ALTROPANE® SPECT Imaging in Patients With Parkinson Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALTROPANE®
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson Disease focused on measuring Parkinson, imaging, dopamine transporter
Eligibility Criteria
Inclusion Criteria:
- The participant is 30 years or older at time of PD diagnosis.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of idiopathic Parkinson's disease of < 7 years.
- Hoehn and Yahr stages I-III.
- Negative drug screen
Exclusion Criteria:
- The participant has atypical or drug-induced Parkinson's disease.
- The participant has dementia.
- The participant has a clinically significant clinical laboratory value and/or clinically significant unstable medical or psychiatric illness.
- Treatment within the six months prior to screening with bupropion, methylphenidate, reserpine, alpha methyldopa, or amphetamine.
- The participant has a history of alcohol, narcotic, or any other drug abuse within the past 2 years.
- The participant has received an investigational drug within 60 days of screening visit.
- Pregnancy
Sites / Locations
- Molecular NeuroImaging
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ALTROPANE®
Arm Description
ALTROPANE® dosing
Outcomes
Primary Outcome Measures
Optimize ALTROPANE® dosing and the image acquisition protocol to develop a quantitative imaging outcome that would enhance ALTROPANE® reliability, ease of use and ease of analysis.
Secondary Outcome Measures
Evaluate a state-of-art automated objective striatal analysis tool for ALTROPANE® and to test the reliability of these quantitative outcomes.
Full Information
NCT ID
NCT00397228
First Posted
November 6, 2006
Last Updated
December 15, 2016
Sponsor
Molecular NeuroImaging
Collaborators
Institute for Neurodegenerative Disorders
1. Study Identification
Unique Protocol Identification Number
NCT00397228
Brief Title
ALTROPANE® SPECT Imaging in Patients With Parkinson Disease
Official Title
Optimizing the Performance of ALTROPANE® SPECT Imaging in Patients With Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Molecular NeuroImaging
Collaborators
Institute for Neurodegenerative Disorders
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
After a screening evaluation including baseline clinical laboratory testing, a physical and neurological evaluation, subjects will be asked to undergo an injection of ALTROPANE® followed by up to 60 minutes of serial dynamic imaging. Subjects will undergo a second injection of ALTROPANE® followed by up to 60 minutes of serial dynamic imaging within 2-6 weeks of the injection 1.
Detailed Description
The underlying goal of this open label imaging study is to optimize the imaging outcome for ALTROPANE® in mild to moderate PD subjects. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Subjects with PD (n=15) will be recruited to undergo ALTROPANE® SPECT. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a physical and neurological evaluation. Subjects will be asked to undergo an injection of ALTROPANE® followed by up to 60 minutes of serial dynamic imaging. Subjects will be asked to undergo a second imaging visit two-six weeks following the initial imaging visit to assess the reproducibility of the imaging outcome. The imaging analyses will be performed by an image-processing specialist who will remain masked to clinical severity. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a target region to occipital ratio. Striatal regions of interests for caudate and putamen will be defined and placement standardized based on previously optimized region placement protocols. Imaging data will also be analyzed using an automated objective striatal analysis software package.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson, imaging, dopamine transporter
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALTROPANE®
Arm Type
Experimental
Arm Description
ALTROPANE® dosing
Intervention Type
Drug
Intervention Name(s)
ALTROPANE®
Intervention Description
ALTROPANE® SPECT imaging
Primary Outcome Measure Information:
Title
Optimize ALTROPANE® dosing and the image acquisition protocol to develop a quantitative imaging outcome that would enhance ALTROPANE® reliability, ease of use and ease of analysis.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Evaluate a state-of-art automated objective striatal analysis tool for ALTROPANE® and to test the reliability of these quantitative outcomes.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The participant is 30 years or older at time of PD diagnosis.
Written informed consent is obtained.
Participants have a clinical diagnosis of idiopathic Parkinson's disease of < 7 years.
Hoehn and Yahr stages I-III.
Negative drug screen
Exclusion Criteria:
The participant has atypical or drug-induced Parkinson's disease.
The participant has dementia.
The participant has a clinically significant clinical laboratory value and/or clinically significant unstable medical or psychiatric illness.
Treatment within the six months prior to screening with bupropion, methylphenidate, reserpine, alpha methyldopa, or amphetamine.
The participant has a history of alcohol, narcotic, or any other drug abuse within the past 2 years.
The participant has received an investigational drug within 60 days of screening visit.
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danna Jennings, MD
Organizational Affiliation
Molecular NeuroImaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Molecular NeuroImaging
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ALTROPANE® SPECT Imaging in Patients With Parkinson Disease
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