Galantamine Executive Function in Parkinson's Disease
Recruitment status was Active, not recruiting
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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 Endpoint Classification: Safety/Efficacy Study 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 |
- Improvement on cognitive measures [ Time Frame: 16 weeks ]
- 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Idiopathic Parkinson's Disease
Exclusion Criteria:
- dementia, depression, cardiac disease, gastrointestinal disease
Contacts and Locations| United States, Rhode Island | |
| Memorial Hospital of RI | |
| Pawtucket, Rhode Island, United States, 02860 | |
| Principal Investigator: | Joseph H Friedman, M.D. | NeuroHealth |
| Study Director: | Janet Grace, Ph.D. | Memorial Hospital of RI |
More Information
No publications provided
| 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 |
| Health Authority: | United States: Food and Drug Administration |
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 Parasympathomimetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nootropic Agents Central Nervous System Agents Therapeutic Uses Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on June 18, 2013