title: A 24-week, multicentre, open evaluation of the clinical effectiveness of the rivastigmine patch in patients with probable Alzheimer's disease.
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.
  
  
  CONCLUSIONS
  Transdermal delivery may allow more patients to reach and maintain therapeutic doses of rivastigmine compared with oral rivastigmine.
authors.affiliation: Novartis Pharma GmbH, Nuremberg, Germany. konstantin.articus@novartis.com
authors.forename: K
authors.initials: K
authors.lastname: Articus
authors.forename: M
authors.initials: M
authors.lastname: Baier
authors.forename: F
authors.initials: F
authors.lastname: Tracik
authors.forename: F
authors.initials: F
authors.lastname: Kühn
authors.forename: U W
authors.initials: UW
authors.lastname: Preuss
authors.forename: A
authors.initials: A
authors.lastname: Kurz
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy*; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D003071:Cognition / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D018696:Neuroprotective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D048448:Phenylcarbamates / Q000008:administration & dosage* / Q000009:adverse effects; D000068836:Rivastigmine; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D002800:Cholinesterase Inhibitors; D018696:Neuroprotective Agents; D048448:Phenylcarbamates; D000068836:Rivastigmine