Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment

Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment

This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with traumatic brain injury and cognitive impairment.

Inclusion Criteria:

• Traumatic brain injury confirmed by available brain imaging (CT or MRI) and be at least 52 weeks post injury
• Neuropsychologic disturbances indicated by: impaired memory (reduction of below 1 standard deviation (SD) of the mean on the California Verbal Learning Test (CVLT) and impaired executive function (reduction of below 1 standard deviation (SD) of the mean on the Verbal Memory Learning Test (VLMT) and Tower of London Test (ToL) and impaired attention (reduction of below 1 standard deviation (SD) of the mean on the Test Battery for Attentional Performance (TAP)
• Be required to have had sufficient education to read, write, and effectively communicate
• Be cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver according to the investigator's judgement

Exclusion Criteria:

• A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances
• A current diagnosis of active, uncontrolled seizure disorder or major depression, or any other diagnosis that may interfere with the patient's response to study medication
• An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations
• Female patients with child-bearing potential who are breast-feeding, pregnant or not practicing non-hormonal contraception

Other protocol-defined inclusion/exclusion criteria may apply.