Cognitive Changes in Alzheimer's Disease Patients Associated With or Without White Matter Changes After Rivastigmine

NCT ID: NCT01380288

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2017-12-31

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.

Detailed 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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

without white matter change

Group Type: ACTIVE_COMPARATOR

rivastigmine patch

Intervention Type: DRUG

rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks

with white matter change group

Group Type: ACTIVE_COMPARATOR

rivastigmine patch

Intervention Type: DRUG

rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks

Interventions

rivastigmine patch

rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks

Intervention Type: DRUG

Other Intervention Names

Exelon patch

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Korea Ltd.

INDUSTRY

Sponsor Role: collaborator

Dong-A University

OTHER

Sponsor Role: lead

Responsible Party

Kyungil Park

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyung Won Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dong-A University

Locations

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

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 28786987 (View on PubMed)

Other Identifiers

neuropark

Identifier Type: -

Identifier Source: org_study_id