Clinical trial NCT01312363: Study for the Tolerability of Exelon Patch (Rivastigmine) for Alzheimer's Disease (AD) Patients
Official title: A Six-month, Open Labeled, Multi-centered, Observational Study for the Tolerability of Exelon Patch (Rivastigmine) for Patients With Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Rivastigmine
Patch
Tolerability
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Seoul St. Mary's Hospital
name: Korea University
name: Bobath Memorial Hospital
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Hanyang University
name: Kwandong University Myongji Hospital
name: Inha University Hospital
name: SungAe General Hospital
name: Ewha Womans University
name: Inje University
name: Hanyang University Seoul Hospital
name: Kyunghee University Medical Center
name: Hallym University Medical Center
name: Pusan National University Hospital
name: Konyang University Hospital
name: Wonkwang University Sanbon Medical Center
name: Yong-in Hyoja Geriatric Hospital
name: Jeju National University
name: Dong-A University Hospital
First posted: 2011-03-10
Enrollment: 300
Sex: ALL
Minimum age (years): 51
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Alzheimer's disease

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 24 weeks
Secondary outcomes:
measure: Factors for the disuse of Rivastigmine patch
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi-do
city: Gunpo-si
country: Korea, Republic of
facility: Wonkwang University Sanbon Medical Center
state: Gyeonggi-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Bobath Memorial Hospital
state: Gyeonggi-do
city: Yongin-si
country: Korea, Republic of
facility: Yong-in Hyoja Geriatric Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Chunchon
country: Korea, Republic of
facility: Hallym University Chunchon Hospital
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: SungAe General Hospital
city: Seoul
country: Korea, Republic of
facility: Chungang University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Sanggye Paik Hospital
Study officials:
affiliation: Seoul National University College of Medicine & Seoul National University Bundang Hospital
name: SangYun Kim, MD, PhD
role: STUDY_CHAIR
affiliation: The Catholic University of Korea
name: Dong Won Yang, MD, PhD
role: STUDY_DIRECTOR
affiliation: Korea University College of Medicine & Korea University Ansan Hospital
name: Moon Ho Park, MD, PhD
role: STUDY_DIRECTOR
affiliation: Bobath Memorial Hospital
name: Hae Ri Na, MD
role: STUDY_DIRECTOR
affiliation: Chungang University College of Medicine & Chungang University Hospital
name: Young-Chul Yoon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University College of Medicine & Hanyang University Guri Hospital
name: Seong-Ho Koh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kwandong University College of Medicine & Myongji Hospital
name: Hyun Jeong Han, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kwandong University College of Medicine & Myongji Hospital
name: Bon D. Ku, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University College of Medicine & Inha University Hospital
name: Seong-Hye Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jeju National University College of Medicine & Jeju National University Hospital
name: Jung Seok Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SungAe General Hospital
name: Jun-Seong Lim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans University School of Medicine & Ewha Womans University Mokdong Hospital
name: Jung Eun Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University College of Medicine & Sanggye Paik Hospital
name: Jeong Yeon Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University College of Medicine & Hanyang University Seoul Hospital
name: Hee-Jin Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University College of Medicine & Hanyang University Seoul Hospital
name: Seung Hyun Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyung Hee University College of Medicine & Kyung Hee University Medical Center
name: Key Hung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dong-A University College of Medicine & Dong-A University Medical Center
name: Kyung Won Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University College of Medicine & Hallym University Chunchon Hospital
name: Hui Chul Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University School of Medicine & Pusan National University Hospital
name: Eun-Joo Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Konyang University School of Medicine & Konyang University Hospital
name: Bora Yoon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang University College of Medicine & Wonkwang University Sanbon Medical Center
name: Hyun Duk Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yong-in Hyoja Geriatric Hospital
name: Youngsoon Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yong-in Hyoja Geriatric Hospital
name: Hee-Jung Seo, MD
role: PRINCIPAL_INVESTIGATOR
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