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Table 3 Changes in brain volumes from baseline in ALZ2002 to the end of the double-blind period in ALZ2004, by treatment group (safety analysis set)

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

Dosage

Region

Preclinical AD

MCI due to AD

Double blind week 24

Double blind week 52

Double blind week 24

Double blind week 52

n

Mean (SD)

n

Mean (SD)

n

Mean (SD)

n

Mean (SD)

Placebo

Total hippocampus

6

− 61.183 (152.8617)

4

− 192.691 (286.0535)

23

− 148.955 (110.0055)

16

− 208.173 (139.2326)

Bilateral ventricles

6

1213.479 (1297.2666)

4

2384.305 (1765.8039)

23

1877.688 (1868.2961)

16

2554.255 (1619.2302)

Whole brain

6

− 4513.446 (6744.6900)

4

− 3966.134 (6897.1749)

21

− 5202.949 (5310.6112)

15

− 6398.921 (6057.7712)

10 mg

Total hippocampus

8

− 130.472 (133.3899)

4

− 314.289 (190.6022)

18

−130.601 (100.9252)

16

− 308.766 (198.3581)

Bilateral ventricles

8

1317.472 (1089.6703)

4

3254.365 (1326.9982)

18

1294.812 (1190.6962)

16

3349.908 (2563.2821)

Whole brain

8

− 7197.703 (7409.7046)

4

− 17,698.910 (5463.6862)

17

− 5736.212 (6275.3521)

16

− 10,815.252 (9814.0704)

25 mg

Total hippocampus

5

−12.221 (92.4995)

5

− 129.273 (81.0670)

16

− 122.374 (86.0882)

13

− 235.946 (145.2177)

Bilateral ventricles

5

538.445 (965.7828)

5

1999.089 (1514.6993)

16

1399.116 (1085.9684)

13

2853.589 (1945.9111)

Whole brain

5

− 1144.502 (7511.2280)

5

− 4524.925 (6112.8815)

14

− 6634.464 (5868.5297)

13

−  9624.766 (8707.2218)

  1. All values are changes in regional volume measured by the boundary shift integral (BSI) method, relative to baseline in ALZ2002; units are cubic millimeters