Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine

Primary Measures

• 20 week's treatment with rivastigmine on selective attention compared with placebo in patients with TBI and cognitive impairment

Secondary Measures

• Safety of rivastigmine
• Change from baseline to week 20 in cognitive functioning including selective attention, memory, executive function, and global clinical rating

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharma Study Director Novartis  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171795

Study ID Number: CENA713BDE01

ClinicalTrials.gov Identifier: NCT00171795

Health Authority: Germany: Federal Institute for Drugs and Medical Devices