Study for the Tolerability of Exelon Patch (Rivastigmine) for Alzheimer's Disease (AD) Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      The investigators plan to see what factors can influence the durability of Exelon patch
      treatment in Korean patients with Alzheimer's disease.

      Based on these results, the investigators will find the ways to maximize the effect and
      durability of Exelon patch on Korean patients with Alzheimer's disease.

      After finishing this study, the investigators are going to present the study results at the
      international and national academic meetings or conferences.

      Also the investigators expect that they can publish the result in a journal of in the field
      of neurology or dementia till the winter of 2010.
    

Detailed description: 
      A once-daily Exelon patch has recently been developed to reduce the GI side effect of
      rivastigmine and make application easier by once a day.

      Thinking the patch as the first-line drug, it should be proven as safe for a long time. The
      safety and clinical effect of Exelon patch was tested in many studies.

      However, most of studies have been conducted on Western countries and the study period was
      not more than a year.

      There are only few data on Exelon patch related to other ethnic such as Asian patients with
      Alzheimer's disease.

      Especially, there are many different environmental factors between Western and Asia
      countries, such as habitual or climate factors, skin type and behavioral styles which may be
      influenced on patch durability.

      The aim of this study was to evaluate the durability of Exelon patch in Korean patients with
      Alzheimer's disease and what are the factors influencing the durability.

      Also evaluating the significance of factors gives us the way to increase the patch
      durability.

      Thirty patients per investigational center will be enrolled during 6 months.

      Probable mild to moderate AD patients will be included whether they have depression or other
      neurological symptoms or diseases.

      The period of this study will be 6 months, and we will start the treatment starting from
      Exelon patch 5cm2.

      After 4 weeks, dose titration will be attempted to Exelon patch 10cm2.

      If a patient is reporting too much discomfort to stick on high dose patch, investigators will
      assess the severity of the side effects followed by adjusting dose or considering
      discontinuation.

      Cognitive, functional, and global outcome measures are obtained at baseline and at the end of
      month 6. Environmental factors including caregiver condition, participant's habitat type, and
      participant's skin type, etc. are also evaluated from the first visit, and they will be
      assessed at every visit.

      Participants and their caregivers will be asked of any possible concerns or problems
      associated with patch use at every visit. And if there is any visible problem or adverse
      event, it will be taken as a picture and be uploaded to investigation web site for this
      study.

      Finally, for the primary endpoint, participants who discontinue prematurely are evaluated
      during every visit.

      Signs of skin irritation at the site of patch application are assessed at every visit by the
      investigator using skin irritation rating scale.

      Caregivers evaluate patch adhesion throughout the study with ratings provided in accordance
      with a patch adhesion scoring system.

      To assess factors to influence skin irritation or any other adverse events, we will classify
      skin type of each participant using "skin type measuring paper" at the first visit time.

      We will search for any personal or family history of allergy, and characteristics of
      participant's habitat using questionnaire.

      The information about the caregiver including his/her condition based on the annual income,
      living status, and education level.

      To see if there is any specific allergic factor for discontinuation, we will investigate
      participant's allergy history more completely and thoroughly.
    

Intervention name(s): Rivastigmine patch
Intervention type(s): Drug
Intervention description(s): Rivastigmine patch (5-10cm2, daily, 24hr)
Other intervention name(s): Exelon patch
Intervention MeSH terms: Rivastigmine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Alzheimer's disease
      
Keywords: Alzheimer's disease; Rivastigmine; Patch; Tolerability