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

NCT01312363 | Completed DMC

• 1 other identifier: X-MEN
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; Rivastigmine; Patch; Tolerability

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  number of participants with skin irritation or other adverse events

  24 weeks

Secondary Outcomes (1)

• Factors for the disuse of Rivastigmine patch

  24 weeks

Interventions

Rivastigmine patch DRUG

Rivastigmine patch (5-10cm2, daily, 24hr)

Also known as: Exelon patch

Eligibility Criteria

• Age: 51 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Alzheimer's disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• Seoul St. Mary's Hospital: collaborator
• Korea University: collaborator
• Bobath Memorial Hospital: collaborator
• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: collaborator
• Hanyang University: collaborator
• Kwandong University Myongji Hospital: collaborator
• Inha University Hospital: collaborator
• SungAe General Hospital: collaborator
• Ewha Womans University: collaborator
• Inje University: collaborator
• Hanyang University Seoul Hospital: collaborator
• Kyunghee University Medical Center: collaborator
• Hallym University Medical Center: collaborator
• Pusan National University Hospital: collaborator
• Konyang University Hospital: collaborator
• Wonkwang University Sanbon Medical Center: collaborator
• Yong-in Hyoja Geriatric Hospital: collaborator
• Jeju National University: collaborator
• Dong-A University Hospital: collaborator

Study Sites (19)

Dong-A University Hospital

Busan, Busan, South Korea

Location

Pusan National University Hospital

Busan, Busan, South Korea

Location

Hallym University Chunchon Hospital

Chunchon, Chunchon, South Korea

Location

Konyang University Hospital

Daejeon, Daejeon, South Korea

Location

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 425-707, South Korea

Location

Myongji Hospital

Goyang-si, Gyeonggi-do, 412-270, South Korea

Location

Wonkwang University Sanbon Medical Center

Gunpo, Gyeonggi-do, 435-040, South Korea

Location

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, 471-701, South Korea

Location

Bobath Memorial Hospital

Seongnam-si, Gyeonggi-do, 463-480, South Korea

Location

Yong-in Hyoja Geriatric Hospital

Yongin-si, Gyeonggi-do, South Korea

Location

Inha University Hospital

Incheon, Incheon, 400-711, South Korea

Location

Jeju National University Hospital

Jeju City, Jeju-do, 690-756, South Korea

Location

Seoul St. Mary's Hospital

Seoul, Seoul, 137-701, South Korea

Location

SungAe General Hospital

Seoul, Seoul, 150-051, South Korea

Location

Chungang University Hospital

Seoul, Seoul, 156-755, South Korea

Location

Ewha Womans University Hospital

Seoul, Seoul, South Korea

Location

Hanyang University Seoul Hospital

Seoul, Seoul, South Korea

Location

Kyung Hee University Medical Center

Seoul, Seoul, South Korea

Location

Sanggye Paik Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neurology, Seoul National University College of Medicine, Seoul National University Bundang Hospital

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: March 10, 2011
• Study Start: June 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 4, 2016

Record last verified: 2016-05

Locations

KR (19)