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• W1713204024 abstract "OBJECTIVE: Compare delayed- and early-start treatment to test hypothesis of disease-modifying effect of solanezumab. BACKGROUND: Currently, no Alzheimer9s disease (AD) treatments are thought to slow underlying disease progression. One method to evaluate effect on disease progression is a delayed-start design: a placebo-controlled period followed by a delayed-start period when all patients receive active treatment. DESIGN/METHODS: EXPEDITION and EXPEDITION2 were Phase 3, 18-month, placebo-controlled studies investigating solanezumab. EXPEDITION-ext is an open-label extension study in patients who completed EXPEDITION or EXPEDITION2. In EXPEDITION-ext, all patients receive solanezumab. Patients and site personnel remain blinded to original treatment assignment. We used a new statistical methodology to test hypothesis of disease-modifying effect using a noninferiority test of treatment differences at the delayed-start end compared with the placebo-controlled period end using data from mild AD patients through 28 weeks of treatment in EXPEDITION-ext. RESULTS: Treatment differences between solanezumab and placebo at 28 weeks in EXPEDITION-ext (Δ 2 ) were 2.20 (p=.011) for ADAS-Cog 14 and 1.04 (p=.188) for ADCS-iADL, similar to differences at the beginning of the delayed-start period (Δ 1 ) (ADAS-Cog 14 : 2.01, p=.002; ADCS-iADL: 1.17, p=.027). For ADAS-Cog 14 , the lower limit of the 90[percnt] CI for Δ 2 − 50[percnt] × Δ 1 was 0.3697; thus, noninferiority was met, indicating treatment difference in cognition at end of the placebo-controlled studies was preserved at end of delayed-start period within a pre-defined margin. Noninferiority was not met for instrumental function. CONCLUSIONS: Results from 28 weeks’ treatment in EXPEDITION-ext suggest patients who received solanezumab during the double-blind studies had a cognitive benefit not recovered by patients who began solanezumab later in EXPEDITION-ext. This is thought consistent with a treatment effect that changes the underlying pathology of AD. Another interim analysis with more patients at 6 months and including 2 years of treatment in EXPEDITION-ext is planned. Study Supported by: Eli Lilly Disclosure: Dr. Liu-Seifert has received personal compensation for activities with Eli Lilly & Company as an employee. Dr. Andersen has received personal compensation for activities with Eli Lilly and Company as an employee. Dr. Andersen hold stock and/or stock options in Eli Lilly and Company. Dr. Holdridge has received personal compensation for activities with Eli Lilly & Company as an employee. Dr. Siemers has received personal compensation for activities with Eli Lilly & Company as an employee." @default.
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• W1713204024 date "2015-04-06" @default.
• W1713204024 modified "2023-09-25" @default.
• W1713204024 title "Delayed-Start Analyses of Solanezumab Phase 3 Studies in Mild Alzheimer’s Disease (P7.108)" @default.
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