Table 3.
Sample size per treatment arm needed to obtain 20% reduction in the slope, for α = 0.05 and β = 0.2, estimated via a simulation algorithm in MCI patients with abnormal CSF Aβ 1-42 concentration (MCI ABETA+) or positive to hippocampal atrophy (MCI HIPPO+). In both MCI groups, sample size decreased with increasing follow-up time for all biomarkers, irrespective of biomarker assessment frequency, and MR measures required lowest sample size. For all time sets, sample size was higher in MCI HIPPO+ than in MCI ABETA+ group (all biomarkers but hippocampal volume).
| T0-T6-T12-T18-T24 | T0-T6-T12-T18 | T0-T6-T12 | T0-T12-T24 | ||
|---|---|---|---|---|---|
| MCI ABETA+ | ADAS-cog | 568 | >1000 | >1000 | 991 |
| logPALZ | 326 | 507 | >1000 | 343 | |
| HCI | 175 | 263 | 512 | 185 | |
| MetaROI | 562 | 865 | >1000 | 680 | |
| Hipp. volume | 102 | 144 | 282 | 112 | |
| KN-BSI | 46 | 54 | 78 | 48 | |
|
| |||||
| MCI HIPPO+ | ADAS-cog | >1000 | >1000 | >1000 | >1000 |
| logPALZ | 367 | 792 | >1000 | 468 | |
| HCI | 198 | 263 | 532 | 204 | |
| MetaROI | 649 | >1000 | >1000 | 969 | |
| Hipp. volume | 84 | 120 | 188 | 99 | |
| KN-BSI | 77 | 87 | 117 | 85 | |
ADAS-cog=Alzheimer's Disease Assessment Scale-cognitive subscale; logPALZ=log-transformed PMOD Alzheimer score 16; HCI=hypometabolic convergence index 17; MetaROI=FDG-PET summary metric based on meta-analitically derived regions of interest reflecting AD hypometabolism pattern 18; Hipp. volume=hippocampal volume automatically computed by Freesurfer algorithm; KN-BSI=brain atrophy rate measured by KN boundary shift integral technique 21; T0=baseline, Tn=n-month follow-up.