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| Name | Class |
|---|---|
| Ortho-McNeil Neurologics, Inc. | INDUSTRY |
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Cognitive impairment after stroke is common and has a major effect on morbidity and quality of life. Acetylcholinesterase inhibitors have demonstrated benefit in vascular dementia, but efficacy in treating more circumscribed cognitive deficits following stroke, such as aphasia, has not been systematically investigated.
This study evaluated the efficacy of Galantamine (Reminyl) in subjects with chronic, stable non-fluent aphasia secondary to stroke. Subjects enrolled in a double-blind placebo- controlled cross-over study that employed a comprehensive battery of language tests and measures of general cognitive and behavioral status that will be used to control for factors that may influence language functioning. The primary study outcome was a within-subject comparison of changes in language function and behavioral scores between placebo and active-treatment phases (12 weeks each). Our hypothesis was that by increasing acetylcholine levels, and facilitating activity of other neurotransmitters affecting attentional systems, Galantamine would produce gains in both language and behavioral scores in patients suffering chronic effects in cognitive systems due to injury following stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galantamine | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galantamine | Drug | Galantamine XL 8 mg for 4 weeks, followed by Galantamine XL 16 mg for subsequent 12 weeks. Taken in the morning with food for total of 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous Speech | Analysis of spontaneous speech production with picture description (cookie theft picture): content units and lexical efficiency; as well as Boston Naming Test naming latency. | Every 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ADP | Aphasia Diagnostic Profile: lexical Retrieval, phrase length, phonemic fluency, and category fluency. | Every 4 weeks |
| Communication Log scores | Subject communication change log scores Caregiver communication change log score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi L Roth, MD | University of North Carolina | Principal Investigator |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D005702 | Galantamine |
| ID | Term |
|---|---|
| D047151 | Amaryllidaceae Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
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|
| Placebo pill | Drug | Placebo pill each morning with food for 12 weeks. |
|
| Every 12 weeks |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |