Delayed-start methodology shows benefits of early treatment for Alzheimer's disease

Results from a study using a delayed-start method when assessing solanezumab for treatment of Alzheimer’s disease show benefits of an earlier treatment start time.

To assess potential disease-modifying effects of solanezumab (Eli Lilly), researchers randomly assigned 1,322 patients with mild Alzheimer’s disease to treatment at a delayed start (n = 663) or an early start (n = 659).

The current study utilizes data from the phase 3 Expedition, Expedition2 and Expedition-EXT studies, which included an 18-month randomized, double-blind, placebo-controlled period (Expedition and Expedition2) after which a 2-year delayed start period occurred (Expedition-EXT). In Expedition-EXT, patients who received placebo in the previous trials began treatment with solanezumab.

Primary analysis for the current study occurred 108 weeks after the beginning of the placebo-controlled period, or 28 weeks after the beginning of the delayed-start period.

Treatment differences in cognition and function between patients in the early-start group and those in the delayed-start group remained consistent and statistically significant at 108 weeks.

Further, these differences remained consistent and statistically significant at 132 weeks.

“We are particularly excited about these data because this is the first time the delayed-start methodology has been implemented for an Alzheimer's disease clinical trial,” study researcher Hong Liu-Seifert, PhD, of Eli Lilly and Company, said in a press release. “This new analytical method enabled us to assess if solanezumab had an effect that is consistent with slowing progression of disease by modifying the underlying disease progression, which, up until now, has not been studied. These results support the trial design and delayed-start analysis plan of Expedition3, which is expected to have the last patient visit in October 2016.”

Reference:

Liu-Seifert H, et al. Delayed-start of up to 3.5 years in the phase 3 solanezumab expedition program in mild Alzheimer’s disease. Presented at: Alzheimer’s Association International Conference; July 18-23, 2015; Washington, D.C.

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