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Table 1 Baseline demographics and clinical characteristics in modified intention-to-treat population

From: NeuroEPO plus (NeuralCIM®) in mild-to-moderate Alzheimer’s clinical syndrome: the ATHENEA randomized clinical trial

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)

  1. 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
  2. ApoE Apolipoprotein E, yr Years, No. Number, IR Interquartile range
  3. aRace was determined by the participants
  4. 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)
  5. cScores on the Global Deterioration Scale (GDS) range from 1 to 7, with higher scores indicating greater impairment