A Study of Brain Imaging With Nuclear Medicine Technology in Individuals With and at Risk for Parkinson's Disease

NCT ID: NCT00117819

Last Updated: 2014-05-02

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

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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The brain imaging is conducted at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. The imaging procedure occurs over a two day period.

On the first day participants are injected with \[123I\]ß CIT, an investigational radioactive material that localizes in the brain. Study participants will also have a thorough neurologic examination and standard neuropsychological testing, including testing of memory, concentration, abstraction and visual spatial functions.

Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure will be used to obtain SPECT (single photon emission computed tomography) images of the brain.

Participants may be contacted to repeat these procedures every 12 to 18 months.

Conditions

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Parkinsonian Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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[123I]ß CIT and SPECT imaging

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

Group Type EXPERIMENTAL

[123I]ß CIT and SPECT imaging

Intervention Type DRUG

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

Interventions

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[123I]ß CIT and SPECT imaging

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

Intervention Type DRUG

Other Intervention Names

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[123I]ß CIT SPECT imaging

Eligibility Criteria

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Inclusion Criteria

* 22 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

Exclusion Criteria

* Pregnancy
* Psychiatric disease other than history of depression
* Significant medical disease including abnormalities on screening
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University

OTHER

Sponsor Role collaborator

Albany Medical College

OTHER

Sponsor Role collaborator

Institute for Neurodegenerative Disorders

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Marek, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth L. Marek, MD

Role: PRINCIPAL_INVESTIGATOR

President and Senior Scientist

Locations

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Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 2041599 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 8800950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7574455 (View on PubMed)

Other Identifiers

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At-Risk

Identifier Type: -

Identifier Source: org_study_id

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