Galantamine Treatment for Nonfluent Aphasia in Stroke Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Galantamine Treatment for Nonfluent Aphasia in Stroke Patients|
- Spontaneous Speech [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]Analysis of spontaneous speech production with picture description (cookie theft picture): content units and lexical efficiency; as well as Boston Naming Test naming latency.
- ADP [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]Aphasia Diagnostic Profile: lexical Retrieval, phrase length, phonemic fluency, and category fluency.
- Communication Log scores [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]Subject communication change log scores Caregiver communication change log score
|Study Start Date:||October 2004|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
|Active Comparator: Galantamine||
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.
|Placebo Comparator: Placebo||
Drug: Placebo pill
Placebo pill each morning with food for 12 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129479
|Principal Investigator:||Heidi L Roth, MD||University of North Carolina|