Study Stopped
Study revised to use a different study medication and patient population.
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
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 13, 2011
CompletedFirst Posted
Study publicly available on registry
May 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
February 28, 2017
CompletedFebruary 28, 2017
December 1, 2016
1.6 years
June 13, 2011
January 9, 2017
January 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in BOLD Response on Functional Magnetic Resonance Imaging (fMRI)
baseline and 6 months
Study Arms (2)
Exelon transdermal patch
ACTIVE COMPARATORExelon \[rivastigmine\] transdermal patch
Placebo transdermal patch
PLACEBO COMPARATORPlacebo transdermal patch
Interventions
Exelon patch 1/day for six months
Placebo transdermal patch 1/day for 6 months
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephen Rao
- Organization
- Cleveland Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen M Rao
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2011
First Posted
May 18, 2012
Study Start
June 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
February 28, 2017
Results First Posted
February 28, 2017
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share
No data to share.