Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

NCT ID: NCT01129479

Last Updated: 2010-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2007-12-31

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.

Conditions

Aphasia; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Galantamine

Group Type: ACTIVE_COMPARATOR

Galantamine

Intervention Type: 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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo pill

Intervention Type: DRUG

Placebo pill each morning with food for 12 weeks.

Interventions

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.

Intervention Type: DRUG

Placebo pill

Placebo pill each morning with food for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Razadyne; Reminyl

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho-McNeil Neurologics, Inc.

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

University of North Carolina

Principal Investigators

Heidi L Roth, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Other Identifiers

GAL-EMR-4008

Identifier Type: -

Identifier Source: org_study_id