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Galantamine Executive Function in Parkinson's Disease
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Memorial Hospital of Rhode Island
Ortho-McNeil Neurologics, Inc.
Information provided by: Memorial Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT00211588
  Purpose

The aim of the study is to determine whether galantamine stabilizes or improves thinking abilities in individuals with Parkinson's disease. Individuals included in the study have minor complaints about thinking such as problems with concentration or memory but do not have dementia. This medication has been shown to have a positive effect on stabilizing memory in individuals with Alzheimer's disease. It is FDA approved for use in elderly individuals with Alzheimer's disease. It is hypothesized that galantamine will stabilize or improve executive and attentional functions in individuals with Parkinson's.


Condition Intervention
Parkinson's Disease
Drug: galantamine

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Galantamine hydrobromide Galantamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Investigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's Disease

Further study details as provided by Memorial Hospital of Rhode Island:

Primary Outcome Measures:
  • Improvement on cognitive measures [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • No worsening of PD symptoms [ Time Frame: 16 weeks ]

Estimated Enrollment: 90
Study Start Date: June 2004
Estimated Study Completion Date: May 2007
Detailed Description:

While several cholinesterase inhibitors have effectiveness in Alzheimer's disease (AD), galantamine is unique since it has a dual mode of action: inhibition of acetylcholinesterase and modulation of nicotinic acetylcholine receptors.As Parkinson's disease (PD) impacts frontal systems, executive cognition rather than memory function (mediated by medial temporal) would be the targeted area for potential improvement. This single center, double blind, placebo controlled study compares a group of PD patients treated with galantamine to a group of PD patients who are not treated with this medication on a series of cognitive tasks that examine attention and executive control.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's Disease

Exclusion Criteria:

  • dementia, depression, cardiac disease, gastrointestinal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211588

Locations
United States, Rhode Island
Memorial Hospital of RI
Pawtucket, Rhode Island, United States, 02860
Sponsors and Collaborators
Memorial Hospital of Rhode Island
Ortho-McNeil Neurologics, Inc.
Investigators
Principal Investigator: Joseph H Friedman, M.D. NeuroHealth
Study Director: Janet Grace, Ph.D. Memorial Hospital of RI
  More Information

Study ID Numbers: GAL-EMR-4022
Study First Received: September 13, 2005
Last Updated: May 4, 2007
ClinicalTrials.gov Identifier: NCT00211588  
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Hospital of Rhode Island:
cognition

Study placed in the following topic categories:
Ganglion Cysts
Galantamine
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
Parasympathomimetics
Nootropic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Cholinergic Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009