This study is designed to obtain an imaging training set that will be used to evaluate images in future trials. Currently, no radiopharmaceutical diagnostic imaging agent has been approved by the FDA in the U.S. for use in diagnosing Parkinson disease and related Parkinsonian syndromes. The diagnosis of Parkinsonian syndromes in the U.S. is based on clinical criteria only. The goal is to demonstrate that 123I-ALTROPANE® paired with SPECT imaging permits a more accurate early diagnosis of Parkinson disease than a clinical diagnosis by a general neurologist.
This is a prospective, multi-center, non-randomized, open-label, out patient clinical trial which will include up to 90 subjects, male or female, 40 years of age or older. This study is designed to obtain an imaging training set that will be used to evaluate images in future trials. Up to ninety subjects with upper extremity tremor for less than 2 years duration will be enrolled. Of these, at least thirty Parkinsonian syndromes subjects and at least thirty non-Parkinsonian syndromes subjects as diagnosed by a MDS will be enrolled. Subjects will participate in three study visits over the course of the study period. The screening visit will include an assessment of eligibility as well as the collection of the MDS diagnosis. The second visit, during which all subjects receive a single intravenous injection of 123I-ALTROPANE® followed by SPECT imaging, will include appropriate safety assessments before and after dosing. The third visit will include follow-up safety. The subjects' participation in the study will range between 30 and 40 days.
Study Type
OBSERVATIONAL
Enrollment
54
University of Alabama
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
To obtain a reference set of 123-I ALTROPANE® SPECT images.
Time frame: Image obtained at Visit 2
To demonstrate the safety of 123-I ALTROPANE® in subjects with tremor for less than 2 years.
Time frame: Safety assessments conducted at Visit 2, Visit 3, and via telephone follow up
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Texas
Houston, Texas, United States