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Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01129479
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : May 24, 2010
Ortho-McNeil Neurologics, Inc.
Information provided by:
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Aphasia Stroke Drug: Galantamine Drug: Placebo pill Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Galantamine Treatment for Nonfluent Aphasia in Stroke Patients
Study Start Date : October 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Active Comparator: Galantamine Drug: Galantamine
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 Comparator: Placebo Drug: Placebo pill
Placebo pill each morning with food for 12 weeks.

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01129479

Sponsors and Collaborators
University of North Carolina, Chapel Hill
Ortho-McNeil Neurologics, Inc.
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Principal Investigator: Heidi L Roth, MD University of North Carolina

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Responsible Party: Heidi Roth, University of North Carolina Identifier: NCT01129479    
Other Study ID Numbers: GAL-EMR-4008
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: May 24, 2010
Last Verified: May 2010
Keywords provided by University of North Carolina, Chapel Hill:
cholinesterase inhibitor
Additional relevant MeSH terms:
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Aphasia, Broca
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents