TABLE A5A.
Linear regression model to investigate whether trials with cognitive/functional composite primary endpoints have larger sample sizes than trials without, among Alzheimer's disease DMT clinical trials
| Sample size | ||
|---|---|---|
| Independent variables | Coefficient | P |
| Intercept | 1075.760 | .251 |
| Has a cognitive/functional composite endpoint | 140.110 ** | .020 |
| AD stage (reference = overt AD) | ||
| Presymptomatic | −822.074 | .390 |
| Prodromal/MCI | −918.275 | .331 |
| FDA registered trial | 288.643 *** | .000 |
| Phase (reference = phase III) | ||
| Phase II/III | −286.396 ** | .032 |
| Phase III/IV | −316.799 *** | .000 |
| DMT status | 240.565 *** | .000 |
| Number of observations | 305 | |
| R‐squared | 0.213 | |
Abbreviations: AD, Alzheimer's disease; CDR‐SB, Clinical Dementia Rating; DMT, disease‐modifying therapy; FDA, Food and Drug Administration; MCI, mild cognitive impairment.
** P < .05, ***P < .01.