Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Navidea Biopharmaceuticals
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Evaluation of the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes
