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Table 1 Demographic and baseline characteristics

From: Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer’s disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial

 

Placebo

(group 1)

GV1001 0.56 mg

(group 2)

GV1001 1.12 mg

(group 3)

Overall

P value

n = 31

n = 33

n = 32

n = 96

 

Age (years)

    

0.821a

 Mean ± SD

70.9 ± 8.9

70.2 ± 9.8

71.6 ± 8.4

70.9 ± 9.0

 

 Median

72.0

73.0

75.0

74.0

 

 Min, Max

56.0, 84.0

56.0, 85.0

56.0, 82.0

56.0, 85.0

 

Sex

    

0.390b

 Male, n (%)

12 (38.7)

10 (30.3)

15 (46.9)

37 (38.5)

 

 Female, n (%)

19 (61.3)

23 (69.7)

17 (53.1)

59 (61.5)

 

Age at AD diagnosis (years)

    

0.671a

 Mean ± SD

67.9 ± 8.6

66.2 ± 8.3

67.8 ± 8.4

67.3 ± 8.4

 

 Median

68.0

66.0

70.0

68.0

 

 Min, Max

54.0, 82.0

53.0, 83.0

50.0, 80.0

50.0, 83.0

 

Years since diagnosis of AD

    

0.415a

 Mean ± SD

3.6 ± 1.7

4.6 ± 3.9

4.4 ± 2.6

4.2 ± 2.9

 

 Median

3.0

3.0

4.0

3.5

 

 Min, Max

1.0, 8.0

0.0, 14.0

1.0, 10.0

0.0, 14.0

 

SIB

    

0.959a

 Mean ± SD

75.9 ± 16.5

77.3 ± 19.7

76.9 ± 20.1

76.7 ± 18.7

 

 Median

81.0

85.0

84.0

83.0

 

 Min, Max

39.0, 97.0

21.0, 97.0

15.0, 96.0

15.0, 97.0

 

K-MMSE

    

0.618a

 Mean ± SD

11.9 ± 4.9

13.1 ± 5.1

12.1 ± 5.3

12.4 ± 5.1

 

 Median

12.0

14.0

13.0

13.0

 

 Min, Max

4.0, 19.0

2.0, 19.0

1.0, 19.0

1.0, 19.0

 

CDR-SOB

    

0.773a

 Mean ± SD

10.1 ± 4.1

9.5 ± 4.4

10.1 ± 4.1

9.9 ± 4.2

 

 Median

10.0

9.5

10.0

10.0

 

 Min, Max

4.0, 18.0

3.0, 22.0

5.0, 23.0

3.0, 23.0

 

NPI

    

0.077a

 Mean ± SD

18.8 ± 14.4

12.5 ± 12.0

22.6 ± 16.7

17.9 ± 15.0

 

 Median

14.0

6.5

18.0

14.0

 

 Min, Max

1.0, 63.0

1.0, 50.0

4.0, 68.0

1.0, 68.0

 

GDS

    

0.294a

 Mean ± SD

5.4 ± 0.5

5.2 ± 0.4

5.3 ± 0.5

5.3 ± 0.5

 

 Median

5.0

5.0

5.0

5.0

 

 Min, Max

5.0, 6.0

5.0, 6.0

5.0, 6.0

5.0, 6.0

 

ADCS-ADL

    

0.141a

 Mean ± SD

32.9 ± 9.9

38.0 ± 10.6

35.8 ± 10.3

35.6 ± 10.4

 

 Median

33.0

41.5

35.5

35.0

 

 Min, Max

12.0, 54.0

10.0, 52.0

14.0, 51.0

10.0, 54.0

 

CIBIS

    

0.741a

 Mean ± SD

4.7 ± 0.9

4.7 ± 0.7

4.8 ± 0.8

4.7 ± 0.8

 

 Median

5.0

5.0

5.0

5.0

 

 Min, Max

3.0, 6.0

3.0, 6.0

3.0, 6.0

3.0, 6.0

 
  1. Abbreviations: AD Alzheimer’s disease, SD standard deviation, SIB Severe Impairment Battery, K-MMSE Korean Mini-Mental State Examination, CDR-SOB Clinical Dementia Rating Scale-Sum of Boxes, NPI Neuropsychiatric Inventory, GDS Global Deterioration Scale, ADCS-ADL Alzheimer’s Disease Cooperative Study-Activities of Daily Living, CIBIS Clinician Interview-Based Impression of Severity
  2. aAnalysis of variance and bchi-square test were used