Study for the Tolerability of Exelon Patch (Rivastigmine) for Alzheimer's Disease (AD) Patients (X-MEN)

A Six-month, Open Labeled, Multi-centered, Observational Study for the Tolerability of Exelon Patch (Rivastigmine) for Patients With Alzheimer's Disease

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Rivastigmine patch

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Dong-A University Hospital
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Chunchon, Korea, Republic of
    • Hallym University Chunchon Hospital
  • Daejeon, Korea, Republic of
    • Konyang University Hospital
  • Incheon, Korea, Republic of, 400-711
    • Inha University Hospital
  • Jeju, Korea, Republic of, 690-756
    • Jeju National University Hospital
  • Seoul, Korea, Republic of, 137-701
    • Seoul st. mary's hospital
  • Seoul, Korea, Republic of
    • Kyung Hee University Medical Center
  • Seoul, Korea, Republic of, 156-755
    • Chungang University Hospital
  • Seoul, Korea, Republic of, 150-051
    • SungAe General Hospital
  • Seoul, Korea, Republic of
    • Ewha Womans University Hospital
  • Seoul, Korea, Republic of
    • Hanyang University Seoul Hospital
  • Seoul, Korea, Republic of
    • Sanggye Paik hospital
  • Gyeonggi-do
    • Ansan, Gyeonggi-do, Korea, Republic of, 425-707
      • Korea University Ansan Hospital
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 412-270
      • Myongji Hospital
    • Gunpo-si, Gyeonggi-do, Korea, Republic of, 435-040
      • Wonkwang University Sanbon Medical Center
    • Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
      • Hanyang University GURI Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-480
      • Bobath Memorial Hospital
    • Yongin-si, Gyeonggi-do, Korea, Republic of
      • Yong-in Hyoja Geriatric Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Alzheimer's disease

Description

Inclusion Criteria:

• Probable AD by NINCDS-ADRDA and DSM-IV
• Male and female aged from 51 to 85 years old
• Magnetic resonance imaging or computed tomographic scan within 12 months consistent with a diagnosis of probable AD
• Patients who approved to release of personal information

Exclusion Criteria:

• Patient with any active pulmonary, gastrointestinal, renal, hepatic (severe hepatic function impaired patients), endocrine, or cardiovascular disease, clinically significant laboratory abnormalities, or any medical condition which would prohibit them from completing the study
• Any patients suspicious of drug addiction or alcohol addiction for the past 10 years
• Any other patients to be decided to be inappropriate for the study by the investigators

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	number of participants with skin irritation or other adverse events	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors for the disuse of Rivastigmine patch	to search for the factors that affect the disuse of Rivastigmine patch in each patient, such as skin irritation,abnormal clinical laboratory factors, or environmental factors.	24 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul St. Mary's Hospital; Pusan National University Hospital; Seoul National University Bundang Hospital; Korea University; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Inje University; Hanyang University; Ewha Womans University; Dong-A University Hospital; Hanyang University Seoul Hospital; Hallym University Medical Center; Kyunghee University Medical Center; Inha University Hospital; Konyang University Hospital; Bobath Memorial Hospital; Kwandong University Myongji Hospital; SungAe General Hospital; Wonkwang University Sanbon Medical Center; Yong-in Hyoja Geriatric Hospital; Jeju National University
• Investigators: Study Chair: SangYun Kim, MD, PhD, Seoul National University College of Medicine & Seoul National University Bundang Hospital; Study Director: Dong Won Yang, MD, PhD, The Catholic University of Korea; Study Director: Moon Ho Park, MD, PhD, Korea University College of Medicine & Korea University Ansan Hospital; Study Director: Hae Ri Na, MD, Bobath Memorial Hospital; Principal Investigator: Young-Chul Yoon, MD, PhD, Chungang University College of Medicine & Chungang University Hospital; Principal Investigator: Seong-Ho Koh, MD, PhD, Hanyang University College of Medicine & Hanyang University Guri Hospital; Principal Investigator: Hyun Jeong Han, MD, PhD, Kwandong University College of Medicine & Myongji Hospital; Principal Investigator: Bon D. Ku, MD, PhD, Kwandong University College of Medicine & Myongji Hospital; Principal Investigator: Seong-Hye Choi, MD, PhD, Inha University College of Medicine & Inha University Hospital; Principal Investigator: Jung Seok Lee, MD, Jeju National University College of Medicine & Jeju National University Hospital; Principal Investigator: Jun-Seong Lim, MD, SungAe General Hospital; Principal Investigator: Jung Eun Kim, MD, Ewha Womans University School of Medicine & Ewha Womans University Mokdong Hospital; Principal Investigator: Jeong Yeon Kim, MD, Inje University College of Medicine & Sanggye Paik Hospital; Principal Investigator: Hee-Jin Kim, MD, Hanyang University College of Medicine & Hanyang University Seoul Hospital; Principal Investigator: Seung Hyun Kim, MD, PhD, Hanyang University College of Medicine & Hanyang University Seoul Hospital; Principal Investigator: Key Hung Park, MD, PhD, Kyung Hee University College of Medicine & Kyung Hee University Medical Center; Principal Investigator: Kyung Won Park, MD, PhD, Dong-A University College of Medicine & Dong-A University Medical Center; Principal Investigator: Hui Chul Choi, MD, PhD, Hallym University College of Medicine & Hallym University Chunchon Hospital; Principal Investigator: Eun-Joo Kim, MD, Pusan National University School of Medicine & Pusan National University Hospital; Principal Investigator: Bora Yoon, MD, Konyang University School of Medicine & Konyang University Hospital; Principal Investigator: Hyun Duk Yang, MD, Wonkwang University College of Medicine & Wonkwang University Sanbon Medical Center; Principal Investigator: Youngsoon Yang, MD, Yong-in Hyoja Geriatric Hospital; Principal Investigator: Hee-Jung Seo, MD, Yong-in Hyoja Geriatric Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: October 26, 2010
• First Submitted That Met QC Criteria: March 8, 2011
• First Posted (Estimate): March 10, 2011

Study Record Updates

• Last Update Posted (Estimate): May 4, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Rivastigmine; Tolerability; Patch
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Cholinesterase Inhibitors; Rivastigmine
• Other Study ID Numbers: X-Men

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided