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

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ClinicalTrials.gov Identifier: NCT01380288
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
Novartis Korea Ltd.
Information provided by (Responsible Party):
Kyungil Park, Dong-A University

Tracking Information
First Submitted Date  ICMJE June 21, 2011
First Posted Date  ICMJE June 27, 2011
Last Update Posted Date February 5, 2018
Actual Study Start Date  ICMJE June 2011
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
The changes of cognitive function as measured by ADAS-Cog [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01380288 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Changes in Alzheimer's Disease Patients Associated With or Without White Matter Changes After Rivastigmine
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: rivastigmine patch
rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks
Other Name: Exelon patch
Study Arms  ICMJE
  • Active Comparator: without white matter change
    Intervention: Drug: rivastigmine patch
  • Active Comparator: with white matter change group
    Intervention: Drug: rivastigmine patch
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2011)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01380288
Other Study ID Numbers  ICMJE neuropark
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyungil Park, Dong-A University
Study Sponsor  ICMJE Dong-A University
Collaborators  ICMJE Novartis Korea Ltd.
Investigators  ICMJE
Principal Investigator: Kyung Won Park, MD, PhD Dong-A University
PRS Account Dong-A University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP