Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients

NCT ID: NCT01602198

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-01-31

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.

Conditions

Mild Cognitive Disorder; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Exelon transdermal patch

Exelon \[rivastigmine\] transdermal patch

Group Type: ACTIVE_COMPARATOR

Exelon [rivastigmine] transdermal patch

Intervention Type: DRUG

Exelon patch 1/day for six months

Placebo transdermal patch

Placebo transdermal patch

Group Type: PLACEBO_COMPARATOR

Placebo transdermal patch

Intervention Type: DRUG

Placebo transdermal patch 1/day for 6 months

Interventions

Exelon [rivastigmine] transdermal patch

Exelon patch 1/day for six months

Intervention Type: DRUG

Placebo transdermal patch

Placebo transdermal patch 1/day for 6 months

Intervention Type: DRUG

Other Intervention Names

Rivastigmine; Placebo patch

Eligibility 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen M Rao

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

AG022304

Identifier Type: -

Identifier Source: org_study_id