Exploratory and Safety Study of [F-18]W372

Summary

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.

Timeline

Start

2009-08

Primary completion

2010-02

Completion

2010-02

Drugs

Indications