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Safety and effectiveness of donepezil on behavioral symptoms in patients with Alzheimer disease


Carrasco, Manuel Martin, Agüera, Luis, Gil, Pedro, Moríñigo, Angel, Leon, Teresa


Alzheimer Disease And Associated Disorders, Volume: 25, No.: 4, Pages.: 333-340

Year of Publication



The objective of this study was to evaluate the prevalence and treatment responsiveness of neuropsychiatric symptoms in patients with mild to moderately severe Alzheimer disease recruited in a naturalistic treatment setting in Spain. All the patients, who matched the prescribing recommendations for donepezil and were able to participate in the study, received donepezil (5 to 10 mg/d) for 6 months. The primary outcome measure was the incidence of adverse events. Secondary outcome measures were neuropsychiatric function measured by the Neuropsychiatric Inventory (NPI), the Mini-Mental State Evaluation, and caregiver burden measured by the Zarit scale. Five hundred and twenty-nine patients were included of which 455 completed the study. The mean baseline NPI score was 19.1. Sixty-five patients (12.3%) experienced an adverse event. The most frequent adverse events were diarrhea and agitation (<2%). Seventeen patients (3%) presented with a neuropsychiatric adverse event and 11 (2%) patients presented with a neurologic adverse event over the course of the study. NPI scores improved by 34.4% over the course of the study, with all items showing a statistically significant improvement. Mini-Mental State Evaluation scores and Zarit caregiver burden scores also improved by 1.27 points and 5.9 points, respectively. This study showed a low incidence of adverse events accompanied by an improvement in the neuropsychiatric and cognitive functions in patients with mild to moderately severe Alzheimer disease treated with donepezil in a community setting in Spain. Donepezil also reduced caregiver burden.;

Bibtex Citation

@article{Carrasco_2011, doi = {10.1097/wad.0b013e318212ab7a}, url = {}, year = 2011, publisher = {Ovid Technologies (Wolters Kluwer Health)}, volume = {25}, number = {4}, pages = {333--340}, author = {Manuel Martin Carrasco and Luis Agüera and Pedro Gil and Angel Mor{'{i}}{~{n}}igo and Teresa Leon}, title = {Safety and Effectiveness of Donepezil on Behavioral Symptoms in Patients With Alzheimer Disease}, journal = {Alzheimer Disease {&} Associated Disorders} }


adverse, adverse effects, aged, aged, 80 and over, akathisia druginduced, alzheimer disease, chemically induced, diarrhea, donepezil, drug therapy, epidemiology, events, female, humans, indans, male, middle aged, piperidines, prospective studies, psychology, therapeutic use, treatment outcome

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Cohort Study

Type of Outcomes

Behaviour, Carer Burden (instruments measuring burden), Cognition, Other

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

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