Table 1.
Titration regimen | 1 | 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 |
APOEε4 carrier | + | − | + | + | + | − | − |
Number of individuals | n = 6 | n = 2 | n = 6 | n = 19 | n = 10 | n = 10 | n = 8 |
SUVRCFB%, mean predicted change based on planned OLE regimen |
−12.2 | −17.1 | −17.1 | −17.1 | −18.9 | −18.7 | −19.7 |
SUVRCFB%, mean, (SD) predicted change based on dose received in OLE |
−12.2 (1.6) | −10.3 (7.1) | −13.1 (1.1) | −12.3 (5.4) | −15.0 (2.5) | −16.6 (3.0) | −15.4 (3.4) |
SUVRCFB%, mean (SD) observed in OLE |
−9.2 (10.5) | −4.2 (6.3) | −12.7 (11.0) | −12.6 (9.0) | −16.3 (7.5) | −11.2 (9.0) | −14.8 (7.5) |
Predicted vs. observed P value (paired t test) |
0.56 | 0.64 | 0.93 | 0.90 | 0.68 | 0.13 | 0.82 |
APOEε4, apolipoprotein E ε4; DB, double‐blind period; MR, Marguerite RoAD; OLE, open‐label extension; PET, positron emission tomography; PK, pharmacokinetic; SD, standard deviation; SR, SCarlet RoAD; SUVR, standard uptake value ratio; SUVRCFB%, standard uptake value ratio percent change from baseline.