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Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients

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ClinicalTrials.gov Identifier: NCT01602198
Recruitment Status : Terminated (Study revised to use a different study medication and patient population.)
First Posted : May 18, 2012
Results First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

June 13, 2011
May 18, 2012
January 9, 2017
February 28, 2017
February 28, 2017
June 2011
January 2013   (Final data collection date for primary outcome measure)
Change in BOLD Response on Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: baseline and 6 months ]
Same as current
Complete list of historical versions of study NCT01602198 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients
24-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Exelon® [Rivastigmine] Transdermal Patch in 120 APOE e4 Positive Amnestic MCI Patients
The goal of this project is to determine if task-activated fMRI is sensitive to the central cholinergic deficit associated with Mild Cognitive Impairment.
Clinical studies suggest that cholinesterase inhibitors (ChEIs) exert a cognitive benefit with chronic use among MCI and AD patients. Some studies also demonstrate a slight treatment benefit for persons who are APOE 4 positive. We propose to conduct a 24-week, randomized, double-blind, placebo-controlled, parallel group study of the Exelon® [rivastigmine] transdermal patch in 120 aMCI patients who have one or both APOE 4 alleles. Our preliminary analyses indicate that aMCI patients, even those who convert to AD, exhibit increased fMRI activation on our semantic memory activation task relative to not at-risk healthy participants and that increasing activation over time correlates with declines on neuropsychological testing. In addition, our preliminary data indicate that ChEI treated aMCI patients demonstrate normalization (i.e. reduction) in the magnitude of task-related neural activation over time relative to an untreated group. Furthermore, changes in fMRI magnitude demonstrated greater sensitivity to cholinergic modulation than changes on neuropsychological testing.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
  • Mild Cognitive Disorder
  • Mild Cognitive Impairment
  • Drug: Exelon [rivastigmine] transdermal patch
    Exelon patch 1/day for six months
    Other Name: Rivastigmine
  • Drug: Placebo transdermal patch
    Placebo transdermal patch 1/day for 6 months
    Other Name: Placebo patch
  • Active Comparator: Exelon transdermal patch
    Exelon [rivastigmine] transdermal patch
    Intervention: Drug: Exelon [rivastigmine] transdermal patch
  • Placebo Comparator: Placebo transdermal patch
    Placebo transdermal patch
    Intervention: Drug: Placebo transdermal patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
120
January 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of amnestic MCI
  • In good general health with no diseases expected to interfere with the study
  • Ability to undergo MRI
  • Fluent in English
  • Stable prescription dosages 1 month prior to testing
  • Carrier of the APOE e4 allele (determined by blood draw at screening visit)

Exclusion Criteria:

  • Neurological illness/conditions
  • Medical illnesses/conditions that may affect brain function
  • Prior history of use of any cholinesterase inhibitor
  • Instable or severe cardiovascular disease or asthmatic condition
Sexes Eligible for Study: All
55 Years to 85 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01602198
AG022304
No
Not Provided
Plan to Share IPD: No
Plan Description: No data to share.
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Stephen M Rao The Cleveland Clinic
The Cleveland Clinic
December 2016

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