Abstract for presentation at 6th World Congress on Brain Injury

Use of Rivastigmine in Patients with Traumatic Brain Injury with Cognitive Deficits: A Pilot Study

  • Dario Mirski, Novartis Pharmaceuticals, United States
  • Dr Jonathan Silver, New York University School of Medicine, United States
  • Dr Adrian Rabinowicz, Novartis Pharmaceuticals, United States
  • Barbara Koumaras, Novartis Pharmaceuticals, United States
  • Dr Michael Chen, Novartis Pharmaceuticals, United States
  • Dr Steven Potkin, University of California, Irvine Medical Center, United States
  • Dr David Arciniegas, University of Colorado Health Sciences Center, United States
  • Dr Patricio Reyes, Creighton University School of Medicine, United States

    • Introduction: Closed brain injury, (non-penetrating traumatic brain injury [TBI]) is a significant medical problem, with many patients having persistent cognitive deficits or other neuropsychiatric disorders. This study tests the hypothesis that enhancement of central cholinergic activity using rivastigmine improves cognitive, memory, attention and behavioral deficits secondary to TBI.
    Methods: This was a 12-week prospective, randomized, double-blind, placebo-controlled multi-center pilot study assessing the safety and efficacy of rivastigmine in patients with non-penetrating TBI with persistent cognitive deficits of at least 1 year duration. The primary objective was to compare the effects of rivastigmine 3 to 6 mg/day versus placebo on measures of attention or memory as assessed with the Hopkins Verbal Learning Test (HVLT) trials 1-3 total score, or the Cambridge Neuropsychological Test Automated Battery (CANTAB). Another objective was to assess the safety and tolerability of rivastigmine compared to placebo. The results reported here describe patient demographics. Results for the primary efficacy and safety parameters will be reported in the poster presentation.
    Results: The study population consisted of 157 patients, 106 males and 51 females. The mean age was 37 years (range 18 to 55). Patients satisfied the ICD-9-CM 854.0 criteria for TBI, 89% were Caucasian, and the mean education was 14 years. 86% of the patients had a known loss of consciousness (LOC; mean duration, 23 days) associated with the TBI, and 76 patients (48%) had a Glasgow Coma Scale (GCS; mean score, 6.5) score collected within 24 hours of the injury. 85% of patients reported a loss of memory, and 92% experienced an alteration in their mental state.
    Conclusion: These demographic results present a sample of non-penetrating TBI patients with persistent cognitive deficits for at least 12 months following their injury. The subject population appears to be representative of individuals with moderate to severe TBI. This study demonstrates the feasibility of conducting rigorous clinical trials in this significant, underserved population.

    Conference Organiser - ICMS Pty Ltd