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Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease

NCT ID: NCT00096720

Last Updated: 2010-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson Disease Parkinsonian Syndrome

Keywords

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parkinson brain imaging diagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Interventions

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levodopa

Intervention Type DRUG

Mirapex (pramipexole)

Intervention Type DRUG

[123I]ß-CIT and SPECT imaging

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

United States Department of Defense

FED

Sponsor Role collaborator

Institute for Neurodegenerative Disorders

OTHER

Sponsor Role lead

Responsible Party

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Institute for Neurodegenerative Disorders

Principal Investigators

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Danna Jennings, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Neurodegenerative Disorders

Locations

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Pacific Neuroscience Medical Group

Oxnard, California, United States

Site Status

Colorado Neurology, PC

Englewood, Colorado, United States

Site Status

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Site Status

University of Florida Movement Disorders Center

Gainesville, Florida, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

RUSH University Medical Center

Chicago, Illinois, United States

Site Status

Boston University Medical Center

Boston, Massachusetts, United States

Site Status

Lahey Clinic Medical Center

Burlington, Massachusetts, United States

Site Status

Parkinson's Disease and Movement Disorders Center of Albany Medical College

Albany, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

NeuroHealth, Inc.

Warwick, Rhode Island, United States

Site Status

University of Tennessee Health Science Center

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12580184 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10584667 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9120429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8959987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11402115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8265656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10348466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9117410 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11739831 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9527140 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11083235 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11926889 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16222436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9087972 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12464116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12838524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12578913 (View on PubMed)

Other Identifiers

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INSPECT

Identifier Type: -

Identifier Source: org_study_id