Evaluation of the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes

Inclusion Criteria:

- Subject has provided written informed consent before the initiation of any study
related procedures and continues to give willing consent for participation

- Age ≥ 40 years

- Have had upper extremity tremor for < 3 years duration, regardless of presumed
diagnosis or etiology

- Have a UPDRS part III score upon entry of ≤ 16

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.