Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

Stroke Clinical Trial

Official title:

Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129479
• Other study ID #: GAL-EMR-4008
• Status: Completed
• Phase: N/A
• First received: May 21, 2010
• Last updated: May 21, 2010
• Start date: October 2004
• Est. completion date: December 2007

Study information

• Verified date: May 2010
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Broca
• Stroke

Intervention

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.
• Placebo pill
Placebo pill each morning with food for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Ortho-McNeil Neurologics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Every 4 weeks	No
Secondary	ADP	Aphasia Diagnostic Profile: lexical Retrieval, phrase length, phonemic fluency, and category fluency.	Every 4 weeks	No
Secondary	Communication Log scores	Subject communication change log scores Caregiver communication change log score	Every 12 weeks	No