Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis Korea Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Acetylcholinesterase inhibitors (AChEIs) increase the amount acetylcholine at ACh receptors within the brain, and are the primary medications used to treat AD. Alzheimer's disease patients are frequently associated with mild or moderate white matter changes on MR imaging. The impact of whiter matter changes on the efficacy of cognition, functional abilities, behavioral and psychiatric symptoms and caregiver burden for probable Alzheimer's disease is not well known. There are very few studies for the efficacy of rivastigmine between the patients with mild to moderate Alzheimer's disease associated with or without vascular risk factors.
Recently, the rivastigmine patch demonstrated efficacy comparable to the highest doses of rivastigmine capsules, with markedly improved tolerability profile. The investigators hypothesized that rivastigmine patch will provide benefits to AD patients with white matter changes compared to those without any white matter changes. Possible explanation about favorable benefits for AD with white matter changes is that rivastigmine may act on both Alzheimer's and vascular pathologies contributing to dementia, providing additive treatment effects in patients suffering from both conditions concurrently. To our Knowledge, there was no study or clinical trial to compare the changes of cognitive function, ADL, BPSD and caregiver burden in two groups of patient with Alzheimer's disease associated with or without white matter changes after rivastigmine transdermal patch therapy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| without white matter change | Active Comparator |
| |
| with white matter change group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rivastigmine patch | Drug | rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The changes of cognitive function as measured by ADAS-Cog | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyung Won Park, MD, PhD | Dong-A University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Family Hospital, The Catholic Univerisy of Korea, School of Medicine | Bucheon-si | South Korea | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28786987 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 24 weeks |
| Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) | 24 weeks |
| Caregiver burden scale | 24 weeks |
| Adverse events | 24 weeks |
| 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 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided