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. 2011 Mar 8;7(1):102–111. doi: 10.5114/aoms.2011.20612

Table III.

Change in ADAS-cog and CDR-SB (Adjusted Models – ITT population

Visit / parameter ADAS-Cog CDR-SB
Placebo BID 100 mg BID 150 mg BID Placebo BID 100 mg BID 150 mg BID
(N = 341) (N = 335) (N = 329) (N = 341) (N = 335) (N = 329)
Baseline/n 331 325 318 336 327 320
 Mean (SD) 22.2 (8.3) 22.1 (8.6) 21.7 (8.3) 5.8 (2.8) 5.7 (2.6) 5.7 (2.5)
Week 13/n 297 295 293 302 299 295
 LS  mean change -1.6 -1.2 -1.5 0.2 0.4 0.2
 95% CI -3.2;-0.0 -2.8-0.4 -3.0-0.1 -0.2-0.7 -0.1-0.8 -0.3-0.6
 Difference (%) vs. placebo 0.4 (-25.0) 0.1 (-6.3) 0.2 (100.0) 0.0 (0.0)
 P-value 0.302 0.761 0.314 0.656
Week 26/n 294 277 277 296 281 276
 LS mean change -0.2 -1.0 -0.7 0.8 0.7 0.6
 95% CI -1.8-1.4 -2.6-0.6 -2.3-0.9 0.3-1.2 0.3-1.2 0.2-1.1
 Difference (%) vs.placebo -0.8 (400.0) -0.5 (250.0) -0.1 (-12.5) -0.2 (-25.0)
 P-value 0.065 0.223 0.703 0.276
Week 39/n 265 264 264 268 266 265
 LS mean change 1.0 0.7 0.9 1.2 1.2 1.0
 95% CI -0.7-2.7 -1.0-2.4 -0.8-2.6 0.7-1.7 0.7-1.7 0.5-1.5
 Difference (%) vs.placebo -0.3 (-30.0) -0.1 (-10.0) -0.0 (0.0) -0.2 (-16.7)
 P-value 0.525 0.845 0.721 0.329
Week 52/n 260 259 251 261 258 250
 LS mean change 3.1 2.0 2.3 2.0 1.8 1.7
 95% CI 1.4-4.8 0.4-3.7 0.6-4.0 1.5-2.5 1.3-2.3 1.2-2.2
 Difference (%) vs.placebo -1.1 (-35.5) -0.8 (-25.8) -0.2 (-10.0) -0.3 (-15.0)
 P-value 0.090 0.193 0.335 0.136
Week 65/n 246 243 236 247 244 237
 LS mean change 4.5 3.8 4.2 2.5 2.3 2.3
 95% CI 2.8-6.3 2.1-5.5 2.5-5.9 2.0-3.0 1.8-2.8 1.8-2.8
 Difference (%) vs.placebo -0.7 (-15.6) -0.3 (-6.7) -0.2 (-8.0) -0.2 (-8.0)
 P-value 0.217 0.535 0.280 0.378
Week 78/n 248 242 229 245 243 233
 LS mean change 6.2 5.4 6.3 3.0 2.7 3.0
 95% CI 4.5-7.9 3.6-7.1 4.6-8.0 2.5-3.5 2.2-3.2 2.5;3.5
 Difference (%) vs.placebo -0.8 (-12.9) 0.1 (1.6) -0.3 (-10.0) 0.0 (0.0)
 P-value 0.174 0.873 0.232 0.915

Higher scores on ADAS-cog and CDR-SB indicate greater impairment and LS mean changes from Baseline > 0 indicate deterioration. The following covariates and covariate interactions were retained in the adjusted ANCOVA Models. ADAS-cog: Race, Type of ChEI Used, Age (quartiles), Disease Severity, Vitamin E dose, Antidepressant Use, Genotype, Visit X Disease Severity, Visit X Age (quartiles), and Visit X Memantine Dose. CDR-SB: Cardiovascular Disease, Type of ChEI Used, Disease Severity, Memantine Use, Years of Education (quartiles), Antidepressant Use, Genotype, Vitamin E Use, and Visit X Disease Severity

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