Study for the Tolerability of Exelon Patch (Rivastigmine) for Alzheimer's Disease (AD) Patients
NCT ID: NCT01312363
Last Updated: 2016-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
300 participants
OBSERVATIONAL
2009-06-30
2011-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease
NCT01399125
Exelon Patch and Combination With Memantine Comparative Trial
NCT01025466
Cognitive Changes in Alzheimer's Disease Patients Associated With or Without White Matter Changes After Rivastigmine
NCT01380288
Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.
NCT00731224
Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease
NCT00423085
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rivastigmine patch
Rivastigmine patch (5-10cm2, daily, 24hr)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
51 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Bundang Hospital
OTHER
Seoul St. Mary's Hospital
OTHER
Korea University
OTHER
Bobath Memorial Hospital
OTHER
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
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 Sanbon Medical Center
UNKNOWN
Yong-in Hyoja Geriatric Hospital
UNKNOWN
Jeju National University
OTHER
Dong-A University Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
SangYun Kim
Department of Neurology, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
SangYun Kim, MD, PhD
Role: STUDY_CHAIR
Seoul National University College of Medicine & Seoul National University Bundang Hospital
Dong Won Yang, MD, PhD
Role: STUDY_DIRECTOR
The Catholic University of Korea
Moon Ho Park, MD, PhD
Role: STUDY_DIRECTOR
Korea University College of Medicine & Korea University Ansan Hospital
Hae Ri Na, MD
Role: STUDY_DIRECTOR
Bobath Memorial Hospital
Young-Chul Yoon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Chungang University College of Medicine & Chungang University Hospital
Seong-Ho Koh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hanyang University College of Medicine & Hanyang University Guri Hospital
Hyun Jeong Han, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kwandong University College of Medicine & Myongji Hospital
Bon D. Ku, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kwandong University College of Medicine & Myongji Hospital
Seong-Hye Choi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Inha University College of Medicine & Inha University Hospital
Jung Seok Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Jeju National University College of Medicine & Jeju National University Hospital
Jun-Seong Lim, MD
Role: PRINCIPAL_INVESTIGATOR
SungAe General Hospital
Jung Eun Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Ewha Womans University School of Medicine & Ewha Womans University Mokdong Hospital
Jeong Yeon Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Inje University College of Medicine & Sanggye Paik Hospital
Hee-Jin Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Hanyang University College of Medicine & Hanyang University Seoul Hospital
Seung Hyun Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hanyang University College of Medicine & Hanyang University Seoul Hospital
Key Hung Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyung Hee University College of Medicine & Kyung Hee University Medical Center
Kyung Won Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dong-A University College of Medicine & Dong-A University Medical Center
Hui Chul Choi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hallym University College of Medicine & Hallym University Chunchon Hospital
Eun-Joo Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Pusan National University School of Medicine & Pusan National University Hospital
Bora Yoon, MD
Role: PRINCIPAL_INVESTIGATOR
Konyang University School of Medicine & Konyang University Hospital
Hyun Duk Yang, MD
Role: PRINCIPAL_INVESTIGATOR
Wonkwang University College of Medicine & Wonkwang University Sanbon Medical Center
Youngsoon Yang, MD
Role: PRINCIPAL_INVESTIGATOR
Yong-in Hyoja Geriatric Hospital
Hee-Jung Seo, MD
Role: PRINCIPAL_INVESTIGATOR
Yong-in Hyoja Geriatric Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dong-A University Hospital
Busan, Busan, South Korea
Pusan National University Hospital
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, South Korea
Myongji Hospital
Goyang-si, Gyeonggi-do, South Korea
Wonkwang University Sanbon Medical Center
Gunpo, Gyeonggi-do, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Bobath Memorial Hospital
Seongnam-si, Gyeonggi-do, South Korea
Yong-in Hyoja Geriatric Hospital
Yongin-si, Gyeonggi-do, South Korea
Inha University Hospital
Incheon, Incheon, South Korea
Jeju National University Hospital
Jeju City, Jeju-do, South Korea
Seoul St. Mary's Hospital
Seoul, Seoul, South Korea
SungAe General Hospital
Seoul, Seoul, South Korea
Chungang University Hospital
Seoul, Seoul, 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
X-MEN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.