Open Access Study protocol

Medication adherence and tolerability of Alzheimer’s disease medications: study protocol for a randomized controlled trial

Noll L Campbell1234*, Paul Dexter35, Anthony J Perkins2, Sujuan Gao235, Lang Li6, Todd C Skaar7, Amie Frame23, Hugh C Hendrie238, Chris M Callahan235 and Malaz A Boustani235

Author Affiliations

1 Department of Pharmacy Practice, Purdue University School of Pharmacy, 410 West 10th Street, West Lafayette, IN, USA

2 Indiana University Center for Aging Research, Indianapolis, IN, USA

3 Regenstrief Institute, Inc., Indianapolis, IN, USA

4 Wishard Health Services, Indianapolis, IN, USA

5 Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA

6 Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA

7 Division of Clinical Pharmacology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA

8 Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA

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Trials 2013, 14:125  doi:10.1186/1745-6215-14-125

Published: 4 May 2013

Abstract

Background

The class of acetylcholinesterase inhibitors (ChEI), including donepezil, rivastigmine, and galantamine, have similar efficacy profiles in patients with mild to moderate Alzheimer’s disease (AD). However, few studies have evaluated adherence to these agents. We sought to prospectively capture the rates and reasons for nonadherence to ChEI and determine factors influencing tolerability and adherence.

Methods/design

We designed a pragmatic randomized clinical trial to evaluate the adherence to ChEIs among older adults with AD. Participants include AD patients receiving care within memory care practices in the greater Indianapolis area. Participants will be followed at 6-week intervals up to 18 weeks to measure the primary outcome of ChEI discontinuation and adherence rates and secondary outcomes of behavioral and psychological symptoms of dementia. The primary outcome will be assessed through two methods, a telephone interview of an informal caregiver and electronic medical record data captured from each healthcare system through a regional health information exchange. The secondary outcome will be measured by the Healthy Aging Brain Care Monitor and the Neuropsychiatric Inventory. In addition, the trial will conduct an exploratory evaluation of the pharmacogenomic signatures for the efficacy and the adverse effect responses to ChEIs. We hypothesized that patient-specific factors, including pharmacogenomics and pharmacokinetic characteristics, may influence the study outcomes.

Discussion

This pragmatic trial will engage a diverse population from multiple memory care practices to evaluate the adherence to and tolerability of ChEIs in a real world setting. Engaging participants from multiple healthcare systems connected through a health information exchange will capture valuable clinical and non-clinical influences on the patterns of utilization and tolerability of a class of medications with a high rate of discontinuation.

Trial Registration

Clinicaltrials.gov: NCT01362686

Keywords:
Dementia; Adherence; Tolerability; Pharmacogenomics