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Solanezumab Slows Alzheimer’s in Patients With Mild Disease

Trial results support use of ‘delayed-start’ method

 

New study results suggest that the treatment effect of solanezumab (Elil Lilly) was preserved within a prespecified amount in patients with mild Alzheimer’s disease (AD) who received solanezumab earlier in the disease compared with patients who began treatment at a later point. These findings were presented at the Alzheimer’s Association International Conference 2015 in Washington, D.C.

The results support the use of the “delayed-start” method for assessing the potential effects of a treatment on the underlying disease progression of AD. Results from this study are expected to be published online July 22 in Alzheimer’s & Dementia: Translational Research & Clinical Interventions.

The objective of the delayed-start analysis was to assess a possible disease-modifying effect of solanezumab in patients with mild AD. These results were obtained from a prespecified secondary analysis of the phase III EXPEDITION, EXPEDITION2, and EXPEDITION-EXT studies. EXPEDITION and EXPEDITION2 had identical study protocols, which included an 18-month randomized, double-blind, placebo-controlled period, after which a 2-year delayed-start period occurred (EXPEDITION-EXT), in which the placebo-treated patients from the placebo-controlled period began treatment with solanezumab.

The results from EXPEDITION and EXPEDITION2 were pooled, and only patients with mild dementia at the beginning of the study were included in the analysis. During the delayed-start period, the original treatment assignment remained blinded to patients and sites. When considering the placebo-controlled period and the delayed-start period together, all of the patients were randomly assigned to the same active treatment (solanezumab) but were started at different times, resulting in two treatment regimens: early-start and delayed-start. The primary analysis was at 108 weeks after the beginning of the placebo-controlled period (28 weeks after the beginning of the delayed-start period) among the subgroup of patients with mild AD at baseline.

A total of 1,322 subjects with mild AD were randomly assigned 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 61.0% of early-start patients (n = 295) completed 2 years in the delayed-start period.

Treatment differences in cognition and function between the 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 the 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 also statistically significant.

Solanezumab is a monoclonal antibody being studied as a potential therapy for patients with mild AD. The drug binds to soluble monomeric forms of amyloid-beta after the amyloid is produced, allowing it to be cleared before it clumps together to form beta-amyloid plaques.

Source: Eli Lilly; July 22, 2015.

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