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

Alzheimer's Disease Clinical Trial

— CAREER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380288
• Other study ID #: neuropark
• Status: Completed
• Phase: N/A
• First received: June 21, 2011
• Last updated: February 2, 2018
• Start date: June 2011
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• Source: Dong-A University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Holy Family Hospital, The Catholic Univerisy of Korea, School of Medicine	Bucheon
Korea, Republic of	Busan National University Hospital	Busan
Korea, Republic of	Busan Paik Hospital, Inje University College of Medicine	Busan
Korea, Republic of	Changwon Fatima Hospital	Changwon
Korea, Republic of	Daegu Fatima Hospital	Daegu
Korea, Republic of	Keimyung University School of Medicine	Daegu
Korea, Republic of	Kyungpook National University School of Medicine	Daegu
Korea, Republic of	Myongji Hospital, Kwandong University College of Medicine	Goyang
Korea, Republic of	Dongguk University International Hospital	Ilsan
Korea, Republic of	National Health Insurance Corporation Ilsan Hospital	Ilsan
Korea, Republic of	Inha University College of Medicine	Incheon
Korea, Republic of	Gyeongsang National University College of Medicine	Jinju
Korea, Republic of	Chonnam National University, Medical School	Kwangju
Korea, Republic of	Seoul National Unviersity College of Medicine, Clinical neuroscience center, Seoul National Unviersity Bundang Hospital	Seongnam
Korea, Republic of	The Catholic Univerisy of Korea, School of Medicine	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (2)

Lead Sponsor	Collaborator
Dong-A University	Novartis Korea Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of cognitive function as measured by ADAS-Cog		24 weeks
Secondary	MMSE (Mini-Mental State Examination)		24 weeks
Secondary	Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)		24 weeks
Secondary	Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)		24 weeks
Secondary	Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)		24 weeks
Secondary	Caregiver burden scale		24 weeks
Secondary	Adverse events		24 weeks