title: Amyloid-related imaging abnormalities from trials of solanezumab for Alzheimer's disease.
abstract: BACKGROUND
  Solanezumab, a humanized monoclonal antibody that binds soluble amyloid beta peptide, is being developed for treatment of Alzheimer's disease (AD).
  
  
  METHODS
  Patients (n = 2042) with mild and moderate AD were randomized 1:1 to 400-mg solanezumab or placebo infusion every 4 weeks for 80 weeks and 1457 patients entered an open-label extension. Magnetic resonance imaging scans monitored for amyloid-related imaging abnormalities-edema/effusion (ARIA-E) and amyloid-related imaging abnormalities-hemorrhage/hemosiderin deposition.
  
  
  RESULTS
  Sixteen patients (solanezumab, n = 11; placebo, n = 5) developed ARIA-E during the double-blind phase, and 7 patients developed ARIA-E during the open-label extension as of July 31, 2014. Unique cases are discussed including solanezumab patients who were given solanezumab, while ARIA-E was present and a patient who developed ARIA-E during placebo treatment and again during solanezumab treatment.
  
  
  CONCLUSIONS
  Asymptomatic ARIA-E was detected in solanezumab-treated and placebo-treated AD patients. ARIA-E occurs infrequently during solanezumab and placebo treatments but may occur repeatedly in some patients.
authors.affiliation: Lilly Bio-medicines, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Carlson
authors.affiliation: Lilly Bio-medicines, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Siemers
authors.affiliation: Lilly Bio-medicines, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Ann
authors.initials: A
authors.lastname: Hake
authors.affiliation: Lilly Bio-medicines, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Case
authors.affiliation: Neurology, CNS Medical Strategy & Science, Therapeutic Science & Strategy Unit, Quintiles, Durham, NC, USA.
authors.forename: Roza
authors.initials: R
authors.lastname: Hayduk
authors.affiliation: Medical Imaging, Neuroscience, Bioclinica, Newark, CA, USA.
authors.forename: Joyce
authors.initials: J
authors.lastname: Suhy
authors.affiliation: Medical Imaging, Neuroscience, Bioclinica, Newark, CA, USA.
authors.forename: Joonmi
authors.initials: J
authors.lastname: Oh
authors.affiliation: Medical Imaging, Neuroscience, Bioclinica, Newark, CA, USA; Department of Radiology, California Pacific Medical Center, San Francisco, CA, USA.
authors.forename: Jerome
authors.initials: J
authors.lastname: Barakos
keywords: Alzheimer's disease; Amyloid-related imaging abnormalities; Clinical trials