Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-01 @ 9:54 PM
Study NCT ID:
NCT00096720
Status:
COMPLETED
Last Update Posted:
2010-09-29
First Post:
2004-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007980', 'term': 'Levodopa'}, {'id': 'D000077487', 'term': 'Pramipexole'}], 'ancestors': [{'id': 'D004295', 'term': 'Dihydroxyphenylalanine'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D052160', 'term': 'Benzothiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-28', 'studyFirstSubmitDate': '2004-11-12', 'studyFirstSubmitQcDate': '2004-11-12', 'lastUpdatePostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in outcomes from scan 1 to scan 2'}], 'secondaryOutcomes': [{'measure': 'Change in outcomes from scan 2 to scan 3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['parkinson', 'brain imaging', 'diagnosis'], 'conditions': ['Parkinson Disease', 'Parkinsonian Syndrome']}, 'referencesModule': {'references': [{'pmid': '12580184', 'type': 'BACKGROUND', 'citation': "Ahlskog JE. Slowing Parkinson's disease progression: recent dopamine agonist trials. Neurology. 2003 Feb 11;60(3):381-9. doi: 10.1212/01.wnl.0000044047.58984.2f."}, {'pmid': '10584667', 'type': 'BACKGROUND', 'citation': "Ahlskog JE, Uitti RJ, O'Connor MK, Maraganore DM, Matsumoto JY, Stark KF, Turk MF, Burnett OL. The effect of dopamine agonist therapy on dopamine transporter imaging in Parkinson's disease. Mov Disord. 1999 Nov;14(6):940-6. doi: 10.1002/1531-8257(199911)14:63.0.co;2-y."}, {'pmid': '9120429', 'type': 'BACKGROUND', 'citation': "Brucke T, Asenbaum S, Pirker W, Djamshidian S, Wenger S, Wober C, Muller C, Podreka I. Measurement of the dopaminergic degeneration in Parkinson's disease with [123I] beta-CIT and SPECT. Correlation with clinical findings and comparison with multiple system atrophy and progressive supranuclear palsy. J Neural Transm Suppl. 1997;50:9-24."}, {'pmid': '8959987', 'type': 'BACKGROUND', 'citation': 'Fahn S. Is levodopa toxic? Neurology. 1996 Dec;47(6 Suppl 3):S184-95. doi: 10.1212/wnl.47.6_suppl_3.184s. No abstract available.'}, {'pmid': '11402115', 'type': 'BACKGROUND', 'citation': 'Guttman M, Stewart D, Hussey D, Wilson A, Houle S, Kish S. Influence of L-dopa and pramipexole on striatal dopamine transporter in early PD. Neurology. 2001 Jun 12;56(11):1559-64. doi: 10.1212/wnl.56.11.1559.'}, {'pmid': '8265656', 'type': 'BACKGROUND', 'citation': 'Innis RB, Seibyl JP, Scanley BE, Laruelle M, Abi-Dargham A, Wallace E, Baldwin RM, Zea-Ponce Y, Zoghbi S, Wang S, et al. Single photon emission computed tomographic imaging demonstrates loss of striatal dopamine transporters in Parkinson disease. Proc Natl Acad Sci U S A. 1993 Dec 15;90(24):11965-9. doi: 10.1073/pnas.90.24.11965.'}, {'pmid': '10348466', 'type': 'BACKGROUND', 'citation': 'Innis RB, Marek KL, Sheff K, Zoghbi S, Castronuovo J, Feigin A, Seibyl JP. Effect of treatment with L-dopa/carbidopa or L-selegiline on striatal dopamine transporter SPECT imaging with [123I]beta-CIT. Mov Disord. 1999 May;14(3):436-42. doi: 10.1002/1531-8257(199905)14:33.0.co;2-j.'}, {'pmid': '9117410', 'type': 'BACKGROUND', 'citation': 'Little KY, Gorebig J, Carroll FI, Mapili J, Meador-Woodruff JH. Lack of dopamine receptor agonists effect on striatal dopamine transporter binding sites. Brain Res. 1996 Dec 2;742(1-2):313-6. doi: 10.1016/s0006-8993(96)01033-5.'}, {'pmid': '11739831', 'type': 'BACKGROUND', 'citation': "Marek K, Innis R, van Dyck C, Fussell B, Early M, Eberly S, Oakes D, Seibyl J. [123I]beta-CIT SPECT imaging assessment of the rate of Parkinson's disease progression. Neurology. 2001 Dec 11;57(11):2089-94. doi: 10.1212/wnl.57.11.2089."}, {'pmid': '9527140', 'type': 'BACKGROUND', 'citation': "Morrish PK, Rakshi JS, Bailey DL, Sawle GV, Brooks DJ. Measuring the rate of progression and estimating the preclinical period of Parkinson's disease with [18F]dopa PET. J Neurol Neurosurg Psychiatry. 1998 Mar;64(3):314-9. doi: 10.1136/jnnp.64.3.314."}, {'pmid': '11083235', 'type': 'BACKGROUND', 'citation': 'Nurmi E, Bergman J, Eskola O, Solin O, Hinkka SM, Sonninen P, Rinne JO. Reproducibility and effect of levodopa on dopamine transporter function measurements: a [18F]CFT PET study. J Cereb Blood Flow Metab. 2000 Nov;20(11):1604-9. doi: 10.1097/00004647-200011000-00010.'}, {'pmid': '11926889', 'type': 'BACKGROUND', 'citation': 'Parkinson Study Group. Dopamine transporter brain imaging to assess the effects of pramipexole vs levodopa on Parkinson disease progression. JAMA. 2002 Apr 3;287(13):1653-61. doi: 10.1001/jama.287.13.1653.'}, {'pmid': '16222436', 'type': 'BACKGROUND', 'citation': "Fahn S; Parkinson Study Group. Does levodopa slow or hasten the rate of progression of Parkinson's disease? J Neurol. 2005 Oct;252 Suppl 4:IV37-IV42. doi: 10.1007/s00415-005-4008-5."}, {'pmid': '9087972', 'type': 'BACKGROUND', 'citation': 'Rioux L, Frohna PA, Joyce JN, Schneider JS. The effects of chronic levodopa treatment on pre- and postsynaptic markers of dopaminergic function in striatum of parkinsonian monkeys. Mov Disord. 1997 Mar;12(2):148-58. doi: 10.1002/mds.870120204.'}, {'pmid': '12464116', 'type': 'BACKGROUND', 'citation': "Schapira AH. Dopamine agonists and neuroprotection in Parkinson's disease. Eur J Neurol. 2002 Nov;9 Suppl 3:7-14. doi: 10.1046/j.1468-1331.9.s3.9.x."}, {'pmid': '12838524', 'type': 'BACKGROUND', 'citation': "Whone AL, Watts RL, Stoessl AJ, Davis M, Reske S, Nahmias C, Lang AE, Rascol O, Ribeiro MJ, Remy P, Poewe WH, Hauser RA, Brooks DJ; REAL-PET Study Group. Slower progression of Parkinson's disease with ropinirole versus levodopa: The REAL-PET study. Ann Neurol. 2003 Jul;54(1):93-101. doi: 10.1002/ana.10609."}, {'pmid': '12578913', 'type': 'BACKGROUND', 'citation': 'Wooten GF. Agonists vs levodopa in PD: the thrilla of whitha. Neurology. 2003 Feb 11;60(3):360-2. doi: 10.1212/wnl.60.3.360. No abstract available.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 30 years or older at time of Parkinson Disease (PD) diagnosis\n* clinical diagnosis of PD of equal to or less than 7.5 years\n* Normal laboratory screening\n\nExclusion Criteria:\n\n* Participant is pregnant\n* Participant has atypical or drug induced PD\n* Participant has significant dementia'}, 'identificationModule': {'nctId': 'NCT00096720', 'briefTitle': "Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Institute for Neurodegenerative Disorders'}, 'officialTitle': "Investigating Effects of Short-term Treatment With Pramipexole or Levodopa on [123I]B-CIT and SPECT Imaging in Early Parkinson's", 'orgStudyIdInfo': {'id': 'INSPECT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'levodopa', 'type': 'DRUG'}, {'name': 'Mirapex (pramipexole)', 'type': 'DRUG'}, {'name': '[123I]ß-CIT and SPECT imaging', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93030', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Neuroscience Medical Group', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Neurology, PC', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Institute for Neurodegenerative Disorders', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Movement Disorders Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'RUSH University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '12205', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': "Parkinson's Disease and Movement Disorders Center of Albany Medical College", 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'NeuroHealth, Inc.', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Health Science Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Danna Jennings, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Neurodegenerative Disorders'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Neurodegenerative Disorders', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, {'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'oldNameTitle': 'Danna Jennings M.D.', 'oldOrganization': 'Institute for Neurodegenerative Disorders'}}}}