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Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

NCT01129479 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2010-05-24

No results posted yet for this study

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

Interventions

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.

DRUG

Placebo pill

Placebo pill each morning with food for 12 weeks.

Sponsors & Collaborators

  • Ortho-McNeil Neurologics, Inc.

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Heidi L Roth, MD · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2007-12-31
Completion
2007-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01129479 on ClinicalTrials.gov