A 24-week, multicentre, open evaluation of the clinical effectiveness of the rivastigmine patch in patients with probable Alzheimer's disease

Int J Clin Pract. 2011 Jul;65(7):790-6. doi: 10.1111/j.1742-1241.2011.02713.x. Epub 2011 Jun 6.

Abstract

Background: Cholinesterase inhibitors form the mainstay of treatment for persons with mild-to-moderate Alzheimer's disease (AD). The rivastigmine patch may increase compliance and the proportion of patients maintaining an efficacious dose compared with oral cholinesterase inhibitors.

Objective: To investigate the proportion of patients who reached and maintained the target rivastigmine patch dose compared with the target rivastigmine capsule dose reported in clinical trials.

Methods: This was a multicentre, 24-week, open-label study in persons with probable AD and a Mini-Mental State Examination (MMSE) score of ≥ 10 and ≤ 26. The primary outcome was the proportion of patients (ITT population) treated with 9.5 mg/24 h rivastigmine patch for at least 8 weeks at week 24. Secondary outcomes included week 24 MMSE, Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC), Trail Making Test Part A (TMT-A) and Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scores.

Results: Overall, 208 participants received treatment and 155 (74.5%) completed the study. Within the ITT population, 147/182 patients (80.8%; 95% CI 75.0-86.5%) were treated for at least 8 weeks with the 9.5 mg/24 h rivastigmine patch; 135/182 patients (74.2%; 95% CI 67.8-80.5%) were treated for at least 8 weeks and completed the study. The most common adverse events were nausea (10.1% of patients), erythema (8.7%), pruritus (8.2%) and vomiting (7.2%). At week 24, patients treated with the rivastigmine patch showed improvements on MMSE, ADCS-ADL, ADCS-CGIC and TMT-A scores. Caregivers reported acceptance, preference and satisfaction with the patch.

Conclusion: Transdermal delivery may allow more patients to reach and maintain therapeutic doses of rivastigmine compared with oral rivastigmine.

Trial registration: ClinicalTrials.gov NCT00561392.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Activities of Daily Living
  • Aged
  • Aged, 80 and over
  • Alzheimer Disease / drug therapy*
  • Cholinesterase Inhibitors / administration & dosage*
  • Cholinesterase Inhibitors / adverse effects
  • Cognition / drug effects
  • Female
  • Humans
  • Male
  • Medication Adherence
  • Neuroprotective Agents / administration & dosage*
  • Neuroprotective Agents / adverse effects
  • Phenylcarbamates / administration & dosage*
  • Phenylcarbamates / adverse effects
  • Rivastigmine
  • Transdermal Patch*
  • Treatment Outcome

Substances

  • Cholinesterase Inhibitors
  • Neuroprotective Agents
  • Phenylcarbamates
  • Rivastigmine

Associated data

  • ClinicalTrials.gov/NCT00561392