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Galantamine Executive Function in Parkinson's Disease
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by Memorial Hospital of Rhode Island.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Memorial Hospital of Rhode Island
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Memorial Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT00211588
First received: September 13, 2005
Last updated: May 4, 2007
Last verified: May 2007
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
U.S. FDA Resources
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 |
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 (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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00211588
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
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 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 4, 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 |
ClinicalTrials.gov processed this record on June 27, 2017