123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor (AIM)
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.
Upper Extremity Tremor
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor (AIM)|
- To obtain a reference set of 123-I ALTROPANE® SPECT images. [ Time Frame: Image obtained at Visit 2 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
2 blood draws and 2 urine collections per subject.
|Study Start Date:||December 2007|
|Study Completion Date:||March 2009|
Subjects with Parkinsonian Tremor (PT)
Subjects with non Parkinsonian Tremor (nPT)
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.
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35233|
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States, 85724|
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|University of Texas|
|Houston, Texas, United States, 77030|