Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
The goal of this project is to determine if task-activated fMRI is sensitive to the central cholinergic deficit associated with Mild Cognitive Impairment.

Condition or disease Intervention/treatment Phase
Mild Cognitive Disorder Mild Cognitive Impairment Drug: Exelon [rivastigmine] transdermal patch Drug: Placebo transdermal patch Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: 24-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Exelon® [Rivastigmine] Transdermal Patch in 120 APOE e4 Positive Amnestic MCI Patients
Study Start Date : June 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Exelon transdermal patch
Exelon [rivastigmine] transdermal patch
Drug: Exelon [rivastigmine] transdermal patch
Exelon patch 1/day for six months
Other Name: Rivastigmine

Placebo Comparator: Placebo transdermal patch
Placebo transdermal patch
Drug: Placebo transdermal patch
Placebo transdermal patch 1/day for 6 months
Other Name: Placebo patch

Primary Outcome Measures :
  1. Change in BOLD Response on Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: baseline and 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01602198

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Stephen M Rao The Cleveland Clinic

Responsible Party: The Cleveland Clinic Identifier: NCT01602198     History of Changes
Other Study ID Numbers: AG022304
First Posted: May 18, 2012    Key Record Dates
Results First Posted: February 28, 2017
Last Update Posted: February 28, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data to share.

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents