RadMD Experts will conduct a series of Educational Webinars throughout 2013.

The first in the series, “Current Issues and Role of Imaging in Alzheimer’s Disease Trials” will be hosted by Dr. Kohkan Shamsi, Principal at RadMD, on April 30th.

All programs will include a 45 minute informative presentation followed by live Q&A.

The Alzheimer’s presentation will include the following topics:

Defining and Developing Imaging Strategies to Optimize Imaging Endpoints – critical in Alzheimer’s studies since MRI and PET are commonly used in AD trials to support clinical efficacy by evaluating brain volume, metabolic activity and in some cases the measurement of amyloid plaque deposits.

The significant Role of MRI in Eligibility and Safety – defining appropriate patient populations to rule out concomitant diseases or age related cognitive decline, as well as monitoring patients throughout the trial due to Amyloid Related Imaging Abnormalities (ARIA) observed in beta-amyloid antibody studies. The FDA has strongly recommended that patients recruited in all AD trials (including therapeutics not directly related to amyloid removal) should be frequently scanned by MRI to monitor and manage patients due to the occurrence of vasogenic edema, micro/macro hemorrhages and superficial siderosis.

To accomplish this in a multicenter trial is very challenging and requires prospective planning, standardization of imaging parameters across the sites, timely submission of imaging data to central reader, fast turnaround time, and quality training and selection of sites and central readers.

In this presentation, methodologies of central evaluations for eligibility, safety and efficacy will be presented and risk management strategies discussed.

Upcoming Topics to be presented throughout 2013:

Site and Central Reads in Early Development

mRECIST Criteria

Imaging in Neurological Clinical Trials

Imaging in Early Development

Risk Management in Centralized Pathology Reviews