Primary Outcome Measures:
- Part 1 [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
- Measurement of 123-mZINT brain uptake and distribution [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
- Part 2 [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
- measurement of biodistribution and radiation absorbed dose of 123-I MZINT in the brain SERT [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
- Part 3 [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
- Evaluation for reduction in midbrain and/or striatal SERT density using 123-I MZINT. [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
Intervention Details:
Procedure: [123I] mZINT injection and serial dynamic SPECT imaging
Following bolus intravenous injection of 5 mCi of 123-I mZINT over 15 seconds, serial dynamic SPECT brain acquisitions will be obtained to evaluate the regional brain uptake and washout of activity. Venous blood measures will be obtained with each acquisition and characterization of 123-I mZINT and metabolites will be assessed. Safety assessments will include vital signs, serum chemistries, CBC, urinalysis, and EKG.
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 subjects and 10 PD subjects will be recruited from the IND databases, patient spouses, and the community to participate in this protocol. The study doctor will discuss the study procedures and evaluate the subject for eligibility. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, and a baseline physical and neurological evaluation.
Following bolus intravenous injection of 5 mCi of 123-I mZINT over 15 seconds, serial dynamic SPECT brain acquisitions will be obtained to evaluate the regional brain uptake and washout of activity. Venous blood measures will be obtained with each acquisition and characterization of 123-I mZINT and metabolites will be assessed. Safety assessments will include vital signs, serum chemistries, CBC, urinalysis, and EKG.
Vital signs will be assessed at pre-injection baseline and 15, 30, 60, and 90 minutes following the infusion of 123-I mZINT. An EKG will be obtained at baseline and at 20 and 40 min post 123-I mZINT injection. Adverse events will be assessed when vital signs are obtained. Clinical laboratory tests performed at baseline and after each injection including the following: serum chemistry battery, complete blood count with differential, and urinalysis.