Table 2.
ARIA‐E results (Year 2) by titration regimen
| Titration regimen | 1 a | 2 | 3 | 4 | 5 | 6 | 7 |
|---|---|---|---|---|---|---|---|
| study | SR | SR | SR | MR | MR | MR | MR |
| Last dose DB (mg) | 0, 105 | 0, 105, 225 | 225 | 0, 105 | 225 | 0, 105 | 225 |
| Carrier | + | − | + | + | + | − | − |
| Number of individuals | n = 74 | n = 44 | n = 28 | n = 83 | n = 60 | n = 45 | n = 33 |
|
ARIA‐E, proportion (%) predicted proportion based on planned OLE regimen |
20.8 | 11.6 | 39.5 | 39.5 | 51.2 | 13.6 | 18.2 |
|
ARIA‐E, proportion (%) predicted proportion based on dose received in OLE |
19.4 | 10.4 | 38.0 | 32.2 | 46.8 | 12.4 | 16.5 |
|
ARIA‐E, proportion (%) observed in OLE |
36.5 | 13.6 | 17.9 | 34.9 | 38.3 | 22.2 | 24.2 |
|
Predicted vs. observed P value (score test for proportions) |
0.003 | 0.69 | 0.01 | 0.69 | 0.22 | 0.16 | 0.41 |
ARIA‐E, amyloid related imaging abnormality–edema; DB, double‐blind period; MR, Marguerite RoAD; OLE, open‐label extension; SR, SCarlet RoAD.
a
35 patients on placebo; 39 patients on active in DB.