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Table 6 Incidence of treatment-emergent abnormal value of ALT or AST

From: Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer’s disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study

Study

ALZ2002

ALZ2004

Period

Double-blind

Double-blind

Open-label

Treatment group

Placebo

Ata 10 mg

Ata 50 mg

Placebo

Ata 10 mg

Ata 25 mg

Placebo/5 mg

Placebo/25 mg

5 mg

25 mg

AST or ALT,n

39

34

37

35

29

26

15

14

26

22

> ULN to ≤ 2× ULN,n(%)

0

5 (14.7)

8 (21.6)

2 (5.7)

1 (3.4)

7 (26.9)

4 (26.7)

2 (14.3)

3 (11.5)

7 (31.8)

> 2× ULN to ≤ 3× ULN,n(%)

0

2 (5.9)

1 (2.7)

0

2 (6.9)

1 (3.8)

0

2 (14.3)

0

0

> 3× ULN,n(%)

1 (2.6)

2 (5.9)

2 (5.4)

0

2 (6.9)

1 (3.8)

1 (6.7)

3 (21.4)

0

0

  1. ALT alanine aminotransferase, AST aspartate aminotransferase, ULN upper limit of normal
  2. For double-blind period 1, baseline is defined as the pre-dose baseline value from the preceding parent ALZ2002 study. For open-label period 2, baseline is defined as the last value taken on or before the day of the first dose of study drug in the open-label period
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Alzheimer's Research & Therapy

ISSN: 1758-9193