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

Alzheimer's Disease Clinical Trial

— X-MEN  

Official title:

A Six-month, Open Labeled, Multi-centered, Observational Study for the Tolerability of Exelon Patch (Rivastigmine) for Patients With Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312363
• Other study ID #: X-MEN
• Status: Completed
• Phase: N/A
• First received: October 26, 2010
• Last updated: May 2, 2016
• Start date: June 2009
• Est. completion date: July 2011

Study information

• Verified date: May 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan	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	Myongji Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Wonkwang University Sanbon Medical Center	Gunpo-si	Gyeonggi-do
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Gyeonggi-do
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Jeju National University Hospital	Jeju
Korea, Republic of	Bobath Memorial Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Chungang University Hospital	Seoul
Korea, Republic of	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	Sanggye Paik Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	SungAe General Hospital	Seoul
Korea, Republic of	Yong-in Hyoja Geriatric Hospital	Yongin-si	Gyeonggi-do

Sponsors (21)

Lead Sponsor

Collaborator

Seoul National University Hospital

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events	number of participants with skin irritation or other adverse events	24 weeks	No
Secondary	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.	24 weeks	No