Galantamine Treatment for Nonfluent Aphasia in Stroke Patients
|ClinicalTrials.gov Identifier: NCT01129479|
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : May 24, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Aphasia Stroke||Drug: Galantamine Drug: Placebo pill||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Galantamine Treatment for Nonfluent Aphasia in Stroke Patients|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
|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.
- Spontaneous Speech [ Time Frame: Every 4 weeks ]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 ]Aphasia Diagnostic Profile: lexical Retrieval, phrase length, phonemic fluency, and category fluency.
- Communication Log scores [ Time Frame: Every 12 weeks ]Subject communication change log scores Caregiver communication change log score
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129479
|Principal Investigator:||Heidi L Roth, MD||University of North Carolina|