Does Galantamine Facilitate Recovery from Non-Fluent Aphasia After Ischemic Stroke?

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1 The treatment of aphasia is predicted to become more biological than behavioral, where aphasia is not just controlled but cured. Presently speech-language pathologists and others concerned with treating aphasia are limited by The poor understanding of the subacute physiological changes in the brain after stroke; The emphasis on treating language functions instead of brain functions; The inability to bring about rapid behavioral changes for the patient with treatment. 1 A pilot study was recently completed on the use of the drug galantamine (trade name RAZADYNE), to accelerate language return after stroke with non-fluent aphasia. Galantamine is currently approved for treatment of cognitive impairment in mild/moderate dementia. A Pilot Study of the effect of an Acetylcholinesterase Inhibitor (Galantamine) on 1

2 Ten persons completed the study over a 17-week period. The study is characterized as: Randomized; Double-blinded; Placebo-controlled; Pilot; Galantamine was selected for its propensity to inhibit acetylcholinesterase, possibly facilitating cognitive activity. Acetylcholine facilitating aphasia recovery has been rarely reported in contemporary aphasia research; activation of norepinephrine and dopamine receptors through drug trials predominates in the literature 2. Given the study protocol, persons with nonfluent aphasia (impaired length of utterance and impaired fluency) completed the following test battery: National Institutes of Health Stroke Scale; Barthel Index; Boston Diagnostic Aphasia Examination; Porch Index of Communicative Ability; Quality of Communication Life Scale. A Pilot Study of the effect of an Acetylcholinesterase Inhibitor (Galantamine) on 2

3 Study participants were assessed at baseline and again at week 13 and week 17. All participants participated in speech-language therapy during part, or all, of their enrollment in the protocol. Demographics on the study participants follow below. Mean age 73 years Gender Female, 70%; Male, 30% Race 80% African-American Stroke sites of lesion L frontoparietal = 5; L parietooccipital = 3; L basal ganglia = 1; L caudate = 1 Stroke etiologies Atrial fibrillation; hypertension; carotid stenosis Mean study enrollment 23 days post onset date Mean week days post onset assessment date Results for all participants in the study protocol are contained in the following table. A Pilot Study of the effect of an Acetylcholinesterase Inhibitor (Galantamine) on 3

4 Placebo (n=4) Mean ± SE Galantamine (n=6) Mean ± SE P-value Days after onset, n NIHSS score Gain 17.3 ± ± ± ± ± ± ± ± ± ± PICA percentile score * Gain 15.0 ± ± ± ± ± ± ± ± ± ± Achieved PICA 15 percentile point change at week 13, 17 BI score Gain QCL score + Gain 1/4 (25%) 4/6 (66%) ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± National Institute of Health Stroke Scale: 0 (low) to 42 (high) severity of stroke *Porch Index of Communicative Ability percentile score: aphasia severity -- 1 (severe) to 99 (normal) Barthel Index: 0 (low) to 100 (high) functional capacity +Quality of Communication Life: 1 (low) to 5 (high) quality of life Fisher exact test n=3 as one participant unable to complete QCL A Pilot Study of the effect of an Acetylcholinesterase Inhibitor (Galantamine) on 4

5 Results of this study suggest there is insufficient evidence at present, for galantamine to be used to hasten improvements in language function following nonfluent aphasia. Larger randomized controlled trials will be required to answer research questions such as those posed here. Nevertheless, this study does affirm findings of previous research into the pharmacotherapy for aphasia that return of language function is best observed in patients given both behavioral and drug treatments. BIBLIOGRAPHY 1 Wineburgh, L. F., & Small, S. L. (2004, April 27). Aphasia treatment and the crossroads: A biological perspective. The ASHA Leader, pp. 6-7, Walker-Batson, Delaina, Use of Pharmacotherapy to Improve Functional Outcome in Stroke, Miami, FL: paper to be delivered to the American Speech-Language-Hearing Association convention; 11/16/2006. A Pilot Study of the effect of an Acetylcholinesterase Inhibitor (Galantamine) on 5