CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 94 enrolled
Drug / intervention
Rivastigmine Transdermal Patchdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01670526
NCT01670526Phase 3Completed

Rivastigmine Patch in Veterans With Cognitive Impairment Following TBI

VA Office of Research and Development·interventional·Posted Aug 22, 2012·Updated Feb 27, 2018

In Brief

A Phase 3 clinical trial evaluating Rivastigmine Transdermal Patch for Traumatic Brain Injury and Cognitive Impairment. Completed, enrolled 94 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 22, 2012
Enrollment StartDec 1, 2012
Primary CompletionJun 1, 2016
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 13.9 years ago

Interventions

Rivastigmine Transdermal Patchdrug

Cholinesterase Inhibitor