Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| Seoul St. Mary's Hospital | OTHER |
| Korea University | OTHER |
| Bobath Memorial Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine patch | Drug | Rivastigmine patch (5-10cm2, daily, 24hr) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | number of participants with skin irritation or other adverse events | 24 weeks |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with Alzheimer's disease
Not provided
| Name | Affiliation | Role |
|---|---|---|
| SangYun Kim, MD, PhD | Seoul National University College of Medicine & Seoul National University Bundang Hospital | Study Chair |
| 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 | Study Director |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Hospital | Busan | Busan | South Korea | |||
| Pusan National University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| hung-Ang University Hosptial, Chung-Ang University College of Medicine | UNKNOWN |
| Hanyang University | OTHER |
| Kwandong University Myongji Hospital | UNKNOWN |
| Inha University Hospital | OTHER |
| SungAe General Hospital | UNKNOWN |
| Ewha Womans University | OTHER |
| Inje University | OTHER |
| Hanyang University Seoul Hospital | OTHER |
| Kyunghee University Medical Center | OTHER |
| Hallym University Medical Center | OTHER |
| Pusan National University Hospital | OTHER |
| Konyang University Hospital | OTHER |
| Wonkwang University | OTHER |
| Yong-in Hyoja Geriatric Hospital | UNKNOWN |
| Jeju National University | OTHER |
| Dong-A University Hospital | OTHER |
Not provided
Not provided
Not provided
| 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 | Principal Investigator |
| Busan |
| Busan |
| South Korea |
| Hallym University Chunchon Hospital | Chunchon | Chunchon | South Korea |
| Konyang University Hospital | Daejeon | Daejeon | South Korea |
| Korea University Ansan Hospital | Ansan | Gyeonggi-do | 425-707 | South Korea |
| Myongji Hospital | Goyang-si | Gyeonggi-do | 412-270 | South Korea |
| Wonkwang University Sanbon Medical Center | Gunpo | Gyeonggi-do | 435-040 | South Korea |
| Hanyang University Guri Hospital | Guri-si | Gyeonggi-do | 471-701 | South Korea |
| Bobath Memorial Hospital | Seongnam-si | Gyeonggi-do | 463-480 | South Korea |
| Yong-in Hyoja Geriatric Hospital | Yongin-si | Gyeonggi-do | South Korea |
| Inha University Hospital | Incheon | Incheon | 400-711 | South Korea |
| Jeju National University Hospital | Jeju City | Jeju-do | 690-756 | South Korea |
| Seoul St. Mary's Hospital | Seoul | Seoul | 137-701 | South Korea |
| SungAe General Hospital | Seoul | Seoul | 150-051 | South Korea |
| Chungang University Hospital | Seoul | Seoul | 156-755 | South Korea |
| Ewha Womans University Hospital | Seoul | Seoul | South Korea |
| Hanyang University Seoul Hospital | Seoul | Seoul | South Korea |
| Kyung Hee University Medical Center | Seoul | Seoul | South Korea |
| Sanggye Paik Hospital | Seoul | Seoul | South Korea |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided