A Cross-Over, Multi-Center Trial to Evaluate the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes

Exclusion Criteria

• •Any clinically significant or unstable physical or psychological illness based on medical history or physical examination at screening, as determined by the investigator
• •Structural brain abnormality affecting the entire brain (e.g., normal pressure hydrocephalus) or the striatum (e.g., local tumor or stroke)
• •Any clinically significant abnormal laboratory results obtained at screening and as determined by the investigator
• •Any clinically significant abnormal electrocardiogram (ECG) results obtained at screening and as determined by the investigator
• •Any history of drug, narcotic, or alcohol abuse within 2 years before the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition, revised (DSM-IV-TR \[American Psychiatric Association, 1994\])
• •Positive urine drug screen for opiates, cocaine, or amphetamines at screening
• •Positive pregnancy test before imaging
• •Participation in an investigational drug or device clinical trial within 30 days before the date of informed consent
• •Previous scan with any DAT imaging agent (e.g. \[123I\]NAV5001, Altropane, DaTscan, DOPASCAN)
• •Any exposure to radiopharmaceuticals within 30 days before the date of informed consent
• •Breast-feeding
• •Inability to lie supine for 1 hour
• •Any thyroid disease other than adequately treated hypothyroidism
• •Known sensitivity or allergy to iodine or iodine containing products
• •Treatment within the 30 days before the date of imaging with amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline, paroxetine, or citalopram.