title: Assessing quality of life in Alzheimer's disease: Implications for clinical trials.
abstract: BACKGROUND
  Characterization of the quality of life (QOL) in Alzheimer's disease (AD) scale within the context of a clinical trial may inform its applicability in future trials.
  
  
  METHODS
  Using data from 1322 patients enrolled in two phase-III studies (EXPEDITION 1 [NCT00905372] and 2 [NCT00904683]) of intravenous solanezumab in outpatients with mild AD dementia, correlations between patient- and caregiver-assessed QOL and between QOL and clinical outcome measures were examined. Longitudinal effects of solanezumab over 80 weeks were explored, controlling for patient and caregiver baseline characteristics.
  
  
  RESULTS
  Caregivers rated patients' QOL worse than did patients themselves. Patients' QOL was correlated, albeit modestly, with clinical/health measures. Patients' QOL changed minimally over 80 weeks, although a treatment effect of solanezumab on QOL was detected.
  
  
  CONCLUSIONS
  Further investigations are needed to determine the optimal measures with which to quantify and qualify QOL of patients with mild AD.
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA; Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Kristin
authors.initials: K
authors.lastname: Kahle-Wrobleski
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Wenyu
authors.initials: W
authors.lastname: Ye
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA; Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: David
authors.initials: D
authors.lastname: Henley
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA; Department of Neurology, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Ann Marie
authors.initials: AM
authors.lastname: Hake
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA; Department of Neurology, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Siemers
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Yun-Fei
authors.initials: YF
authors.lastname: Chen
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Hong
authors.initials: H
authors.lastname: Liu-Seifert
keywords: Alzheimer's disease; Caregiver-assessed; Clinical trial; Patient-assessed; Quality of life; Solanezumab