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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)

 

Investigator Access

What's Available

 

  

 
Check with the study contact and publications for information on a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation

Dates Data are Available

Access Criteria

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 participants (rivastigmine n=49, placebo n=45)

Response Rate

Unconfirmed

Recruitment Methods

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 Sources

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

Investigator

Principal Investigator: Olga Brawman-Mintzer, MD; Olga.Brawman-Mintzer@va.gov

Contact

Project Manager: Tom Sindowski; Tom.Sindowski@va.gov

Selected Publications

Unconfirmed

More Information
  • Study ClinicalTrials.gov site
  • ClinicalTrials.gov Identifier: NCT01670526
  • Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)





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