Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

Last updated: May 21, 2010
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Completed

Phase

N/A

Condition

Stroke

Communication Disorders

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT01129479
GAL-EMR-4008
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of aphasia with relatively spared comprehension.

  • Onset 6 months or greater prior to enrollment.

  • Native English speaker

  • Right-handed.

  • Adults (18 years of age or older).

Exclusion

Exclusion Criteria:

  • Patients receiving ongoing individual speech therapy. (Most patients are no longereligible for individualized speech therapy after 6 months from stroke onset, thus thisshould not eliminate many patients).

  • Extremely mild or extremely severe aphasia. (Boston Naming Test Score <3 or >45 itemsnamed from 60 items).

  • Global dementia (and any other patient with reduced decisional capacity requiring alegally authorized representative for consent).

  • Presence of major cognitive deficit other than aphasia caused by stroke relateddisease.

  • Contraindications to cholinomimetic agents: History of active peptic ulcer diseasewithin 1 year, Severe asthma, unstable angina, bradyarrhythmia with resting pulse lessthan 50, sick sinus syndrome, or seizures.

  • Major psychiatric disorders that affect cognition including: psychosis, majordepression, bipolar disorder, alcohol or substance abuse.

  • Major medical conditions that alter cognition (e.g., heart failure, dialysis dependentrenal failure, hepatic failure, active cancer).

  • Impairments that affect metabolism of the medication including: Severe renalimpairment (Creatinine clearance equal to or greater than 9), and moderate or severehepatic impairment (Child-Pugh score >7)

  • Patients using medications that have major effects on brain neurotransmitter systemsor cognition within 2 months of enrollment. Exclusionary medications are: medicationswith significant anti-cholinergic activity (tricyclic antidepressants,diphenhydramine), anti-Parkinsonian medications (including Sinemet, amantadine,bromocriptine, pergolide, selegiline), and narcotic analgesics (> 2 doses per week).

Study Design

Total Participants: 8
Study Start date:
October 01, 2004
Estimated Completion Date:
December 31, 2007