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Galantamine Executive Function in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00211588
Recruitment Status : Unknown
Verified May 2007 by Memorial Hospital of Rhode Island.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : May 7, 2007
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Memorial Hospital of Rhode Island

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson's Disease Drug: galantamine Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Investigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's Disease
Study Start Date : June 2004
Estimated Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's Disease

Exclusion Criteria:

  • dementia, depression, cardiac disease, gastrointestinal disease
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00211588     History of Changes
Other Study ID Numbers: GAL-EMR-4022
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 7, 2007
Last Verified: May 2007

Keywords provided by Memorial Hospital of Rhode Island:
cognition

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Galantamine
Cholinesterase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents