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

This study has been completed.
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
Seoul St. Mary's Hospital
Korea University
Bobath Memorial Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
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 (Responsible Party):
SangYun Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01312363
First received: October 26, 2010
Last updated: May 2, 2016
Last verified: May 2016
  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:


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.


Enrollment: 300
Study Start Date: June 2009
Study Completion Date: July 2011
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312363

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

Responsible Party: SangYun Kim, Department of Neurology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01312363     History of Changes
Other Study ID Numbers: X-MEN 
Study First Received: October 26, 2010
Last Updated: May 2, 2016
Health Authority: Korea: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

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
Neurocognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 27, 2016