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Rivastigmine Transdermal Patch Treatment for Moderate to Severe Cognitive Impairment in Veterans with Traumatic Brain
Olga Brawman-Mintzer1,2, X Charlene Tang3, Marcel Bizien4
1Ralph H. Johnson VA Medical Center, Charleston, South Carolina, USA.
Journal of Neurotrauma
|January 30, 2021
Summary
Rivastigmine transdermal patches did not significantly improve memory in veterans with traumatic brain injury (TBI). This study found no significant difference in memory recall between the rivastigmine and placebo groups for TBI survivors.
Area of Science:
- Neuroscience
- Pharmacology
- Clinical Trials
Background:
- Cognitive impairment, particularly memory deficits, is prevalent in veterans following traumatic brain injury (TBI).
- Cholinergic system dysfunction is a potential contributing factor to post-TBI memory impairment.
- Understanding pharmacological interventions for TBI-related cognitive deficits is crucial for veteran healthcare.
Purpose of the Study:
- To evaluate the efficacy and safety of the rivastigmine transdermal patch for treating moderate to severe memory impairment in veterans at least 12 weeks post-TBI.
- To assess the impact of rivastigmine on verbal memory deficits using the Hopkins Verbal Learning Test, Revised (HVLT-R).
- To determine if rivastigmine offers a therapeutic benefit over placebo in this veteran population.
Main Methods:
- A 12-week, randomized, double-blind, placebo-controlled trial involving veterans with closed, non-penetrating TBI and verbal memory deficits.
- Participants received either rivastigmine patches (titrated from 4.6 mg/24h to 9.5 mg/24h) or matching placebo patches.
- The primary outcome measure was the proportion of participants achieving at least a five-word improvement on the HVLT-R Total Recall Index.
Main Results:
- Responder rates were 40.8% for rivastigmine versus 51.1% for placebo (p=0.41), indicating no significant difference.
- A mixed-effects model showed no significant treatment-by-time interaction (p=0.24).
- No significant differences were observed in secondary outcome measures between the rivastigmine and placebo groups. Application site reactions were the most common adverse events.
Conclusions:
- The rivastigmine transdermal patch did not demonstrate significant efficacy in improving verbal memory recall in veterans with TBI-related memory impairment.
- The study provides valuable data on the largest sample to date for a pharmacological trial in this specific veteran population.
- Further research may be needed to explore alternative or adjunctive treatments for cognitive deficits following TBI in veterans.
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