Table 3. MCI sample size estimates for structural measures and a clinical measure – without enrichment, and with respect to five enrichment strategies.
Measures | All | Aβ+ | Aβ+Ptau+ | MRI+ | MRI+Aβ+ | MRI+Aβ+Ptau+ |
Entorhinal | 294 [204 456] | 169 [116 279] | 128 [89 207] | 95 [70 141] | 69 [48 114] | 60 [42 100] |
Amygdala | 306 [221 460] | 184 [128 300] | 144 [101 233] | 122 [90 181] | 102 [71 174] | 93 [64 159] |
Hipp | 392 [275 608] | 230 [157 389] | 210 [141 360] | 152 [110 230] | 125 [85 218] | 132 [88 238] |
Parahipp | 403 [276 654] | 238 [159 410] | 195 [132 333] | 149 [107 228] | 118 [80 204] | 117 [79 209] |
Fusiform | 448 [307 723] | 252 [168 432] | 203 [137 346] | 202 [143 320] | 159 [105 291] | 136 [90 249] |
Isthmus cing | 497 [339 810] | 324 [212 586] | 302 [195 560] | 298 [202 504] | 235 [148 470] | 230 [142 472] |
Whole Brain | 563 [345 1091] | 403 [239 851] | 364 [217 773] | 307 [198 559] | 257 [154 554] | 248 [147 548] |
CDR-SB | 583 [416 894] | 336 [228 579] | 313 [209 554] | 284 [201 453] | 246 [161 468] | 234 [151 455] |
The 95% confidence intervals of the estimated sample sizes are shown in brackets. Sample size estimates are those required to detect 25% slowing in the rate of change in MCI (under various enrichment strategies) that is in excess of that seen in Aβ-negative (Aβ−) HCs (N = 58). P-values for selected pair-wise comparisons are in Tables 4 and 5.
Key: All = all MCI participants (no enrichment); Aβ+ = MCI participants who are Aβ-positive at baseline; Aβ+Ptau+ = MCI participants who are both Aβ- and Ptau-positive at baseline; MRI+ = MCI participants who have AD-like atrophy at baseline; MRI+Aβ+ = MCI participants who are Aβ-positive and have AD-like atrophy at baseline; MRI+Aβ+Ptau+ = MCI participants who are simultaneously positive for all three biomarkers; Hipp = Hippocampus; Parahipp = Parahippocampus; cing = cingulate; CDR = clinical dementia rating – sum of boxes score. See text for definition of positive biomarker status classification.