Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01129479
First received: May 21, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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 Intervention
Aphasia
Stroke
Drug: Galantamine
Drug: Placebo pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Spontaneous Speech [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
    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:
  • ADP [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
    Aphasia Diagnostic Profile: lexical Retrieval, phrase length, phonemic fluency, and category fluency.

  • Communication Log scores [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
    Subject communication change log scores Caregiver communication change log score


Enrollment: 8
Study Start Date: October 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01129479

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

No publications provided

Responsible Party: Heidi Roth, University of North Carolina
ClinicalTrials.gov Identifier: NCT01129479     History of Changes
Other Study ID Numbers: GAL-EMR-4008
Study First Received: May 21, 2010
Last Updated: May 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Aphasia
treatment
cholinesterase inhibitor
stroke

Additional relevant MeSH terms:
Aphasia
Aphasia, Broca
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Communication Disorders
Language Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Speech Disorders
Vascular Diseases
Galantamine
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Parasympathomimetics
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 21, 2014