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NCT01670526 · ClinicalTrials.gov registry record · Phase 3
Rivastigmine Patch in Veterans With Cognitive Impairment Following TBI
A Phase 3 study of Traumatic Brain Injury and Cognitive Impairment, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 94
- Enrollment target
- 8
- Study locations
NCT01670526 is a Phase 3 study of Traumatic Brain Injury and Cognitive Impairment that has completed, run by VA Office of Research and Development. The registered enrollment target is 94 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (66% lower). The trial reports 8 study locations across 7 states.
The verdict
NCT01670526, a Phase 3 study of Traumatic Brain Injury and Cognitive Impairment, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 94 participants
- Enrollment target
- 8
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (66% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
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.
NCT01670526 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Illinois.
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.
What interventions are being tested in trial NCT01670526?
The interventions under investigation include: Rivastigmine Transdermal Patch (DRUG).
Who is sponsoring clinical trial NCT01670526?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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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Related
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