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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Dong-A University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Novartis Korea Ltd.
Information provided by (Responsible Party):
Kyungil Park, Dong-A University
ClinicalTrials.gov Identifier:
NCT01380288
First received: June 21, 2011
Last updated: August 14, 2012
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Alzheimer's Disease
 Drug: rivastigmine patch

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dong-A University:

Primary Outcome Measures:
  • The changes of cognitive function as measured by ADAS-Cog [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MMSE (Mini-Mental State Examination) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Caregiver burden scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: without white matter change Drug: rivastigmine patch
rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks
Other Name: Exelon patch
Active Comparator: with white matter change group Drug: rivastigmine patch
rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks
Other Name: Exelon patch

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380288

Locations
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
Kyungpook National University School of Medicine
Daegu, Korea, Republic of
Keimyung University School of Medicine
Daegu, Korea, Republic of
Myongji Hospital, Kwandong University College of Medicine
Goyang, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
Ilsan, Korea, Republic of
Dongguk University International 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, Korea, Republic of
Sponsors and Collaborators
Dong-A University
Novartis Korea Ltd.
Investigators
Principal Investigator: Kyung Won Park, MD, PhD Dong-A University
  More Information

No publications provided

Responsible Party: Kyungil Park, Assistant professor, Dong-A University
ClinicalTrials.gov Identifier: NCT01380288     History of Changes
Other Study ID Numbers: neuropark
Study First Received: June 21, 2011
Last Updated: August 14, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Dong-A University:
Alzheimer's disease
rivastigmine patch
white matter change

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013