A Study of Brain Imaging With Nuclear Medicine Technology in Individuals With and at Risk for Parkinson's Disease
Primary Purpose
Parkinsonian Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
[123I]ß CIT and SPECT imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinsonian Syndrome focused on measuring parkinson, family history, diagnosis
Eligibility Criteria
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
Sites / Locations
- Institute for Neurodegenerative Disorders
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[123I]ß CIT and SPECT imaging
Arm Description
To assess [123I]ß-CIT and SPECT imaging
Outcomes
Primary Outcome Measures
CIT uptake is the Specific: Nondisplaceable striatal uptake ratio
Secondary Outcome Measures
CIT uptake measures from at-risk individuals will be compared with healthy subjects.
Full Information
NCT ID
NCT00117819
First Posted
June 30, 2005
Last Updated
April 9, 2014
Sponsor
Institute for Neurodegenerative Disorders
Collaborators
Indiana University, Albany Medical College
1. Study Identification
Unique Protocol Identification Number
NCT00117819
Brief Title
A Study of Brain Imaging With Nuclear Medicine Technology in Individuals With and at Risk for Parkinson's Disease
Official Title
Dynamic SPECT Imaging With [123I] B-CIT in Individuals With Parkinsonian Syndrome (PS) and in Individuals at Risk for Parkinsonian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for Neurodegenerative Disorders
Collaborators
Indiana University, Albany Medical College
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsonian Syndrome
Keywords
parkinson, family history, diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
232 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[123I]ß CIT and SPECT imaging
Arm Type
Experimental
Arm Description
To assess [123I]ß-CIT and SPECT imaging
Intervention Type
Drug
Intervention Name(s)
[123I]ß CIT and SPECT imaging
Other Intervention Name(s)
[123I]ß CIT, SPECT imaging
Intervention Description
To assess [123I]ß CIT and SPECT imaging
Primary Outcome Measure Information:
Title
CIT uptake is the Specific: Nondisplaceable striatal uptake ratio
Time Frame
2 yrs
Secondary Outcome Measure Information:
Title
CIT uptake measures from at-risk individuals will be compared with healthy subjects.
Time Frame
2 yrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth L. Marek, MD
Organizational Affiliation
President and Senior Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2041599
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
8800950
Citation
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.
Results Reference
background
PubMed Identifier
7574455
Citation
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. Erratum In: Ann Neurol. 1996 Mar;39(3):417. van Dyck, C [added].
Results Reference
background
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A Study of Brain Imaging With Nuclear Medicine Technology in Individuals With and at Risk for Parkinson's Disease
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