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Patients who completed the 12-week double blind protocol may enter this 26-week, open-label extension. This extension will give patients who complete the study an opportunity to receive treatment with open-label rivastigmine 3-12 mg/day and further evaluation for the cognitive deficits related to traumatic brain injury. This extension will enable further evaluation of patients, as well as analyses to be conducted examining response to treatments in the original drug and placebo groups.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in cognitive functioning in the areas of attention or verbal memory from baseline to week 26 | ||
| Safety and tolerability of 26 week's of treatment with rivastigmine in patients with traumatic brain injury with persistent cognitive impairment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cognitive functioning from baseline to week 26 | ||
| Changes in behavior from baseline to week 26 | ||
| Changes in depression from baseline to week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Sponsor GmbH | Study Director |
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| Changes in quality of life from baseline to week 26 |
| Changes in overall functioning from baseline to week 26 |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D006259 | Craniocerebral Trauma |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068836 | Rivastigmine |
| ID | Term |
|---|---|
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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