Exploratory and Safety Study of [F-18]W372
PHASE: Phase 0, Exploratory Study
OBJECTIVES: To collect drug safety, bio-distribution and dosimetry data, to begin collection of PET/CT imaging data, to acquire experience to improve study design and the conduct of future studies.
DESIGN: Exploratory, open label, non-randomized, multi-center study.
DURATION: Three visits - one screening, one imaging, and one follow-up visit at 24 hours post-dose
PROCEDURES: Informed consent, collection of demographic information and medical history, administration of mental status exam, physical examination, vital signs, 12-lead ECGs, routine blood tests to assess major organ functions, complete blood counts and clinical chemistries for safety, dosing with [F-18]W372, PET imaging scans of brain (in sixteen subjects), whole body PET imaging and urine collections for dosimetry evaluation (in four subjects only), observation and interviews following imaging to collect adverse events.
SUBJECTS: Twenty (20) subjects ≥ 55 years old:
Group 1 will consist of 10 subjects who have a low probability of being currently positive for Alzheimer's Disease (AD) as defined by the protocol criteria (MMSE ≥ 28). Four of the 10 subjects will undergo whole body PET imaging for dosimetry evaluations, and 6 of the 10 subjects will undergo PET imaging of the brain only.
Group 2 will consist of 10 subjects who have a high probability of currently being positive for AD as defined by the protocol criteria (MMSE < 24); these 10 subjects will undergo PET imaging of the brain only.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Phase 0, Open Label, Non-randomized, Multi-center, Exploratory and Safety Study of [F-18]W372|
- Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug. [ Time Frame: Three (3) study visits, including the initial screening visit, the imaging visit, and the 24 hour follow-up visit ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Approximately twenty (20) adult subjects including ten (10) healthy volunteers and ten (10) high probability AD subjects, as defined by protocol criteria
The individual doses of [F-18]W372 contain a maximum of 20 mCi for normal volunteers and 10 mCi for high probability AD subjects.
The single IP dose is administered to the study subject immediately prior to the start of PET imaging.
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|United States, California|
|University of California, Irvine|
|Irvine, California, United States, 92697-5020|
|Principal Investigator:||Lydia Min-Ying Su, PhD||University of California, Irvine|