ALTROPANE® SPECT Imaging in Patients With Parkinson Disease
Optimizing the Performance of ALTROPANE® SPECT Imaging in Patients With Parkinson Disease
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 parkinson-disease
Started Nov 2006
Longer than P75 for phase_2 parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 6, 2006
CompletedFirst Posted
Study publicly available on registry
November 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 16, 2016
December 1, 2016
5.1 years
November 6, 2006
December 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 years
Secondary Outcomes (1)
Evaluate a state-of-art automated objective striatal analysis tool for ALTROPANE® and to test the reliability of these quantitative outcomes.
2 years
Study Arms (1)
ALTROPANE®
EXPERIMENTALALTROPANE® dosing
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Molecular NeuroImaginglead
- Institute for Neurodegenerative Disorderscollaborator
Study Sites (1)
Molecular NeuroImaging
New Haven, Connecticut, 06510, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danna Jennings, MD
Molecular NeuroImaging
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
November 6, 2006
First Posted
November 8, 2006
Study Start
November 1, 2006
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
December 16, 2016
Record last verified: 2016-12