ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01602198
Recruitment Status : Terminated (Study revised to use a different study medication and patient population.)
First Posted : May 18, 2012
Results First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor)
Conditions Mild Cognitive Disorder
Mild Cognitive Impairment
Interventions Drug: Exelon [rivastigmine] transdermal patch
Drug: Placebo transdermal patch
Enrollment 1

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exelon Transdermal Patch Placebo Transdermal Patch
Hide Arm/Group Description

Exelon [rivastigmine] transdermal patch

Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months

Placebo transdermal patch

Placebo patch: Placebo patch 1/day for 6 months

Period Title: Overall Study
Started 0 1
Completed 0 1
Not Completed 0 0
Arm/Group Title Exelon Transdermal Patch Placebo Transdermal Patch Total
Hide Arm/Group Description

Exelon [rivastigmine] transdermal patch

Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months

Placebo transdermal patch

Placebo patch: Placebo patch 1/day for 6 months

Total of all reporting groups
Overall Number of Baseline Participants 0 1 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
<=18 years 0
0
   0.0%
0
   0.0%
Between 18 and 65 years 0
0
   0.0%
0
   0.0%
>=65 years 0
1
 100.0%
1
 100.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
Female 0
1
 100.0%
1
 100.0%
Male 0
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
Hispanic or Latino 0
0
   0.0%
0
   0.0%
Not Hispanic or Latino 0
1
 100.0%
1
 100.0%
Unknown or Not Reported 0
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
American Indian or Alaska Native 0
0
   0.0%
0
   0.0%
Asian 0
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander 0
0
   0.0%
0
   0.0%
Black or African American 0
0
   0.0%
0
   0.0%
White 0
1
 100.0%
1
 100.0%
More than one race 0
0
   0.0%
0
   0.0%
Unknown or Not Reported 0
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 1 participants 1 participants
1 1
1.Primary Outcome
Title Change in BOLD Response on Functional Magnetic Resonance Imaging (fMRI)
Hide Description [Not Specified]
Time Frame baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Trial was terminated prematurely after enrollment of only 1 participant. Sample size is insufficient for BOLD response analysis.
Arm/Group Title Exelon Transdermal Patch Placebo Transdermal Patch
Hide Arm/Group Description:

Exelon [rivastigmine] transdermal patch

Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months

Placebo transdermal patch

Placebo patch: Placebo patch 1/day for 6 months

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected during the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exelon Transdermal Patch Placebo Transdermal Patch
Hide Arm/Group Description

Exelon [rivastigmine] transdermal patch

Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months

Placebo transdermal patch

Placebo patch: Placebo patch 1/day for 6 months

All-Cause Mortality
Exelon Transdermal Patch Placebo Transdermal Patch
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Exelon Transdermal Patch Placebo Transdermal Patch
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exelon Transdermal Patch Placebo Transdermal Patch
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      1/1 (100.00%)    
Cardiac disorders     
High blood pressure   0/0  0 1/1 (100.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Stephen Rao
Organization: Cleveland Clinic
Phone: 216-444-1025
EMail: raos2@ccf.org
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01602198     History of Changes
Other Study ID Numbers: AG022304
First Submitted: June 13, 2011
First Posted: May 18, 2012
Results First Submitted: January 9, 2017
Results First Posted: February 28, 2017
Last Update Posted: February 28, 2017