Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease
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Purpose
Study participants who have been clinically diagnosed with Parkinson disease will receive no treatment, treatment with either levodopa, or treatment with Mirapex for a period of 12 weeks. Over the course of the study subjects will travel to the Institute for Neurodegenerative Disorders (IND) in New Haven, Connecticut for brain imaging.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease Parkinsonian Syndrome |
Drug: levodopa Drug: Mirapex (pramipexole) Procedure: [123I]ß-CIT and SPECT imaging |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Diagnostic |
| Official Title: | Investigating Effects of Short-term Treatment With Pramipexole or Levodopa on [123I]B-CIT and SPECT Imaging in Early Parkinson's |
- Change in outcomes from scan 1 to scan 2
- Change in outcomes from scan 2 to scan 3
| Enrollment: | 112 |
| Study Start Date: | February 2004 |
| Study Completion Date: | May 2007 |
Brain imaging will be conducted three times during this study. Study participants will travel to IND for [123I]ß-CIT and SPECT imaging (scan 1). Subjects will be randomized to no treatment, treatment with either levodopa, or treatment with Mirapex and undergo treatment for a period of 12 weeks. Subjects will return to IND for [123I]ß-CIT and SPECT imaging (scan 2) after 12 weeks of treatment and withdraw from the medication following the scan. Eight to 12 weeks after medication withdrawal, a final [123I]ß-CIT and SPECT imaging study (scan 3) will be performed at IND. The imaging outcome, striatal uptake of [123I]ß-CIT, from scan 1 (untreated) and scan 2 (treated with levodopa or pramipexole) will be compared to determine if there is a significant change in the uptake of the marker that may be attributed to levodopa or pramipexole treatment. In addition, scan 3 will be compared to scan 2 to determine the duration and reversibility of any regulatory effect that occurs. The subjects will be randomized, but not blinded to study drug assignment. The imaging technologist and all imaging analyses will be performed by investigators blinded to study drug assignment.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 30 years or older at time of Parkinson Disease (PD) diagnosis
- clinical diagnosis of PD of equal to or less than 7.5 years
- Normal laboratory screening
Exclusion Criteria:
- Participant is pregnant
- Participant has atypical or drug induced PD
- Participant has significant dementia
Contacts and Locations| United States, California | |
| Pacific Neuroscience Medical Group | |
| Oxnard, California, United States, 93030 | |
| United States, Colorado | |
| Colorado Neurology, PC | |
| Englewood, Colorado, United States, 80113 | |
| United States, Connecticut | |
| Institute for Neurodegenerative Disorders | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| University of Florida Movement Disorders Center | |
| Gainesville, Florida, United States, 32610 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| RUSH University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Massachusetts | |
| Boston University Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Lahey Clinic Medical Center | |
| Burlington, Massachusetts, United States, 01805 | |
| United States, New York | |
| Parkinson's Disease and Movement Disorders Center of Albany Medical College | |
| Albany, New York, United States, 12205 | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27705 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Rhode Island | |
| NeuroHealth, Inc. | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, Tennessee | |
| University of Tennessee Health Science Center | |
| Memphis, Tennessee, United States, 38163 | |
| Principal Investigator: | Danna Jennings, MD | Institute for Neurodegenerative Disorders |
More Information
Publications:
| Responsible Party: | Danna Jennings M.D., Institute for Neurodegenerative Disorders |
| ClinicalTrials.gov Identifier: | NCT00096720 History of Changes |
| Other Study ID Numbers: | INSPECT |
| Study First Received: | November 12, 2004 |
| Last Updated: | September 28, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Institute for Neurodegenerative Disorders:
|
parkinson brain imaging diagnosis |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Levodopa Pramipexol Antiparkinson Agents |
Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antioxidants Protective Agents Dopamine Agonists |
ClinicalTrials.gov processed this record on June 17, 2013