Table II.
Changes in ADAS-cog Scores, CDR-SB Scores (ITT population) and hippocampus volume (MRI–ITT population)
Outcome/group | Baseline | Change from Baseline/Week | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
13 | 26 | 39 | 52 | 65 | 78 | ||||||||||||||||
n | Mean | SD | n | LS Mean | 95% Cl | n | LS Mean | 95% Cl | n | LS Mean | 95% Cl | n | LS Mean | 95% Cl | n | LS Mean | 95% Cl | n | LS Mean | 95% Cl | |
ADAS-cog | |||||||||||||||||||||
Placebo BID | 331 | 22.2 | 8.3 | 326 | 0.8 | 0.2-1.4 | 318 | 2.2 | 1.5-2.9 | 292 | 3.1 | 2.4-3.8 | 284 | 4.8 | 4.0-5.7 | 268 | 5.9 | 5.0-6.9 | 265 | 7.5 | 6.5-8.5 |
100 mg BID | 325 | 22.1 | 8.6 | 322 | 1.1 | 0.6-1.7 | 300 | 1.2 | 0.7-1.8 | 282 | 2.7 | 2.1-3.3 | 279 | 3.8 | 3.2-4.5 | 262 | 5.3 | 4.5-6.0 | 258 | 6.8 | 5.9-7.7 |
150 mg BID | 318 | 21.7 | 8.3 | 316 | 0.8 | 0.2-1.4 | 293 | 1.7 | 1.1-2.3 | 281 | 2.9 | 2.2-3.6 | 267 | 4.1 | 3.3-4.9 | 257 | 5.7 | 4.7-6.6 | 252 | 7.5 | 6.4-8.6 |
CDR-SB | |||||||||||||||||||||
Placebo BID | 336 | 5.8 | 2.8 | 335 | 0.2 | 0.1-0.4 | 322 | 0.7 | 0.5-0.9 | 295 | 1.2 | 1.0-1.4 | 287 | 1.8 | 1.6-2.1 | 270 | 2.2 | 1.9-2.5 | 266 | 2.6 | 2.3-3.0 |
100 mg BID | 327 | 5.7 | 2.6 | 326 | 0.4 | 0.2-0.5 | 301 | 0.7 | 0.5-0.9 | 282 | 1.1 | 0.9-1.3 | 275 | 1.6 | 1.4-1.9 | 260 | 1.9 | 1.7-2.2 | 258 | 2.4 | 2.1-2.8 |
150 mg BID | 320 | 5.7 | 2.5 | 316 | 0.2 | 0.1-0.4 | 294 | 0.6 | 0.4-0.8 | 282 | 1.0 | 0.8-1.3 | 267 | 1.5 | 1.3-1.8 | 254 | 2.0 | 1.7-2.3 | 253 | 2.6 | 2.2-3.0 |
HV [mm3] | |||||||||||||||||||||
Placebo BID | 109 | 3294.4 | 723.4 | 109 | -202.2 | 237.0 | |||||||||||||||
100 mg BID | 103 | 3278.9 | 741.2 | 103 | -210.6 | 237.5 | |||||||||||||||
150 mg BID | 100 | 3405.9 | 702.6 | 100 | -259.7 | 235.0 |
Higher scores on ADAS-cog and CDR-SB indicate greater impairment and LS mean changes from Baseline > 0 indicate deterioration. Hippocampus volume (HV) change < 0 indicates atrophy