Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease

NCT00129181 | Completed

• 1 other identifier: AMAD001
• Study Type: interventional
• Target: 30
• Locations: 4 countries
• Sites: 9

Brief Summary

This study investigates whether there is a change in 123iodine-2ß- carbomethoxy-3ß-(4-iodophenyl) tropane (\[123I\]ß-CIT) uptake after short-term treatment with levodopa compared to either dopamine agonist or placebo.

Conditions

Parkinson Disease; Parkinsonian Syndrome

Keywords

parkinson; brain imaging; diagnosis

Outcome Measures

Primary Outcomes (1)

• To determine the influence of short-term levodopa therapy on dopamine transporter density in early Parkinson's disease

  1 year

Secondary Outcomes (2)

• To determine the influence of short-term treatment with cabergoline on dopamine transporter density in early Parkinson's disease

  1 year

• To further develop the AMADEUS consortium, a collaboration of clinical-imaging SPECT DAT sites able to obtain data using comparable techniques and transmit imaging to a central analysis site

  2 years

Interventions

cabergoline DRUG

Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).

carbidopa/levodopa DRUG

Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).

DATscan and SPECT imaging PROCEDURE

Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is aged 40 years or older.
• Written informed consent is obtained.
• Subjects have a clinical diagnosis of idiopathic Parkinson's disease.
• Hoehn and Yahr stages for subjects are I-II.

You may not qualify if:

• The subject has atypical or drug-induced Parkinson's disease.
• The subject has dementia.
• The subject has clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
• The subject is pregnant.

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead
• Pfizer: collaborator
• GE Healthcare: collaborator

Study Sites (9)

Department of Neurology, Innsbruck Medical University

Innsbruck, 6020, Austria

Location

Neurological Department, Wilhelminenspital

Vienna, 1160, Austria

Location

Dept. of Neurology, University of Leipzig

Leipzig, 04103, Germany

Location

Dept. of Neurology Marburg, Phillips-Univ.

Marburg, 35039, Germany

Location

Ambulanz für Bewegungsstörungen, Neurologische Poliklinik

München, 81377, Germany

Location

University of Catania-Department of Neurosciences

Catania, 95123, Italy

Location

Parkinson Institute Milan

Milan, Italy

Location

Department of Neurological Sciences-University of Napoli

Naples, 80131, Italy

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Related Publications (17)

• 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: 12580184 BACKGROUND

• 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: 10584667 BACKGROUND

• 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: 9120429 BACKGROUND

• 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: 8959987 BACKGROUND

• 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: 11402115 BACKGROUND

• 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: 8265656 BACKGROUND

• 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: 10348466 BACKGROUND

• 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: 9117410 BACKGROUND

• 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: 11739831 BACKGROUND

• 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: 9527140 BACKGROUND

• 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: 11083235 BACKGROUND

• 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: 11926889 BACKGROUND

• 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: 16222436 BACKGROUND

• 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: 9087972 BACKGROUND

• 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: 12464116 BACKGROUND

• 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: 12838524 BACKGROUND

• 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.

  PMID: 12578913 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Disease

Interventions

Cabergoline; carbidopa, levodopa drug combination; ioflupane

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kenneth L Marek, MD

  The Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

• John P Seibyl, MD

  The Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2005
• First Posted: August 11, 2005
• Study Start: January 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: January 1, 2007
• Last Updated: August 28, 2009

Record last verified: 2009-08

Locations

DE (3); AU (2); IT (3); ES (1)