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Long-term effects of rivastigmine capsules in patients with traumatic brain injury


Silver, Jonathan M., Koumaras, Barbara, Meng, Xiangyi, Potkin, Steven G., Reyes, Patricio F., Harvey, Philip D., Katz, Douglas I., Gunay, Ibrahim, Arciniegas, David B.


Brain Injury, Volume: 23, No.: 2, Pages.: 123-132

Year of Publication



Objective: To investigate the safety, tolerability and efficacy of rivastigmine capsules (3-12 mg/day) in a 26-week, multi-centre, open-label extension of a double-blind study.; Methods: Patients with traumatic brain injury (TBI) and persistent cognitive impairment who had received rivastigmine (3-6 mg/day) or placebo for 12 weeks could enter the extension study and receive rivastigmine (< or =12 mg/day). Patients were assessed using a range of cognitive tests including the Hopkins Verbal Learning Test (HVLT) and the Cambridge Neuropsychological Test Automated Battery Rapid Visual Information Processing (CANTAB RVIP) A' sub-test. Safety measures included monitoring of adverse events.; Results: In the extension study (n = 127), the mean duration of rivastigmine treatment was 23.8 weeks and the mean final dosage was 7.9 mg/day. Approximately 40% of patients were responders (> or =1.0 SD improvement from baseline) on CANTAB RVIP A’ or HVLT total score at week 38 or endpoint. Statistically significant changes from week 12 at week 38 were observed for CANTAB-RVIP A’ and HVLT-total word recall for the sub-group of ex-placebo patients with greater severity of initial impairment. The safety profile of rivastigmine capsules was consistent with the label.; Conclusions: Treatment with rivastigmine for up to 38 weeks was safe in patients with TBI and cognitive impairment.;

Bibtex Citation

@article{Silver_2009, doi = {10.1080/02699050802649696}, url = {}, year = 2009, month = {jan}, publisher = {Informa {UK} Limited}, volume = {23}, number = {2}, pages = {123--132}, author = {Jonathan M. Silver and Barbara Koumaras and Xiangyi Meng and Steven G. Potkin and Patricio F. Reyes and Philip D. Harvey and Douglas I. Katz and Ibrahim Gunay and David B. Arciniegas}, title = {Long-term effects of rivastigmine capsules in patients with traumatic brain injury}, journal = {Brain Injury} }


administration & dosage, adult, adverse effects, brain, brain injuries, capsules, cognition disorders, complications, double-blind method, drug, drug administration schedule, drug therapy, female, humans, injury, male, middle aged, neuroprotective agents, neuropsychological tests, phenylcarbamates, physiopathology, rivastigmine, safety, time, traumatic, treatment outcome

Countries of Study


Types of Study

Randomised Controlled Trial

Type of Outcomes


Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime