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Table 1 Baseline patient characteristics of the masitinib 4.5 mg/kg/day and titrated masitinib 6.0 mg/kg/day parallel groups with respective placebo-control arms (FAS population)

From: Masitinib for mild-to-moderate Alzheimer’s disease: results from a randomized, placebo-controlled, phase 3, clinical trial

  

Masitinib 4.5 mg/kg/day parallel group

Titrated masitinib 6.0 mg/kg/day parallel group

M4.5 (n=182)

PBO (n=176)

tM6.0 (n=182)

tPBO (n=91)

Gender

Female [n (%)]

114 (62.6%)

98 (55.7%)

118 (63.4%)

57 (62.6%)

Age (years)

Mean (±SD)

71.9 (±8.3)

71.7 (±8.2)

71.9 (±8.3)

71.2 (±8.1)

 

Median

73.0

73.0

72.0

72.0

 

Range (min–max)

50.0–86.0

50.0–88.0

50.0–88.0

51.0–87.0

 

 >=50–<60 [n (%)]

19 (10.4%)

17 (9.4%)

14 (7.5%)

10 (11.0%)

 

 >=60–<70 [n (%)]

44 (24.0%)

52 (28.9%)

54 (29.0%)

26 (28.6%)

 

 >=70–<80 [n (%)]

82 (44.8%)

76 (42.2%)

78 (41.9%)

41 (45.1%)

 

 ≥ 80 [n (%)]

38 (20.8%)

35 (19.4%)

40 (21.5%)

14 (15.4%)

MMSE

Mean (±SD)

18.8 (±3.7)

18.6 (±3.8)

18.8 (±3.6)

18.7 (±3.7)

 

Median

19.0

19.0

19.0

19.0

 

MMSE [12–20] [n (%)]

119 (65.4%)

115 (65.3%)

123 (66.1%)

57 (62.6%)

 

MMSE [21–25] [n (%)]

63 (34.6%)

61 (34.7%)

63 (33.9%)

34 (37.4%)

ADCS-ADL

Mean (±SD)

51.8 (±15.1)

51.4 (±15.0)

52.4 (±14.8)

53.2 (±13.7)

 

Median

55.0

53.5

54.0

57.0

 

Range (min–max)

13.0–78.0

4.0–77.0

9.0–78.0

18.0–77.0

ADAS-cog

Mean (±SD)

26.1 (±10.1)

25.9 (±9.7)

24.9 (±10.1)

26.2 (±10.6)

 

Median

25.5

24.8

24.3

24.3

 

Range (min–max)

7.2–54.3

9.2–53.0

4.7–57.3

6.8–51.7

CDR

Mean (±SD)

1.3 (±0.6)

1.2 (±0.8)

1.2 (±0.6)

1.1 (±0.6)

 

Median

1

1

1

1

 

Range (min–max)

0.5–3

0.5–3

0–3

0.5–2

  1. M4.5 masitinib treatment-arm from the masitinib 4.5 mg/kg/day parallel group, PBO placebo treatment-arm from the masitinib 4.5 mg/kg/day parallel group, tM6.0 masitinib treatment-arm from the titrated 6.0 mg/kg/day parallel group, tPBO placebo treatment-arm from the titrated 6.0 mg/kg/day parallel group, MMSE Mini-Mental State Examination, ADAS-cog Alzheimer’s Disease Assessment Scale - cognitive subscale, ADCS-ADL Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory scale, CDR Clinical Dementia Rating Scale, SD standard deviation