Status:
TERMINATED
Assessment of the Biodistribution and Safety of 123-I MZINT in Healthy Subjects and Parkinson Disease Patients
Lead Sponsor:
Institute for Neurodegenerative Disorders
Collaborating Sponsors:
Molecular NeuroImaging
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The overall plan of this project is to evaluate \[123I\] mZINT as a tool to assess SERT density in humans. This protocol will be completed in three parts. In Part A serial dynamic SPECT will be acquir...
Detailed Description
All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 10 (6 -Part A and 4 - Part B) healthy sub...
Eligibility Criteria
Inclusion
- Health Control:
- The subject is aged 18-70.
- Written informed consent is obtained.
- The participant has no clinically significant clinical laboratory value and/or clinically significant unstable medical, neurological or psychiatric illness.
- For females, non-child bearing potential or negative urine pregnancy test on day of \[123I\] mZINT injection.
- Willingness to comply with the study protocol
- Parkinson disease:
- The subject is aged 18-70.
- Participants have a clinical diagnosis (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia) of idiopathic Parkinson's disease.
- Hoehn and Yahr stages \< 3.
- Written informed consent is obtained.
- The participant has no clinically significant clinical laboratory value and/or clinically significant unstable medical, neurological or psychiatric illness.
- For females, non-child bearing potential or negative urine pregnancy test on day of \[123I\] mZINT injection.
- Willingness to comply with the study protocol
Exclusion
- All Subjects will be excluded from participation for the following reasons:
- The subject has a clinically significant clinical laboratory values abnormality, and/or medical or psychiatric illness.
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Use of all prescription drugs or non-prescriptions drugs that may effect serotonin such as antidepressants including sertraline, fluoxetine, fluvoxamine, venlafaxine.
- The participant has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV) {American Psychiatric Association, 1994 #2} within the past 2 years.
- Pregnancy
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00427674
Start Date
January 1 2007
End Date
October 1 2009
Last Update
October 6 2010
Active Locations (1)
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1
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510