Study for the Tolerability of Exelon Patch (Rivastigmine) for Alzheimer's Disease (AD) Patients (X-MEN)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Seoul National University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Seoul National University Hospital
Collaborators:
Seoul National University Bundang Hospital
Seoul St. Mary's Hospital
Korea University
Bobath Memorial Hospital
Chungang University Hospital
Hanyang University
Kwandong University Myongji Hospital
Inha University Hospital
SungAe General Hospital
Ewha Womans University
Inje University
Hanyang University Seoul Hospital
Kyunghee University Medical Center
Hallym University Medical Center
Pusan National University Hospital
Konyang University Hospital
Wonkwang University Sanbon Medical Center
Yong-in Hyoja Geriatric Hospital
Jeju National University
Dong-A University Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01312363
First received: October 26, 2010
Last updated: March 8, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Alzheimer's Disease |
Drug: Rivastigmine patch |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Six-month, Open Labeled, Multi-centered, Observational Study for the Tolerability of Exelon Patch (Rivastigmine) for Patients With Alzheimer's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- Number of participants with adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]number of participants with skin irritation or other adverse events
Secondary Outcome Measures:
- Factors for the disuse of Rivastigmine patch [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 300 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Rivastigmine patch
Rivastigmine patch (5-10cm2, daily, 24hr)
Other Name: Exelon patch
Show Detailed Description Eligibility| Ages Eligible for Study: | 51 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with Alzheimer's disease
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312363
Contacts
| Contact: SangYun Kim, MD, PhD | 82-31-787-7462 | parkmuno@yahoo.co.kr |
| Contact: SangYun Kim, MD, PhD | 82-31-787-7462 | neuroksy@snu.ac.kr |
Locations
| Korea, Republic of | |
| Korea University Ansan Hospital | Recruiting |
| Ansan, Gyeonggi-do, Korea, Republic of, 425-707 | |
| Contact: Moon Ho Park, MD, PhD 82-31-412-5150 | |
| Principal Investigator: Moon Ho Park, MD, PhD | |
| Myongji Hospital | Recruiting |
| Goyang-si, Gyeonggi-do, Korea, Republic of, 412-270 | |
| Contact: Bon D. Ku, MD, PhD | |
| Principal Investigator: Hyun Jeong Han, MD, PhD | |
| Principal Investigator: Bon D. Ku, MD, PhD | |
| Wonkwang University Sanbon Medical Center | Recruiting |
| Gunpo-si, Gyeonggi-do, Korea, Republic of, 435-040 | |
| Contact: Hyun Duk Yang, MD | |
| Principal Investigator: Hyun Duk Yang, MD | |
| Hanyang University Guri Hospital | Recruiting |
| Guri-si, Gyeonggi-do, Korea, Republic of, 471-701 | |
| Contact: Seong-Ho Koh, MD, PhD | |
| Principal Investigator: Seong-Ho koh, MD, PhD | |
| Bobath Memorial Hospital | Recruiting |
| Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-480 | |
| Contact: Hae Ri Na, MD | |
| Principal Investigator: Hae Ri Na, MD | |
| Yong-in Hyoja Geriatric Hospital | Recruiting |
| Yongin-si, Gyeonggi-do, Korea, Republic of | |
| Contact: Youngsoon Yang, MD | |
| Principal Investigator: Youngsoon Yang, MD | |
| Principal Investigator: Hee-Jung Seo, MD | |
| Pusan National University Hospital | Recruiting |
| Busan, Korea, Republic of | |
| Contact: Eun-Joo Kim, MD | |
| Principal Investigator: Eun-Joo Kim, MD | |
| Dong-A University Hospital | Recruiting |
| Busan, Korea, Republic of | |
| Contact: Kyung Won Park, MD, PhD | |
| Principal Investigator: Kyung Won Park, MD, PhD | |
| Hallym University Chunchon Hospital | Recruiting |
| Chunchon, Korea, Republic of | |
| Contact: Hui Chul Choi, MD, PhD | |
| Principal Investigator: Hui Chul Choi, MD, PhD | |
| Konyang University Hospital | Recruiting |
| Daejeon, Korea, Republic of | |
| Contact: Bora Yoon, MD | |
| Principal Investigator: Bora Yoon, MD | |
| Inha University Hospital | Recruiting |
| Incheon, Korea, Republic of, 400-711 | |
| Contact: Seong-Hye Choi, MD, PhD | |
| Principal Investigator: Seong-Hye Choi, MD, PhD | |
| Jeju National University Hospital | Recruiting |
| Jeju, Korea, Republic of, 690-756 | |
| Contact: Jung Seok Lee, MD | |
| Principal Investigator: Jung Seok Lee, MD | |
| Kyung Hee University Medical Center | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Key Hung Park, MD, PhD | |
| Principal Investigator: Key Hung Park, MD, PhD | |
| Chungang University Hospital | Recruiting |
| Seoul, Korea, Republic of, 156-755 | |
| Contact: Young-Chul Yoon, MD, PhD | |
| Principal Investigator: Young-Chul Yoon, MD, PhD | |
| Seoul St. Mary's Hospital | Recruiting |
| Seoul, Korea, Republic of, 137-701 | |
| Contact: Dong Won Yang, MD, PhD 82-16-354-7368 neuroman@catholic.ac.kr | |
| Principal Investigator: Dong Won Yang, MD, PhD | |
| Ewha Womans University Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Jung Eun Kim, MD | |
| Principal Investigator: Jung Eun Kim, MD | |
| Sanggye Paik Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Jeong Yeon Kim, MD | |
| Principal Investigator: Jeong Yeon Kim, MD | |
| Hanyang University Seoul Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Hee-Jin Kim, MD | |
| Principal Investigator: Hee-Jin Kim, MD | |
| Principal Investigator: Seung Hyun Kim, MD, PhD | |
| SungAe General Hospital | Recruiting |
| Seoul, Korea, Republic of, 150-051 | |
| Contact: Jun-Seong Lim, MD | |
| Principal Investigator: Jun-Seong Lim, MD | |
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Seoul St. Mary's Hospital
Korea University
Bobath Memorial Hospital
Chungang University Hospital
Hanyang University
Kwandong University Myongji Hospital
Inha University Hospital
SungAe General Hospital
Ewha Womans University
Inje University
Hanyang University Seoul Hospital
Kyunghee University Medical Center
Hallym University Medical Center
Pusan National University Hospital
Konyang University Hospital
Wonkwang University Sanbon Medical Center
Yong-in Hyoja Geriatric Hospital
Jeju National University
Dong-A University Hospital
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 Seoul St.Mary's Hospital |
| 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 |
More Information
No publications provided
| Responsible Party: | SangYun Kim, MD, PhD, Department of Neurology, Seoul National University Bundang Hospital |
| ClinicalTrials.gov Identifier: | NCT01312363 History of Changes |
| Other Study ID Numbers: | X-MEN |
| Study First Received: | October 26, 2010 |
| Last Updated: | March 8, 2011 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Seoul National University Hospital:
|
Alzheimer's disease Rivastigmine Patch Tolerability |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Rivastigmine Cholinesterase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuroprotective Agents Protective Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013