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

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

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

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Drug: Rivastigmine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rivastigmine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 20 week's treatment with rivastigmine on selective attention compared with placebo in patients with TBI and cognitive impairment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of rivastigmine |  |  | 
| Change from baseline to week 20 in cognitive functioning including selective attention, memory, executive function, and global clinical rating |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury,, cognitive impairment,, rivastigmine