NCT00354003

Brief Summary

The overall goal of the study is to evaluate how research participants in Parkinson Disease studies that include brain imaging with a dopamine transporter ligand choose to receive the imaging data and what is the impact of the imaging data information on the management of their symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

July 17, 2006

Last Update Submit

April 1, 2019

Conditions

Parkinsonian SyndromeParkinson

Keywords

ParkinsonImaging

Interventions

A series of questionnairesBEHAVIORAL

Research participants who previously underwent ß-CIT imaging will be contacted by the staff at IND to enquire whether they would like to receive their ß-CIT scan data. After signing a Research Participant Information and Consent Form, all research participants will be asked to complete a questionnaire prior to receipt of their imaging data. Those research participants requesting imaging data will be sent their data by IND and may review their data with IND (by phone) and/ or with their study investigator. All research participants will be asked to respond to a second questionnaire after receiving their imaging data and to a third study questionnaire approximately six weeks following receipt of their imaging data.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Research participants who previously underwent ß-CIT imaging

You may qualify if:

  • Previous participation in imaging study as described within the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Related Publications (21)

  • Asenbaum S, Brucke T, Pirker W, Podreka I, Angelberger P, Wenger S, Wober C, Muller C, Deecke L. Imaging of dopamine transporters with iodine-123-beta-CIT and SPECT in Parkinson's disease. J Nucl Med. 1997 Jan;38(1):1-6.

    PMID: 8998140BACKGROUND

  • Mozley PD, Schneider JS, Acton PD, Plossl K, Stern MB, Siderowf A, Leopold NA, Li PY, Alavi A, Kung HF. Binding of [99mTc]TRODAT-1 to dopamine transporters in patients with Parkinson's disease and in healthy volunteers. J Nucl Med. 2000 Apr;41(4):584-9.

    PMID: 10768556BACKGROUND

  • Booij J, Habraken JB, Bergmans P, Tissingh G, Winogrodzka A, Wolters EC, Janssen AG, Stoof JC, van Royen EA. Imaging of dopamine transporters with iodine-123-FP-CIT SPECT in healthy controls and patients with Parkinson's disease. J Nucl Med. 1998 Nov;39(11):1879-84.

    PMID: 9829575BACKGROUND

  • 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: 8265656BACKGROUND

  • Kaufman MJ, Madras BK. Severe depletion of cocaine recognition sites associated with the dopamine transporter in Parkinson's-diseased striatum. Synapse. 1991 Sep;9(1):43-9. doi: 10.1002/syn.890090107.

    PMID: 1796351BACKGROUND

  • Niznik HB, Fogel EF, Fassos FF, Seeman P. The dopamine transporter is absent in parkinsonian putamen and reduced in the caudate nucleus. J Neurochem. 1991 Jan;56(1):192-8. doi: 10.1111/j.1471-4159.1991.tb02580.x.

    PMID: 1987318BACKGROUND

  • Wilson JM, Levey AI, Rajput A, Ang L, Guttman M, Shannak K, Niznik HB, Hornykiewicz O, Pifl C, Kish SJ. Differential changes in neurochemical markers of striatal dopamine nerve terminals in idiopathic Parkinson's disease. Neurology. 1996 Sep;47(3):718-26. doi: 10.1212/wnl.47.3.718.

    PMID: 8797470BACKGROUND

  • Huang WS, Lin SZ, Lin JC, Wey SP, Ting G, Liu RS. Evaluation of early-stage Parkinson's disease with 99mTc-TRODAT-1 imaging. J Nucl Med. 2001 Sep;42(9):1303-8.

    PMID: 11535717BACKGROUND

  • Booij J, Tissingh G, Boer GJ, Speelman JD, Stoof JC, Janssen AG, Wolters EC, van Royen EA. [123I]FP-CIT SPECT shows a pronounced decline of striatal dopamine transporter labelling in early and advanced Parkinson's disease. J Neurol Neurosurg Psychiatry. 1997 Feb;62(2):133-40. doi: 10.1136/jnnp.62.2.133.

    PMID: 9048712BACKGROUND

  • Fischman AJ, Bonab AA, Babich JW, Palmer EP, Alpert NM, Elmaleh DR, Callahan RJ, Barrow SA, Graham W, Meltzer PC, Hanson RN, Madras BK. Rapid detection of Parkinson's disease by SPECT with altropane: a selective ligand for dopamine transporters. Synapse. 1998 Jun;29(2):128-41. doi: 10.1002/(SICI)1098-2396(199806)29:23.0.CO;2-9.

    PMID: 9593103BACKGROUND

  • Seibyl JP, Marek KL, Quinlan D, Sheff K, Zoghbi S, Zea-Ponce Y, Baldwin RM, Fussell B, Smith EO, Charney DS, van Dyck C, et al. Decreased single-photon emission computed tomographic [123I]beta-CIT striatal uptake correlates with symptom severity in Parkinson's disease. Ann Neurol. 1995 Oct;38(4):589-98. doi: 10.1002/ana.410380407.

    PMID: 7574455BACKGROUND

  • Volkow ND, Fowler JS, Wang GJ, Logan J, Schlyer D, MacGregor R, Hitzemann R, Wolf AP. Decreased dopamine transporters with age in health human subjects. Ann Neurol. 1994 Aug;36(2):237-9. doi: 10.1002/ana.410360218.

    PMID: 8053661BACKGROUND

  • van Dyck CH, Seibyl JP, Malison RT, Laruelle M, Zoghbi SS, Baldwin RM, Innis RB. Age-related decline in dopamine transporters: analysis of striatal subregions, nonlinear effects, and hemispheric asymmetries. Am J Geriatr Psychiatry. 2002 Jan-Feb;10(1):36-43.

    PMID: 11790633BACKGROUND

  • Khan NL, Brooks DJ, Pavese N, Sweeney MG, Wood NW, Lees AJ, Piccini P. Progression of nigrostriatal dysfunction in a parkin kindred: an [18F]dopa PET and clinical study. Brain. 2002 Oct;125(Pt 10):2248-56. doi: 10.1093/brain/awf237.

    PMID: 12244082BACKGROUND

  • Dekker M, Bonifati V, van Swieten J, Leenders N, Galjaard RJ, Snijders P, Horstink M, Heutink P, Oostra B, van Duijn C. Clinical features and neuroimaging of PARK7-linked parkinsonism. Mov Disord. 2003 Jul;18(7):751-7. doi: 10.1002/mds.10422.

    PMID: 12815653BACKGROUND

  • Mozley PD, Acton PD, Barraclough ED, Plossl K, Gur RC, Alavi A, Mathur A, Saffer J, Kung HF. Effects of age on dopamine transporters in healthy humans. J Nucl Med. 1999 Nov;40(11):1812-7.

    PMID: 10565775BACKGROUND

  • Catafau AM, Tolosa E; DaTSCAN Clinically Uncertain Parkinsonian Syndromes Study Group. Impact of dopamine transporter SPECT using 123I-Ioflupane on diagnosis and management of patients with clinically uncertain Parkinsonian syndromes. Mov Disord. 2004 Oct;19(10):1175-82. doi: 10.1002/mds.20112.

    PMID: 15390019BACKGROUND

  • Jennings DL, Seibyl JP, Oakes D, Eberly S, Murphy J, Marek K. (123I) beta-CIT and single-photon emission computed tomographic imaging vs clinical evaluation in Parkinsonian syndrome: unmasking an early diagnosis. Arch Neurol. 2004 Aug;61(8):1224-9. doi: 10.1001/archneur.61.8.1224.

    PMID: 15313838BACKGROUND

  • Whone, A., et al., The REAL-PET study: Slower progression in early Parkinson's disease treated with ropinirole compared with L-Dopa. Neurology, 2002. 58 (suppl3): p. A82-A83.

    BACKGROUND

  • Parkinson Study Group, Levodopa and the progression of Parkinson disease. NEMJ, 2004. 351: p. 18-28.

    BACKGROUND

  • Marek, K., J. Seibyl, and Parkinson Study Group, ß-CIT Scans without evidence of dopaminergic deficit (SWEDD) in the ELLDOPA-CIT and CALM-CIT study: long-term imaging assessment. Neurology, 2003. 60 (Suppl 1): p. A298.

    BACKGROUND

MeSH Terms

Conditions

Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement Disorders

Study Officials

  • Kenneth Marek, MD

    Institute for Neurodegenerative Disorders

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 19, 2006

Study Start

July 1, 2006

Primary Completion

June 27, 2008

Study Completion

August 1, 2008

Last Updated

April 3, 2019

Record last verified: 2019-04

Locations

US(1)