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Rivastigmine Patch in Veterans With Cognitive Impairment Following TBI (RIVET)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01670526
First Posted: August 22, 2012
Last Update Posted: August 30, 2017
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.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: May 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Traumatic Brain Injury
Cognitive Impairment
Intervention: Drug: Rivastigmine Transdermal Patch

  Participant Flow
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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
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Reporting Groups
  Description
Rivastigmine

Rivastigmine transdermal patch

Rivastigmine Transdermal Patch: Cholinesterase Inhibitor

Placebo

Placebo

Rivastigmine Transdermal Patch: Cholinesterase Inhibitor


Participant Flow:   Overall Study
    Rivastigmine   Placebo
STARTED   49   45 
COMPLETED   37   39 
NOT COMPLETED   12   6 
Withdrawal by Subject                3                1 
Lost to Follow-up                9                5 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Rivastigmine

Rivastigmine transdermal patch

Rivastigmine Transdermal Patch: Cholinesterase Inhibitor

Placebo

Placebo

Rivastigmine Transdermal Patch: Cholinesterase Inhibitor

Total Total of all reporting groups

Baseline Measures
   Rivastigmine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   45   94 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      49 100.0%      45 100.0%      94 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2   4.1%      2   4.4%      4   4.3% 
Male      47  95.9%      43  95.6%      90  95.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      2   4.1%      0   0.0%      2   2.1% 
Asian      1   2.0%      0   0.0%      1   1.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      11  22.4%      4   8.9%      15  16.0% 
White      30  61.2%      34  75.6%      64  68.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      5  10.2%      7  15.6%      12  12.8% 
Region of Enrollment 
[Units: Participants]
     
United States   49   45   94 


  Outcome Measures
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1.  Primary:   Number of Participants With Demonstrated Improvement From Baseline on the Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall   [ Time Frame: week 12 ]

2.  Secondary:   Twelve-week Change in University of California San Diego Performance-based Skills Assessment - Brief (UPSA-B)   [ Time Frame: 12 weeks ]

3.  Secondary:   Twelve-week Change in The PTSD Symptom Checklist-Military Version (PCL-M)   [ Time Frame: 12 week ]

4.  Secondary:   Twelve-week Change in Beck Depression Inventory-II (BDI-II)   [ Time Frame: 12 week ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Tom Sindowski
Organization: Hines CSPCC
phone: 708-202-5858
e-mail: tom.sindowski@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01670526     History of Changes
Other Study ID Numbers: CLIN-003-10S
CCTA#0001 ( Other Identifier: VA )
First Submitted: August 1, 2012
First Posted: August 22, 2012
Results First Submitted: May 23, 2017
Results First Posted: July 25, 2017
Last Update Posted: August 30, 2017