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Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients

This study has been terminated.
(Study revised to use a different study medication and patient population.)
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01602198
First received: June 13, 2011
Last updated: January 9, 2017
Last verified: December 2016
  Purpose
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 Intervention
Mild Cognitive Disorder Mild Cognitive Impairment Drug: Exelon [rivastigmine] transdermal patch Drug: Placebo transdermal patch

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

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

Enrollment: 1
Study Start Date: June 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602198

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

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01602198     History of Changes
Other Study ID Numbers: AG022304
Study First Received: June 13, 2011
Results First Received: January 9, 2017
Last Updated: January 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data to share.

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

ClinicalTrials.gov processed this record on September 21, 2017