Cognitive Changes in Alzheimer's Disease Patients Associated With or Without White Matter Changes After Rivastigmine
CAREER
Changes of Cognitive Function in Patients With Mild to Moderate Alzheimer's Disease Associated With or Without White Matter Changes After Rivastigmine Patch Therapy - Multi-center, Prospective, Open-label Clinical Trial
1 other identifier
interventional
300
1 country
16
Brief Summary
The purpose of this study is to evaluate and compare the changes of cognitive function (as measured by ADAS-Cog) in the two group of patients with Alzheimer's disease (AD) associated with and without white matter changes after rivastigmine patch therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 21, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedFebruary 5, 2018
February 1, 2018
5.5 years
June 21, 2011
February 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The changes of cognitive function as measured by ADAS-Cog
24 weeks
Secondary Outcomes (6)
MMSE (Mini-Mental State Examination)
24 weeks
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
24 weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
24 weeks
Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)
24 weeks
Caregiver burden scale
24 weeks
- +1 more secondary outcomes
Study Arms (2)
without white matter change
ACTIVE COMPARATORwith white matter change group
ACTIVE COMPARATORInterventions
rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks
Eligibility Criteria
You may qualify if:
- AD in NINCDS-ADRDA criteria, mild to moderate
- probable AD with or without mild to moderate whiter matter lesions, excluding multiple large vessel infarcts or a single, strategically placed infarct (angular gyrus, thalamus, basal forebrain, territory of the posterior or anterior cerebral artery) on MRI scan (within 12 months)
- MMSE score : 10 to 26 at screening
- Hachinski scores ≤ 4
- No clinically significant laboratory abnormalities, such as thyroid disease, vitamine B12 deficiency or folic acid deficiency
You may not qualify if:
- Current evidence of history of neurological, psychiatric and other illness that could contribute to dementia
- Subjects with clinical significant cardiovascular disease, stroke, pulmonary disease or any other medical disease in the past 6 months
- History of cancer within the last 5 years
- Subjects with evidence or history of clinically significant allergic reaction to AchEI or drugs
- Subjects who had significant visual or hearing difficulties
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dong-A Universitylead
- Novartis Korea Ltd.collaborator
Study Sites (16)
Holy Family Hospital, The Catholic Univerisy of Korea, School of Medicine
Bucheon-si, South Korea
Busan National University Hospital
Busan, South Korea
Busan Paik Hospital, Inje University College of Medicine
Busan, South Korea
Changwon Fatima Hospital
Changwon, South Korea
Daegu Fatima Hospital
Daegu, South Korea
Keimyung University School of Medicine
Daegu, South Korea
Kyungpook National University School of Medicine
Daegu, South Korea
Myongji Hospital, Kwandong University College of Medicine
Goyang, South Korea
Dongguk University International Hospital
Ilsan, South Korea
National Health Insurance Corporation Ilsan Hospital
Ilsan, South Korea
Inha University College of Medicine
Incheon, South Korea
Gyeongsang National University College of Medicine
Jinju, South Korea
Chonnam National University, Medical School
Kwangju, South Korea
Seoul National Unviersity College of Medicine, Clinical neuroscience center, Seoul National Unviersity Bundang Hospital
Seongnam, South Korea
The Catholic Univerisy of Korea, School of Medicine
Seoul, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
Related Publications (1)
Park KW, Kim EJ, Han HJ, Shim YS, Kwon JC, Ku BD, Park KH, Yi HA, Kim KK, Yang DW, Lee HW, Kang H, Kwon OD, Kim S, Lee JH, Chung EJ, Park SW, Park MY, Yoon B, Kim BC, Seo SW, Choi SH. Efficacy and tolerability of rivastigmine patch therapy in patients with mild-to-moderate Alzheimer's dementia associated with minimal and moderate ischemic white matter hyperintensities: A multicenter prospective open-label clinical trial. PLoS One. 2017 Aug 7;12(8):e0182123. doi: 10.1371/journal.pone.0182123. eCollection 2017.
PMID: 28786987DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung Won Park, MD, PhD
Dong-A University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
June 21, 2011
First Posted
June 27, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2016
Study Completion
December 31, 2017
Last Updated
February 5, 2018
Record last verified: 2018-02