Back to resultsGalantamine Treatment for Nonfluent Aphasia in Stroke Patients
Primary Purpose
Aphasia, Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Galantamine
Placebo pill
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring Aphasia, treatment, cholinesterase inhibitor, stroke
Eligibility 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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Galantamine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Spontaneous Speech
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
Aphasia Diagnostic Profile: lexical Retrieval, phrase length, phonemic fluency, and category fluency.
Communication Log scores
Subject communication change log scores Caregiver communication change log score
Full Information
NCT ID
NCT01129479
First Posted
May 21, 2010
Last Updated
May 21, 2010
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Ortho-McNeil Neurologics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01129479
Brief Title
Galantamine Treatment for Nonfluent Aphasia in Stroke Patients
Official Title
Galantamine Treatment for Nonfluent Aphasia in Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Ortho-McNeil Neurologics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
Keywords
Aphasia, treatment, cholinesterase inhibitor, stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Galantamine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Galantamine
Other Intervention Name(s)
Razadyne, Reminyl
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo pill
Intervention Description
Placebo pill each morning with food for 12 weeks.
Primary Outcome Measure Information:
Title
Spontaneous Speech
Description
Analysis of spontaneous speech production with picture description (cookie theft picture): content units and lexical efficiency; as well as Boston Naming Test naming latency.
Time Frame
Every 4 weeks
Secondary Outcome Measure Information:
Title
ADP
Description
Aphasia Diagnostic Profile: lexical Retrieval, phrase length, phonemic fluency, and category fluency.
Time Frame
Every 4 weeks
Title
Communication Log scores
Description
Subject communication change log scores Caregiver communication change log score
Time Frame
Every 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi L Roth, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Galantamine Treatment for Nonfluent Aphasia in Stroke Patients
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