Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients

NeuroTherapia, Inc.

Status: Terminated

Conditions: Mild Cognitive Impairment; Mild Cognitive Disorder

Treatments: Drug: Placebo transdermal patch; Drug: Exelon [rivastigmine] transdermal patch

Study type: Interventional

Funder types: Other

Identifiers

NCT01602198

AG022304

Details and patient eligibility

About

The goal of this project is to determine if task-activated fMRI is sensitive to the central cholinergic deficit associated with Mild Cognitive Impairment.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

1 participants in 2 patient groups, including a placebo group

Exelon transdermal patch

Active Comparator group

Description:

Exelon \[rivastigmine\] transdermal patch

Treatment:

Drug: Exelon [rivastigmine] transdermal patch

Placebo transdermal patch

Placebo Comparator group

Description:

Placebo transdermal patch

Treatment:

Drug: Placebo transdermal patch