Clinical Trial: Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

Brief Summary:

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.


Detailed Summary:
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: May 21, 2010
Date Started: October 2004
Date Completion:
Last Updated: May 21, 2010
Last Verified: May 2010