title: Phase 3 solanezumab trials: Secondary outcomes in mild Alzheimer's disease patients.
abstract: BACKGROUND
  EXPEDITION 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.
  
  
  METHODS
  Secondary analyses of efficacy, biomarker, and safety endpoints in the pooled (EXPEDTION + EXPEDITION2) mild AD population were performed.
  
  
  RESULTS
  In 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.
  
  
  CONCLUSIONS
  These 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.
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA. Electronic address: siemers_eric_r@lilly.com.
authors.forename: Eric R
authors.initials: ER
authors.lastname: Siemers
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Karen L
authors.initials: KL
authors.lastname: Sundell
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Carlson
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Case
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Gopalan
authors.initials: G
authors.lastname: Sethuraman
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Hong
authors.initials: H
authors.lastname: Liu-Seifert
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Sherie A
authors.initials: SA
authors.lastname: Dowsett
authors.affiliation: Avid Radiopharmaceuticals, Philadelphia PA, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Pontecorvo
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Dean
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Ronald
authors.initials: R
authors.lastname: Demattos
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000097:blood / Q000134:cerebrospinal fluid / Q000188:drug therapy*; D016229:Amyloid beta-Peptides / Q000097:blood / Q000134:cerebrospinal fluid; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood / Q000134:cerebrospinal fluid; D003071:Cognition / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009483:Neuropsychological Tests / Q000706:statistics & numerical data*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D016229:Amyloid beta-Peptides; D061067:Antibodies, Monoclonal, Humanized; D015415:Biomarkers; C550616:solanezumab
keywords: Amyloid-β peptide; Clinical trial; Cognition; EXPEDITION; Function; LZAM; LZAN; Mild Alzheimer's disease; Monoclonal antibody; Phase 3; Safety; Solanezumab; Target engagement