Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients

Not Applicable

Terminated

• Conditions: Mild Cognitive Disorder; Mild Cognitive Impairment
• Interventions: Drug: Exelon [rivastigmine] transdermal patch; Drug: Placebo transdermal patch

• Registration Number: NCT01602198
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-18
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2016-12
• Results First Submitted: 2017-01-09
• Results First Submitted QC: 2017-01-09
• Last Update Submitted: 2017-01-09
• Results First Posted: 2017-02-28
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exelon transdermal patch	Exelon [rivastigmine] transdermal patch	Exelon \[rivastigmine\] transdermal patch
Placebo transdermal patch	Placebo transdermal patch	Placebo transdermal patch

Primary Outcome Measures

Name	Time	Method
Change in BOLD Response on Functional Magnetic Resonance Imaging (fMRI)	baseline and 6 months

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States