This trial is active, not recruiting.

Condition alzheimer's disease
Treatment rivastigmine patch
Sponsor Dong-A University
Collaborator Novartis Korea Ltd.
Start date June 2011
End date December 2012
Trial size 300 participants
Trial identifier NCT01380288, neuropark


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
rivastigmine patch Exelon patch
rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks
(Active Comparator)
rivastigmine patch Exelon patch
rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks

Primary Outcomes

The changes of cognitive function as measured by ADAS-Cog
time frame: 24 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 50 years up to 90 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title 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
Principal investigator Kyung Won Park, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Dong-A University.