Alzheimer's DiseaseX-MENNCT01312363
Study for the Tolerability of Exelon Patch (Rivastigmine) for Alzheimer's Disease (AD) Patients
An observational study of Alzheimer's Disease, run by Seoul National University Hospital at 19 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 51 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Rivastigmine patch
- How many people
- 300 participants
- Where
- 19 sitesSouth Korea
- Study dates
- Jun 2009to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Alzheimer's disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
South Korea19 sites
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 425-707
Dong-A University Hospital
Busan, Busan
Pusan National University Hospital
Busan, Busan
Hallym University Chunchon Hospital
Chunchon, Chunchon
Konyang University Hospital
Daejeon, Daejeon
Myongji Hospital
Goyang-si, Gyeonggi-do, 412-270
Wonkwang University Sanbon Medical Center
Gunpo, Gyeonggi-do, 435-040
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 471-701
Inha University Hospital
Incheon, Incheon, 400-711
Jeju National University Hospital
Jeju City, Jeju-do, 690-756
Bobath Memorial Hospital
Seongnam-si, Gyeonggi-do, 463-480
Seoul St. Mary's Hospital
Seoul, Seoul, 137-701
SungAe General Hospital
Seoul, Seoul, 150-051
Chungang University Hospital
Seoul, Seoul, 156-755
Ewha Womans University Hospital
Seoul, Seoul
Hanyang University Seoul Hospital
Seoul, Seoul
Kyung Hee University Medical Center
Seoul, Seoul
Sanggye Paik Hospital
Seoul, Seoul
Yong-in Hyoja Geriatric Hospital
Yongin-si, Gyeonggi-do
About this study
Official title: A Six-month, Open Labeled, Multi-centered, Observational Study for the Tolerability of Exelon Patch (Rivastigmine) for Patients With Alzheimer's Disease
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.
Read the detailed description
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.
- Conditions
- Alzheimer's Disease
- Being tested
- Rivastigmine patch
- Keywords
- Alzheimer's disease, Rivastigmine, Patch, Tolerability
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivastigmine patchDrug
Also called Exelon patch
Rivastigmine patch (5-10cm2, daily, 24hr)
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
number of participants with skin irritation or other adverse events
Measured: 24 weeks
Secondary outcomes (1)
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Korea University, Bobath Memorial Hospital, hung-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, Yong-in Hyoja Geriatric Hospital, Jeju National University, Dong-A University Hospital
- Responsible party
- Principal investigator, SangYun Kim, Seoul National University Hospital
- Investigators
- SangYun Kim, MD, PhD, Study chair, Seoul National University College of Medicine & Seoul National University Bundang HospitalDong Won Yang, MD, PhD, Study director, The Catholic University of KoreaMoon Ho Park, MD, PhD, Study director, Korea University College of Medicine & Korea University Ansan HospitalHae Ri Na, MD, Study director, Bobath Memorial HospitalYoung-Chul Yoon, MD, PhD, Principal investigator, Chungang University College of Medicine & Chungang University HospitalSeong-Ho Koh, MD, PhD, Principal investigator, Hanyang University College of Medicine & Hanyang University Guri HospitalHyun Jeong Han, MD, PhD, Principal investigator, Kwandong University College of Medicine & Myongji HospitalBon D. Ku, MD, PhD, Principal investigator, Kwandong University College of Medicine & Myongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312363
- Sponsor's protocol ID
- X-MEN
- Acronym
- X-MEN
- Status last verified
- May 2016
- First submitted
- 26 Oct 2010
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-month, Open Labeled, Multi-centered, Observational Study for the Tolerability of Exelon Patch (Rivastigmine) for Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01312363
- Acronym / sponsor ID
- X-MEN / X-MEN
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, Rivastigmine, Patch, Tolerability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Korea University, Bobath Memorial Hospital, hung-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, Yong-in Hyoja Geriatric Hospital, Jeju National University, Dong-A University Hospital
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 51 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Alzheimer's disease
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivastigmine patchAlso: Exelon patchRivastigmine patch (5-10cm2, daily, 24hr) | Drug | – |
Primary outcome
Number of participants with adverse events
Time frame: 24 weeks
number of participants with skin irritation or other adverse events
1 secondary outcome
Factors for the disuse of Rivastigmine patch
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SangYun Kim, MD, PhD study chair
Seoul National University College of Medicine & Seoul National University Bundang Hospital
Dong Won Yang, MD, PhD study director
The Catholic University of Korea
Moon Ho Park, MD, PhD study director
Korea University College of Medicine & Korea University Ansan Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Seoul National University Hospital at 19 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016; AzTrials last refreshed its copy on 7 Nov 2026.