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Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients

This study is currently recruiting participants.
Verified December 2012 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01602198
First received: June 13, 2011
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Mild Cognitive Disorder
Mild Cognitive Impairment
 Drug: Exelon [rivastigmine] transdermal patch
Drug: Placebo patch

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Change in BOLD response on Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exelon transdermal patch
Exelon [rivastigmine] transdermal patch
 Drug: Exelon [rivastigmine] transdermal patch
Exelon patch 1/day for six months
Placebo Comparator: Placebo transdermal patch
Placebo transdermal patch
 Drug: Placebo patch
Placebo patch 1/day for 6 months

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602198

Contacts
Contact: Christine Reece, B.S., CCRP 216-445-9009 raolab@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Christine Reece, M.S., CCRP     216-445-9009     raolab@ccf.org    
Principal Investigator: Stephen M Rao, Ph.D.            
Sponsors and Collaborators
The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01602198     History of Changes
Other Study ID Numbers: AG022304
Study First Received: June 13, 2011
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013