Table 3.
Mean change in clinical endpoints from OLE baseline to OLE week 52 and OLE week 104
| OLE week 52 | OLE week 104 | |||||||
|---|---|---|---|---|---|---|---|---|
| MMSE total score | MR-DBP (n = 25) | MR-DBA (n = 21) | SR (n = 19) | Total (n = 64) | MR-DBP (n = 15) | MR-DBA (n = 11) | SR (n = 12) | Total (n = 38) |
| Baseline value, mean (SD) | 21.56 (4.52) | 19.29 (5.03) | 18.84 (4.83) | 20.07 (4.86) | 22.31 (5.03) | 21.55 (4.18) | 19.58 (4.76) | 21.26 (4.74) |
| Value at visit, mean (SD) | 18.36 (5.08) | 15.80 (5.99) | 16.89 (6.60) | 17.13 (5.85) | 17.20 (7.16) | 15.36 (7.26) | 15.00 (8.26) | 15.97 (7.41) |
| Change from baseline, mean (SD) | − 3.16 (2.81) | − 3.45 (3.63) | − 1.95 (3.34) | − 2.89 (3.25) | − 5.20 (4.39) | − 6.18 (5.34) | − 4.58 (5.26) | − 5.29 (4.87) |
| OLE week 52 change from baseline, mean (SD) | NA | NA | NA | NA | − 2.93 (2.52) | − 4.73 (3.82) | − 2.25 (3.62) | − 3.24 (3.36) |
| ADAS-Cog 11 score | MR-DBP (n = 24) | MR-DBA (n = 19) | SR (n = 19) | Total (n = 62) | MR-DBP (n = 14) | MR-DBA (n = 11) | SR (n = 10) | Total (n = 35) |
| Baseline value, mean (SD) | 20.22 (8.21) | 22.92 (10.83) | 22.88 (7.92) | 21.82 (9.00) | 20.88 (10.20) | 19.18 (10.03) | 21.50 (9.21) | 20.59 (9.64) |
| Value at visit, mean (SD) | 24.39 (9.94) | 28.72 (14.43) | 29.61 (12.06) | 27.32 (12.14) | 28.48 (15.49) | 31.03 (16.61) | 26.63 (8.98) | 28.75 (14.04) |
| Change from baseline, mean (SD) | 4.28 (7.87) | 5.82 (6.44) | 6.74 (8.38) | 5.51 (7.58) | 8.17 (13.21) | 11.85 (10.20) | 7.87 (8.28) | 9.24 (10.89) |
| OLE week 52 change from baseline, mean (SD)a | NA | NA | NA | NA | 1.67 (7.09) | 6.67 (7.78) | 6.19 (9.27) | 4.62 (8.17) |
| CDR-SB score | MR-DBP (n = 24) | MR-DBA (n = 19) | SR (n = 19) | Total (n = 62) | MR-DBP (n = 16) | MR-DBA (n = 11) | SR (n = 12) | Total (n = 39) |
| Baseline value, mean (SD) | 5.04 (2.16) | 5.14 (2.49) | 5.84 (1.72) | 5.30 (2.15) | 4.28 (1.75) | 4.36 (2.18) | 5.25 (2.37) | 4.60 (2.07) |
| Value at visit, mean (SD) | 7.38 (3.02) | 7.50 (4.21) | 7.42 (2.84) | 7.43 (3.32) | 7.06 (3.73) | 7.91 (5.75) | 8.29 (4.29) | 7.68 (4.45) |
| Change from baseline, mean (SD) | 2.08 (2.37) | 2.55 (2.05) | 1.58 (1.73) | 2.07 (2.10) | 2.78 (2.85) | 3.55 (3.90) | 3.04 (2.89) | 3.08 (3.12) |
| OLE week 52 change from baseline, mean (SD)b | NA | NA | NA | NA | 1.39 (1.53) | 1.55 (1.74) | 2.00 (1.72) | 1.64 (1.63) |
an = 12 in SR and total n = 37 at OLE week 104
bn = 14 in MR-DBP and total n = 36 at OLE week 104