• Eric R Siemers, Karen L Sundell, Christopher Carlson, Michael Case, Gopalan Sethuraman, Hong Liu-Seifert, Sherie A Dowsett, Michael J Pontecorvo, Robert A Dean, and Ronald Demattos.
• Eli Lilly and Company, Indianapolis, IN, USA. Electronic address: siemers_eric_r@lilly.com.
• Alzheimers Dement. 2016 Feb 1; 12 (2): 110-120.

IntroductionEXPEDITION and EXPEDITION2 were identically designed placebo-controlled phase 3 studies assessing effects of solanezumab, an antiamyloid monoclonal antibody binding soluble amyloid-β peptide, on cognitive and functional decline over 80 weeks in patients with mild-to-moderate Alzheimer's disease (AD). Primary findings for both studies have been published.MethodsSecondary analyses of efficacy, biomarker, and safety endpoints in the pooled (EXPEDTION + EXPEDITION2) mild AD population were performed.ResultsIn the mild AD population, less cognitive and functional decline was observed with solanezumab (n = 659) versus placebo (n = 663), measured by Alzheimer's Disease Assessment Scale Cognitive subscale, Mini-Mental State Examination, and Alzheimer's Disease Cooperative Study-Activities of Daily Living functional scale Instrumental ADLs. Baseline-to-endpoint changes did not differ between treatment groups for Alzheimer's Disease Cooperative Study-Activities of Daily Living functional scale, basic items of the ADCS-ADL, and Clinical Dementia Rating Sum of Boxes. Plasma/cerebrospinal fluid biomarker findings indicated target engagement by solanezumab. Solanezumab demonstrated acceptable safety. Efficacy findings for the moderate AD population are also provided.DiscussionThese findings describe solanezumab effects on efficacy/safety measures in a mild AD population. Another phase 3 study, EXPEDITION3, will investigate solanezumab's effects in a mild AD population.Copyright © 2016 Eli Lilly and Company, Indianapolis, IN. Published by Elsevier Inc. All rights reserved.

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