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Rivastigmine Patch in Veterans With Cognitive Impairment Following TBI
NCT01670526 · View on ClinicalTrials.gov ↗
Study Summary
Difficulties with intellectual functioning, particularly memory functions, are common and source of long-term disability after Traumatic Brain Injury (TBI). However, there is very little information about pharmacologic (i.e., medication) treatments targeting these deficits. There are growing data showing brain abnormalities in acetylcholine, the chemical system that manages memory, in TBI. These findings provide the rationale for the use of cholinesterase inhibitors, medications that modulate this system, in TBI patients. As the prevalence of TBI among Veterans of recent military conflicts increases, becoming a "signature injury" of the Iraq and Afghanistan conflicts, it is of utmost importance to the Veterans Health Administration to collect scientific data on the efficacy of pharmacological treatments for intellectual difficulties in TBI patients. This study will evaluate the effects of the cholinesterase inhibitor rivastigmine transdermal patch in Veterans with TBI and posttraumatic memory problems. Results will provide much needed data that will help treat Veterans with TBI.
Conditions Studied
Interventions
- DRUG Rivastigmine Transdermal Patch
Study Locations (8)
Florida
- Miami VA Healthcare System, Miami, FL — Miami
- James A. Haley Veterans' Hospital, Tampa, FL — Tampa
California
- VA San Diego Healthcare System, San Diego, CA — San Diego
Illinois
- Edward Hines Jr. VA Hospital, Hines, IL — Hines
Nebraska
- Lincoln Community-Based Outpatient Clinic, Lincoln, NE — Lincoln
South Carolina
- Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston
Texas
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston
Utah
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2012-12 |
| Est. Completion | 2017-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01670526
The ClinicalTrials.gov registry entry for NCT01670526 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention — of which Rivastigmine Transdermal Patch is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01670526 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01670526 about?
NCT01670526 is a clinical study titled "Rivastigmine Patch in Veterans With Cognitive Impairment Following TBI". Difficulties with intellectual functioning, particularly memory functions, are common and source of long-term disability after Traumatic Brain Injury (TBI). However, there is very little information about pharmacologic (i.e., medication) treatments targeting these deficits. There are growing data sh...
What is the current status of trial NCT01670526?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 94 participants. The study started on 2012-12. Estimated completion is 2017-09.
What conditions does trial NCT01670526 study?
This clinical trial studies the following conditions: Traumatic Brain Injury, Cognitive Impairment. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01670526?
The interventions under investigation include: Rivastigmine Transdermal Patch (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01670526?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01670526 being conducted?
This trial has 8 study locations across California, Florida, Illinois, Nebraska, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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