PHASE II STUDY OF IVIG FOR ALZHEIMER'S DISEASE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The overall goal of this double-blind Phase II study is to further evaluate the safety, efficacy and biological effects of IVIg in the treatment of Alzheimer's disease (AD). This study will be carried out at a single site (Weill Medical College of Cornell University/New York Presbyterian Hospital). 24 patients with mild to moderate AD capable of giving or delegating informed consent will be randomly assigned to receive either IVIg or saline placebo for six months. This study includes comparison of four dosing regimens of IVIg (0.4g/kg/2 weeks, 0.8g/kg/4weeks, 0.2g/kg/2weeks and 0.4g/kg/4 weeks). Patients will have a 33% chance of receiving placebo. Cognitive, behavioral and functional measures will be collected at baseline, three months and six months of treatment and after a six-week washout period during which patients receive no study drug. Plasma samples will be collected before and after infusions of study drug, and subjects will undergo a lumbar punctures before and after the six months of treatment for cerebrospinal fluid (CSF) biomarker analyses. In addition, Positron Emission Tomography (PET) imaging substudies will be performed at two timepoints during the study.