NCT00117819

Brief Summary

This study involves study participants who have been clinically diagnosed with parkinsonian syndrome or who are at-risk for parkinsonian syndrome, have a family history of parkinsonian syndrome or exposure to environmental toxins potentially associated with parkinsonian syndrome. Participants will have brain imaging to assess dopamine transporter density. The imaging data coupled with family history and environmental exposure data may provide important information about potential risk factors for parkinsonian syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_2

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

March 1, 2001

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2005

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 2, 2014

Status Verified

April 1, 2014

Enrollment Period

11.8 years

First QC Date

June 30, 2005

Last Update Submit

April 9, 2014

Conditions

Parkinsonian Syndrome

Keywords

parkinsonfamily historydiagnosis

Outcome Measures

Primary Outcomes (1)

  • CIT uptake is the Specific: Nondisplaceable striatal uptake ratio

    2 yrs

Secondary Outcomes (1)

  • CIT uptake measures from at-risk individuals will be compared with healthy subjects.

    2 yrs

Study Arms (1)

[123I]ß CIT and SPECT imaging

EXPERIMENTAL

To assess \[123I\]ß-CIT and SPECT imaging

Drug: [123I]ß CIT and SPECT imaging

Interventions

[123I]ß CIT and SPECT imagingDRUG

To assess \[123I\]ß CIT and SPECT imaging

Also known as: [123I]ß CIT, SPECT imaging
[123I]ß CIT and SPECT imaging

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • A clinical diagnosis of Parkinson's disease (PD), positive family history of PD and/or potential exposure to environmental toxins
  • Normal screening laboratory studies

You may not qualify if:

  • Pregnancy
  • Psychiatric disease other than history of depression
  • Significant medical disease including abnormalities on screening

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 (5)

  • Koller WC, Langston JW, Hubble JP, Irwin I, Zack M, Golbe L, Forno L, Ellenberg J, Kurland L, Ruttenber AJ, et al. Does a long preclinical period occur in Parkinson's disease? Neurology. 1991 May;41(5 Suppl 2):8-13. No abstract available.

    PMID: 2041599BACKGROUND

  • Marek, K., J. Seibyl, et al. (1999). "[123I] ß-CIT/SPECT: Assessment of determinants of variability in progression of Parkinson's disease." Neurology 52: A91-92.

    BACKGROUND

  • Marek, K., J. Seibyl, et al. (1996). "Dopamine transporter and receptor imaging in Parkinsonism. (Presented at the 4th International Congress of Movement Disorders, Vienna, Austria; June, 1996.)." Mov Dis 6.

    BACKGROUND

  • Morrish PK, Sawle GV, Brooks DJ. An [18F]dopa-PET and clinical study of the rate of progression in Parkinson's disease. Brain. 1996 Apr;119 ( Pt 2):585-91. doi: 10.1093/brain/119.2.585.

    PMID: 8800950BACKGROUND

  • 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

MeSH Terms

Conditions

Parkinsonian DisordersDisease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kenneth L. Marek, MD

    President and Senior Scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 8, 2005

Study Start

March 1, 2001

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 2, 2014

Record last verified: 2014-04

Locations

US(1)