- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01602198
Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients
January 9, 2017 updated by: The Cleveland Clinic
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
53 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exelon transdermal patch
Exelon [rivastigmine] transdermal patch
|
Exelon patch 1/day for six months
Other Names:
|
Placebo Comparator: Placebo transdermal patch
|
Placebo transdermal patch 1/day for 6 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in BOLD Response on Functional Magnetic Resonance Imaging (fMRI)
Time Frame: baseline and 6 months
|
baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen M Rao, The Cleveland Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
June 13, 2011
First Submitted That Met QC Criteria
May 16, 2012
First Posted (Estimate)
May 18, 2012
Study Record Updates
Last Update Posted (Actual)
February 28, 2017
Last Update Submitted That Met QC Criteria
January 9, 2017
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Neurocognitive Disorders
- Cognitive Dysfunction
- Cognition Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Neuroprotective Agents
- Protective Agents
- Cholinesterase Inhibitors
- Rivastigmine
Other Study ID Numbers
- AG022304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No data to share.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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