-Cog11) range from 0 to 70, with higher scores indicating greater impairment (scores were adjusted for age and formal education)
cScores on the Global Deterioration Scale (GDS) range from 1 to 7, with higher scores indicating greater impairment