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Table 1 Patient demographics and baseline characteristics a (FAS, N= 138)

From: Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled, confirmatory phase III trial

  

Donepezil

 
 

Placebo

5 mg

10 mg

Overall

Characteristics

( n= 44)

( n= 45)

( n= 49)

( n= 138)

Sex, n (%)

    

  Male

17 (38.6)

20 (44.4)

21 (42.9)

58 (42.0)

  Female

27 (61.4)

25 (55.6)

28 (57.1)

80 (58.0)

Age, yr

77.2 ± 6.1

78.8 ± 5.1

77.7 ± 6.8

77.9 ± 6.1

Weight, kg

50.15 ± 10.75

50.68 ± 9.24

51.72 ± 9.89

50.88 ± 9.92

Duration of dementia, yr

2.0 ± 2.3

2.7 ± 1.8

2.3 ± 1.9

2.3 ± 2.0

History of anti-dementia medication, n (%)

    

  Yes

1 (2.3)

3 (6.7)

4 (8.2)

8 (5.8)

  No

43 (97.7)

42 (93.3)

45 (91.8)

130 (94.2)

Cognitive fluctuation, n (%)

    

  Yes

40 (90.9)

41 (91.1)

46 (93.9)

127 (92.0)

  No

4 (9.1)

4 (8.9)

3 (6.1)

11 (8.0)

Visual hallucinations, n (%)

    

  Yes

42 (95.5)

39 (86.7)

39 (79.6)

120 (87.0)

  No

2 (4.5)

6 (13.3)

10 (20.4)

18 (13.0)

Parkinsonism, n (%)

    

  Yes

38 (86.4)

39 (86.7)

44 (89.8)

121 (87.7)

  No

6 (13.6)

6 (13.3)

5 (10.2)

17 (12.3)

Hoehn and Yahr stage, n (%)

    

  I

4 (9.1)

8 (17.8)

7 (14.3)

19 (13.8)

  II

15 (34.1)

17 (37.8)

19 (38.8)

51 (37.0)

  III

19 (43.2)

14 (31.1)

18 (36.7)

51 (37.0)

MMSE score

20.3 ± 4.2

20.6 ± 4.1

20.3 ± 4.8

20.4 ± 4.3

NPI-2 score

6.9 ± 4.5

6.9 ± 4.5

7.3 ± 4.7

7.1 ± 4.5

NPI-10 score

20.5 ± 15.0

18.9 ± 15.3

16.6 ± 11.7

18.6 ± 14.0

ZBI score

28.4 ± 16.2

28.3 ± 18.5

31.4 ± 17.8

29.4 ± 17.4

  1. aFAS, Full analysis set; MMSE, Mini-Mental State Examination; NPI, Neuropsychiatric Inventory; ZBI, Zarit Caregiver Burden Interview. Values are expressed as mean ± SD, unless otherwise specified.