drugset / Trial / NCT01670526

Rivastigmine Patch in Veterans With Cognitive Impairment Following TBI

NCT01670526

Phase 3 Completed 94 enrolled VA Office of Research and Development
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-12
Primary completion
2016-06
Completion
2017-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivastigmine Small molecule 9.5 mg Other