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


Campbell, Noll L., Dexter, Paul, Perkins, Anthony J., Gao, Sujuan, Li, Lang, Skaar, Todd C., Frame, Amie, Hendrie, Hugh C., Callahan, Chris M., Boustani, Malaz A.


Trials, Volume: 14, Pages.: 125-125

Year of Publication



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: NCT01362686.;

Bibtex Citation

@article{Campbell_2013, doi = {10.1186/1745-6215-14-125}, url = {}, year = 2013, publisher = {Springer Nature}, volume = {14}, number = {1}, pages = {125}, author = {Noll L Campbell and Paul Dexter and Anthony J Perkins and Sujuan Gao and Lang Li and Todd C Skaar and Amie Frame and Hugh C Hendrie and Chris M Callahan and Malaz A Boustani}, title = {Medication adherence and tolerability of Alzheimer�s disease medications: study protocol for a randomized controlled trial}, journal = {Trials} }


adherence, adverse effects, aged, alzheimer disease, brain, cholinesterase inhibitors, clinical protocols, comorbidity, diagnosis, donepezil, drug effects, drug interactions, drug therapy, enzymology, female, galantamine, genetics, humans, indiana, male, medication, medication adherence, memory, middle aged, neuropsychological tests, nootropic agents, pharmacogenetics, pharmacokinetics, polypharmacy, prospective studies, psychology, research design, risk factors, rivastigmine, therapeutic use, time factors, treatment outcome

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

Behaviour, Other


Specialist Dementia Centre Care / Memory Clinic

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime