NCT01602198

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Disorder
• Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Exelon [rivastigmine] transdermal patch	Exelon patch 1/day for six months
DRUG	Placebo transdermal patch	Placebo transdermal patch 1/day for 6 months

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-05-18
• Last updated: 2017-02-28
• Results posted: 2017-02-28

Locations

1 site across 1 country: United States