https://orcid.org/0000-0002-4607-7666
Abstract
Purpose
Medication discontinuation for patients with Alzheimer’s dementia (AD) influences treatment efficacy. This study aimed to evaluate the effect of psychoeducational intervention (PI) on donepezil retention rates and identify the factors associated with donepezil continuation in patients with AD.
Patients and Methods
One hundred and seventeen patients with AD were randomly allocated to the PI (n = 58) or standard care (SC; n = 59) groups. All patients were prescribed donepezil for 48 weeks. Primary endpoints were the 48-week donepezil retention rate and the reasons for donepezil discontinuation in the PI and SC groups. The secondary endpoint was the predictive factors, among the baseline clinical variables, for donepezil continuation in all patients.
Results
The donepezil retention rate was 62.1% (36/58) in the PI group and 66.1% (39/59) in the SC group. The most common reason for discontinuation in both groups was adverse events (PI, 12.1%; SC, 10.2%). Logistic regression analysis revealed that the results of the pentagon copying test in the Mini-Mental State Examination administered at baseline was a significant predictor of donepezil continuation for all patients in both the groups (odds ratio: 0.359; 95% confidence interval: 0.154–0.839).
Conclusion
There was no significant difference between the PI and SC groups concerning donepezil retention rate in patients with AD. Our results demonstrate that the pentagon copying test can significantly predict donepezil continuation in patients with AD, indicating that impaired visuospatial and executive functions may reflect medication discontinuation.
Trial Registration
UMIN-CTR:UMIN000012617.
Abbreviations
AD, Alzheimer’s dementia; CI, confidence interval; CNS, central nervous system; DSM, Diagnostic and Statistical Manual of Mental Disorders; FAS, full analysis set; FAST, Functional Assessment Staging Test; MMSE, Mini-Mental State Examination; OR, odds ratio; PI, psychoeducational intervention; PPS, per-protocol set; RCT, randomized clinical trial; SAS, safety analysis set; SC, standard care; TEAE, treatment-emergent adverse event.
Data Sharing Statement
No any data will be shared besides what is included in the manuscript.
Acknowledgments
The authors would like to express many thanks to Tokushukai Dementia Research Group, Satoru Takahashi, Kenji Ohyama, Masaki Nakato, Masataka Fukue, Yasushi Terada, Shuichi Oshima, Makoto Izuta, Yoshihiro Omori, Junya Kawada, Yasutaka Kurokawa, Yoshitoshi Kida, Shinya Iida, Masao Motomochi, Isao Kitahara, Motoki Sano, Tsunekazu Takagi, and Shuji Noguchi for recruitment of patients and the management, to Mirai Iryo Research Center Inc, Tokyo, Japan for study conduct, data collection, and data management, and to Aurolink, Tokyo, Japan for data analysis. The sponsor jointly participated in the study design with the authors.
Disclosure
H.K. was a member of the board of Eisai Co., Ltd during this study. M.N., and S.N. are employees of Eisai Co., Ltd. K.M. was an employee of Eisai Co., Ltd during this study. The authors report no other conflicts of interest in this work.