Galantamine Treatment for Nonfluent Aphasia in Stroke Patients

NCT01129479 | Completed

• 1 other identifier: GAL-EMR-4008
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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

Keywords

Aphasia; treatment; cholinesterase inhibitor; stroke

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• ADP

  Every 4 weeks

• Communication Log scores

  Every 12 weeks

Study Arms (2)

Galantamine

ACTIVE COMPARATOR

Drug: Galantamine

Placebo

PLACEBO COMPARATOR

Drug: Placebo pill

Interventions

Galantamine 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.

Also known as: Razadyne, Reminyl

Galantamine

Placebo pill DRUG

Placebo pill each morning with food for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Ortho-McNeil Neurologics, Inc.: collaborator

MeSH Terms

Conditions

Aphasia; Stroke

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Heidi L Roth, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: May 24, 2010
• Study Start: October 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 24, 2010

Record last verified: 2010-05