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. 2016 Dec 13:6:82-90.
doi: 10.1016/j.dadm.2016.11.004. eCollection 2017.

Assessing quality of life in Alzheimer's disease: Implications for clinical trials

Kristin Kahle-Wrobleski  1 , Wenyu Ye  2 , David Henley  1 , Ann Marie Hake  3 , Eric Siemers  3 , Yun-Fei Chen  2 , Hong Liu-Seifert  2
Affiliations

Assessing quality of life in Alzheimer's disease: Implications for clinical trials

Kristin Kahle-Wrobleski et al. Alzheimers Dement (Amst). .

Abstract

Introduction: 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.

Discussion: Further investigations are needed to determine the optimal measures with which to quantify and qualify QOL of patients with mild AD.

Keywords: Alzheimer's disease; Caregiver-assessed; Clinical trial; Patient-assessed; Quality of life; Solanezumab.

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Figures

Fig. 1
Fig. 1
MMRM analysis* of change from baseline to post-baseline visits in (A) patient-assessed, (B) caregiver-assessed, and (C) weighted (QOL-AD) scores for patients with mild Alzheimer's disease. *The MMRM model evaluated longitudinal treatment effects of solanezumab or placebo on the change from baseline in QOL-AD. The model included QOL scores at baseline, treatment (solanezumab/placebo), visit (as a repeated measure), treatment-by-visit interaction, and the baseline covariates age, sex, number of comorbidities, previous depression (yes/no), concomitant AD medication (acetylcholinesterase inhibitor or memantine) use (yes/no), caregiver age, sex and type, region, whether patient lived alone, time since AD diagnosis, and time since AD onset. †P < .05 for statistically significant difference in the solanezumab group versus the placebo group in patient-assessed QOL-AD at 80 weeks. Abbreviations: AD, Alzheimer's disease; MMRM, mixed model repeated measures; QOL-AD, quality of life in Alzheimer's disease scale.
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