CCTA #0001: Rivastigmine Patch in Veterans with Cognitive Impairment Following TBI (RIVET) - VA Cooperative Studies Program (CSP)
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VA Cooperative Studies Program (CSP)

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CCTA #0001: Rivastigmine Patch in Veterans with Cognitive Impairment Following TBI (RIVET)

 

Data Sharing Statement

What's available?

Pending

Available Documentation

Pending

Dates Data are Available

Pending

Access Criteria

Pending

Study Characteristics

Objectives

To evaluate the efficacy and safety of rivastigmine transdermal patch, an intermediate-acting cholinesterase inhibitor, in Veterans with traumatic brain injuries (TBI) and posttraumatic memory problem

Era of Service

All

Population

Veterans suffering from moderate-to-severe posttraumatic memory impairment following TBI

Study Design

Randomized, quadruple-blinded, two-arm, intent-to-treat, parallel clinical trial

Intervention 

  • Active comparator: Rivastigmine transdermal patch 
  • Placebo comparator: Placebo transdermal patch 

Time Period

December 2012 - September 2017

Setting

National

N

94 (49 participants receiving rivastigmine, 45 participants receiving placebo)

Response Rate

N/A

Recruitment Method

Participants were recruited from 5 VA medical centers through these methods:

  • Provider referrals from specific outpatient clinics
  • Review of VA administrative databases
  • Posted flyers
  • Mailed recruitment letters

Interested individuals were requested to call the research study coordinators, screened via telephone interview, and subsequently asked to provide written consent.

Compensation

  • $40 for each in-person visit
  • $10 for phone visits

Data Collected

Primary outcomes

  • Improvements in verbal learning and memory (assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Index)

Secondary outcomes

  • Impact of rivastigmine-mediated memory improvements measured by change in University of California San Diego Performance-based Skills Assessment-Brief (UPSA-B)
  • Change in Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) symptoms of PTSD measured by Checklist-Military Version (PCL-M)
  • Severity of depressive symptoms measured by change in Beck Depression Inventory-II (BDI-II)

Other assessments

  • Demographics and clinical characteristics

Data Collection Methods 

  • In-person visits with trained coordinators, study clinicians, and independent clinicians
  • Questionnaires
  • Related documents from the study sites, and from non-VA records

Funding Source

VA Cooperative Studies Program (CSP), Cooperative Clinical Trial Award (CCTA) Program

Contact

Tom.Sindowski@va.gov

Selected Publication

Pending

More Information

Study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT01670526