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Table 1 Subject characteristics and clinical efficacy assessments

From: A phase Ib multiple ascending dose study of the safety, tolerability, and central nervous system availability of AZD0530 (saracatinib) in Alzheimer’s disease

Variable

Treatment group (dose of AZD0530)

 

Placebo (n = 6)

50 mg (n = 6)

100 mg (n = 6)

125 mg (n = 6)

F   P

Age

72.6 ± 9.5

72.6 ± 4.4

71.5 ± 4.9

4.6 ± 7.9

0.57 † 0.19

Sex

3 F, 3 M

5 F, 1 M

2 F, 4 M

3 F, 3 M

 

Education (years)

15.0 ± 2.8

15.3 ± 2.7

14.3 ± 2.3

16.8 ± 3.4

0.84 † 0.49

Weight (kg)

6.88 ± 12.1

69.7 ± 8.7

79.6 ± 17.9

65.4 ± 10.4

1.37 † 0.28

MMSE, baseline

23.0 ± 4.1

21.8 ± 3.3

22.2 ± 4.6

20.2 ± 2.3

0.63 † 0.60

MMSE, week 4

25.7 ± 3.3

25.3 ± 2.4

22.7 ± 4.0

22.5 ± 3.3

 

MMSE, change

2.7 ± 2.0

3.5 ± 1.9

0.5 ± 3.4

2.3 ± 2.1

2.15 § 0.13

ADAS-cog, baseline

16.7 ± 2.3

20.6 ± 6.7

23.8 ± 4.5

21.6 ± 7.1

1.73 † 0.19

ADAS-cog, week 4

15.2 ± 4.8

18.3 ± 4.5

22.3 ± 8.1

23.0 ± 4.4

 

ADAS-cog, change

−1.6 ± 4.4

−2.3 ± 3.4

−1.4 ± 5.4

1.4 ± 3.2

1.31 § 0.30

ADCS- ADL, baseline

63.5 ± 9.2

68.7 ± 6.8

67.2 ± 6.4

64.8 ± 3.1

0.67 † 0.58

ADCS- ADL, week 4

67.7 ± 10.6

66.5 ± 6.7

68.2 ± 7.6

66.4 ± 4.3

 

ADCS- ADL, change

4.2 ± 5.2

−2.2 ± 4.2

1.0 ± 2.0

1.6 ± 3.4

2.27 ‡ 0.12

CDR-SOB, baseline

5.6 ± 2.2

5.3 ± 1.9

4.8 ± 1.2

5.1 ± 1.8

0.22 † 0.88

CDR-SOB, week 4

5.8 ± 2.4

5.0 ± 1.9

4.8 ± 1.2

5.6 ± 1.9

 

CDR-SOB, change

0.2 ± 0.4

−0.3 ± 0.6

0.0 ± 0.0

0.5 ± 0.4

2.60 ‡ 0.08

NPI, baseline

9.5 ± 11.9

6.5 ± 6.1

3.7 ± 4.3

13.2 ± 10.1

      ¶ 0.37

NPI, week 4

4.0 ± 5.0

7.7 ± 9.1

2.5 ± 3.5

18.0 ± 8.9

 

NPI, change

−5.5 ± 8.4

1.2 ± 5.1

−1.2 ± 4.8

4.8 ± 7.6

      ¶ 0.09

  1. Values are shown as mean ± standard deviation (apart from sex). F and P values are for analysis of covariance, controlling for baseline score. †Analysis of variance. Kruskal-Wallis H test. ‡Analysis of completer subjects only. Week 4 ADCS-ADL and CDR-SOB invalid for subject AZD026, who was residing in skilled nursing facility. §Analysis of all randomized subjects, including AZD026 who discontinued study drug after 9 days; excluding this subject, MMSE change in 125-mg group = 2.8 ± 1.9, F = 2.07, P = 0.140; ADAS-cog change = 1.3 ± 3.5, F = 1.05, P = 0.393; NPI change = 1.8 ± 1.9, P = 0.169, Kruskal-Wallis H test. ADAS-cog, Alzheimer’s Disease Assessment Scale – cognitive subscale; ADCS-ADL, Alzheimer’s Disease Cooperative Study – Activities of Daily Living Inventory; CDR-SOB, Clinical Dementia Rating Scale – Sum of Boxes; F, female; M, male; MMSE, Mini Mental Status Examination; NPI, Neuropsychiatric Inventory.
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Alzheimer's Research & Therapy

ISSN: 1758-9193