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Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Exelon Transdermal Patch

Exelon [rivastigmine] transdermal patch

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

Placebo Transdermal Patch

Placebo transdermal patch

Placebo patch: Placebo patch 1/day for 6 months


Participant Flow:   Overall Study
    Exelon Transdermal Patch   Placebo Transdermal Patch
STARTED   0   1 
COMPLETED   0   1 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Exelon Transdermal Patch

Exelon [rivastigmine] transdermal patch

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

Placebo Transdermal Patch

Placebo transdermal patch

Placebo patch: Placebo patch 1/day for 6 months

Total Total of all reporting groups

Baseline Measures
   Exelon Transdermal Patch   Placebo Transdermal Patch   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   1   1 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female   0      1 100.0%      1 100.0% 
Male   0      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States      1   1 


  Outcome Measures

1.  Primary:   Change in BOLD Response on Functional Magnetic Resonance Imaging (fMRI)   [ Time Frame: baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: 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