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.