Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Galantamine (Reminyl┬«)Drug
    Other Names: Razadyne
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Galantamine
  • Placebo pill Drug
    Intervention Desc: Placebo pill each morning with food for 12 weeks.
    ARM 1: Kind: Experimental
    Label: Placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Spontaneous Speech Every 4 weeks No
Secondary ADP Every 4 weeks No
Secondary Communication Log scores Every 12 weeks No

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