Safety Study of 123-I MZINT in Healthy People and People with Parkinson’s Disease
Official Study Title: Assessment of the Biodistribution and Safety of 123-I MZINT in Healthy Subjects and Parkinson Disease Patients
Sponsor: Institute for Neurodegenerative Disorders (IND)
Clinicaltrials.gov ID: NCT00427674
Study ID: _mZINT_001/002
Summary: The overall objective of this study is to evaluate a drug, [123I] mZINT, as a tool to assess serotonin transporter density (SERT density) in people. Serotonin is a neurotransmitter, derived from tryptophan, that is involved in sleep, depression, memory, and other neurological processes.
Approximately 10 healthy people and 10 people with Parkinson’s disease (PD) will be recruited for this study. All eligible participants will undergo written informed consent and a screening evaluation including clinical laboratory testing, and a physical and neurological evaluation.
After participants receive an intravenous injection of 123-I mZINT, serial dynamic SPECT brain acquisitions (Single Photon Emission Computed Tomography, a procedure in which a gamma camera rotates around the person and takes pictures from many angles) will be obtained to evaluate the brain activity. Blood will be taken with each acquisition, and the safety and characterization of 123-I mZINT will then be assessed. The procedures to assess safety will include the taking of vital signs, serum chemistries, complete blood count, urinalysis, and electrocardiogram (EKG).
Full Details:
PDTrials.org http://www.pdtrials.org/front/trial_...p?trial_id=161ClinicalTrials.gov http://clinicaltrials.gov/ct/show/NCT00427674?order=1