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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks
Holy Family Hospital, The Catholic Univerisy of Korea, School of Medicine
Bucheon-si, South Korea
Busan National University Hospital
Busan, South Korea
The changes of cognitive function as measured by ADAS-Cog
Time frame: 24 weeks
MMSE (Mini-Mental State Examination)
Time frame: 24 weeks
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Time frame: 24 weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time frame: 24 weeks
Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)
Time frame: 24 weeks
Caregiver burden scale
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
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