A 48-Week, Multicenter, Open-Label, Observational Study Evaluating Oral Rivastigmine in Patients with Mild-to-Moderate Alzheimer’s Disease in Taiwan

  • Chiung-Chih Chang
  • Giia-Sheun Peng
  • Te-Jen Lai
  • Chien-Hsun Li
  • Ching-Kuan LiuEmail author
Original Research



Rivastigmine is a cholinesterase inhibitor, approved for the treatment of mild-to-moderate dementia of Alzheimer’s type. This study assessed the short- and long-term effectiveness and safety of rivastigmine in patients with mild-to-moderate Alzheimer’s disease (AD) in a real-world clinical setting in Taiwan.


This was a 48-week, single-arm, open-label, prospective, observational, post-marketing surveillance, multicenter study. The primary outcomes were change from baseline to week 48 in the Mini-Mental State Examination (MMSE) and Clinical Dementia Rating (CDR) scores. One-year persistence to treatment, effect on activities of daily living, and incidence of adverse events (AEs) were also assessed.


Overall, 151 patients were enrolled in the study, of which 91 (60.26%) completed this study. At the end of the study, the mean rivastigmine dose received by the patients was 6.59 mg/day. At week 48, the changes in mean [standard deviation (SD)] MMSE and CDR scores in the intent-to-treat (ITT) population from baseline were − 1.00 (3.8; p = 0.0344) and 0.07 (0.29; p = 0.0403), respectively. The most frequently reported AEs by preferred term were dizziness (12.58%) and nausea (9.27%). No new or unexpected AEs were observed, and 30 (20.13%) patients in the ITT population were on rivastigmine therapy for 1 year without treatment discontinuation.


Despite the low 1-year persistence rate, rivastigmine showed a stabilizing effect on declining cognition in patients with mild-to-moderate AD in a real-world scenario. Rivastigmine is well tolerated at 6.0–9.0 mg/day with no unexpected safety concerns.


Novartis Co. Ltd., Taipei, Taiwan.


Alzheimer’s disease Cognition Dementia Neurology Rivastigmine Treatment persistence 



We thank the participants of the study.


This study was funded by Novartis Co. Ltd., Taipei, Taiwan. The article processing fee was funded by Novartis Co. Ltd., Taipei, Taiwan. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

Medical Writing Assistance

The authors thank Dinesh T. Makhija, Novartis Healthcare Pvt. Ltd, Hyderabad, India, for providing medical writing assistance.


All authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published.


Chiung-Chih Chang, Giia-Sheun Peng, Te-Jen Lai, Chien-Hsun Li, and Ching-Kuan Liu have nothing to disclose.

Compliance with Ethics Guidelines

The study was conducted in accordance with the ethical principles of the Declaration of Helsinki and was approved by the following institutional review boards: the institutional review board of Tri-Service General Hospital, Chang Gung Medical Foundation Institutional Review Board, the Institutional Review Board of the Kaohsiung Medical University Hospital, and the Institutional Review Board of Chung Shan Medical University Hospital. All patients provided written informed consent before enrollment.

Data Availability

The data sets during and/or analyzed during the current study are available from the corresponding author on reasonable request.


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Copyright information

© Springer Healthcare Ltd., part of Springer Nature 2019

Authors and Affiliations

  • Chiung-Chih Chang
    • 1
  • Giia-Sheun Peng
    • 2
  • Te-Jen Lai
    • 3
  • Chien-Hsun Li
    • 4
  • Ching-Kuan Liu
    • 4
    • 5
    • 6
    Email author
  1. 1.Department of Neurology, Cognition and Aging Center, Kaohsiung Chang Gung Memorial HospitalChang Gung University College of MedicineKao-hsiungTaiwan
  2. 2.Taipei Veterans General Hospital Hsinchu BranchHsinchu CountyTaiwan
  3. 3.Institute of Medicine and Department of PsychiatryChung Shan Medical University HospitalTaichungTaiwan
  4. 4.Department of NeurologyKaohsiung Medical University HospitalKaohsiungTaiwan
  5. 5.Department of NeurologySchool of Medicine, Kaohsiung Medical UniversityKaohsiungTaiwan
  6. 6.Graduate Institute of MedicineCollege of Medicine, Kaohsiung Medical UniversityKaohsiungTaiwan

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