Delayed-Start Method Shows Early Treatment With Solanezumab Beneficial
Eli Lilly and Company announced results from the Phase 3 study evaluating whether the treatment effect of solanezumab is preserved within a pre-specified amount in patients with mild Alzheimer's disease who received solanezumab earlier in the disease compared to patients who began treatment at a later point.
A total of 1,322 subjects with mild Alzheimer's disease were randomized to either the delayed-start (n=663) or to the early-start (n=659) groups. Of the 1,024 subjects who completed the placebo-controlled period (pooled EXPEDITION and EXPEDITION2), 95.2% (n=975) entered the delayed-start period (EXPEDITION-EXT), and 58.2% of delayed-start (n=286) and 61% of early-start patients (n=295) completed two years in the delayed-start period. Researchers evaluated whether solanezumab has a potential disease-modifying effect by using a delayed-start analysis, to determine if the delayed-start patients caught up with the early-start patients.
Treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period (80 weeks since randomization) were preserved at the primary time point of 108 weeks (28 weeks after the start of EXPEDITION-EXT) within a pre-defined margin. This difference at 108 weeks remained statistically significant. Treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period (80 weeks since randomization) were also preserved at an additional time point of 132 weeks (52 weeks after the start of EXPEDITION-EXT) within a pre-defined margin. This difference at 132 weeks was statistically significant.
Solanezumab is a monoclonal antibody that binds to soluble monomeric forms of amyloid-beta after it is produced, allowing it to be cleared before it clumps together to form beta-amyloid plaques.
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