Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients

Mild Cognitive Impairment Clinical Trial

Official title:

24-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Exelon® [Rivastigmine] Transdermal Patch in 120 APOE e4 Positive Amnestic MCI Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01602198
• Other study ID #: AG022304
• Status: Terminated
• Phase: N/A
• First received: June 13, 2011
• Last updated: February 21, 2014
• Start date: June 2011
• Est. completion date: May 2015

Study information

• Verified date: February 2014
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Disorder
• Mild Cognitive Impairment

Intervention

Drug:
• Exelon [rivastigmine] transdermal patch
Exelon patch 1/day for six months
• Placebo patch
Placebo patch 1/day for 6 months

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BOLD response on Functional Magnetic Resonance Imaging (fMRI)		baseline and 6 months	No