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OpenTrials
Completed

NCT Number: NCT01129479

Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

  • Patients receiving ongoing individual speech therapy. (Most patients are no longer eligible for individualized speech therapy after 6 months from stroke onset, thus this should not eliminate many patients).
  • Extremely mild or extremely severe aphasia. (Boston Naming Test Score <3 or >45 items named from 60 items).
  • Global dementia (and any other patient with reduced decisional capacity requiring a legally authorized representative for consent).
  • Presence of major cognitive deficit other than aphasia caused by stroke related disease.
  • Contraindications to cholinomimetic agents: History of active peptic ulcer disease within 1 year, Severe asthma, unstable angina, bradyarrhythmia with resting pulse less than 50, sick sinus syndrome, or seizures.
  • Major psychiatric disorders that affect cognition including: psychosis, major depression, bipolar disorder, alcohol or substance abuse.
  • Major medical conditions that alter cognition (e.g., heart failure, dialysis dependent renal failure, hepatic failure, active cancer).
  • Impairments that affect metabolism of the medication including: Severe renal impairment (Creatinine clearance equal to or greater than 9), and moderate or severe hepatic impairment (Child-Pugh score >7)
  • Patients using medications that have major effects on brain neurotransmitter systems or cognition within 2 months of enrollment. Exclusionary medications are: medications with significant anti-cholinergic activity (tricyclic antidepressants, diphenhydramine), anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegiline), and narcotic analgesics (> 2 doses per week).

Treatment and study plan

Galantamine

Drug

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.

Other names: Razadyne, Reminyl

Placebo pill

Drug

Placebo pill each morning with food for 12 weeks.

Primary outcomes

  1. 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.

Secondary outcomes

  1. ADP

    Time frame: Every 4 weeks

    Aphasia Diagnostic Profile: lexical Retrieval, phrase length, phonemic fluency, and category fluency.

  2. Communication Log scores

    Time frame: Every 12 weeks

    Subject communication change log scores Caregiver communication change log score

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Ortho-McNeil Neurologics, Inc.

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
May 24, 2010
Registry last updated
May 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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