A phase 2a multi-center study of 18F-FDG PET, safety and tolerability of AZD0530 in mild Alzheimer#s disease

HUMAN CLINICAL TRIAL - CONFIDENTIAL This study represents a multi-center, double-bklind, placebo controlled clinical trial of AZD0530 (FYN kinase inhibitor) in 152 patients with Mild AD. Subjects will be randomized 1:1 to AZD0530 100mg or 125 mg per day vs. placebo for 52 weeks of active treatment. Primary outcome measures include: 1) reductions in fluorodeoxyglucose positron emission tomography (18F-]FDG PET) measurements of the cerebral metabolic rate for glucose (CMRgl) using statistical parametric mapping (SPM) statistical region of interest (sROI) in subjects with mild AD, and 2) Assessment of the safety and tolerability of treatment with AZD0530 over a 52]week period in subjects with mild AD as assessed by analysis of adverse events, including symptoms, and abnormal findings on physical examinations, neurological examinations, standard laboratory tests, and PK analysis of AZD0530. Secondary, exploratory aims include: 1) To assess the effect of treatment with AZD0530 on ADAS-]cog, MMSE, ADCS-]ADL, CDR-]sob, and NPI in participants with mild AD, 2) To assess the effect of treatment with AZD0530 on the rate of change in: total brain volume, ventricular volume, hippocampal volume, and entorhinal thickness, using volumetric magnetic resonance imaging (MRI), 3) To assess the effect of treatment with AZD0530 on CSF biomarkers of AD (particularly CSF total Tau and CSF pTau), and 4) To assess the influence of APOE genotype on the effects of treatment with AZD0530. The study is funded by NIH/NCATS through award to Yale University and was initiated under subcontract to UCSD as the coordinating site. The ssubcontracted coordinating site has changed to USC necessitating new contract establishment which is the purpose of the current eIAF.