Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee
Food and Drug Administration
Center for Drug Evaluation and Research
Holiday Inn, Gaithersburg, Maryland
Agenda for November 18, 2002
The Role of Brain Imaging as an Outcome Measure in Phase 3 Drug Trials in Alzheimer’s Disease
8:00 Call to Order, Introductions
Claudia Kawas, M.D., Acting Chair, PCNSConflict of Interest Statement
Thomas H. Perez., Executive Secretary, PCNSWelcome and Opening Remarks Patricia Love, M.D., Director, Medical Imaging and
Radiopharmaceutical Drug Products
8:15 FDA Overview of Issues Russell Katz, M.D., Director, Neuropharmacological Drug Products
8:30 Overview of Imaging Charles De Carli, M.D.
8:45 Surrogate Endpoints as Measures of Efficacy: Michael Hughes, Ph.D.
Complexities and Limitations
9:00 Questions to presenters
9:15 Volumetric MRI and Related Subjects Clifford Jack, M.D.
Nick Fox, M.D.
H. Cecil Charles, Ph.D.
Michael Grundman, M.D.
10:15 Questions to presenters
10:30 Break
10:45 MR Spectroscopy and PET Michael Weiner, M.D.
Murali Doraiswamy, M.D.
William Jagust, M.D.
Gary Small, M.D.
11:45 Questions to presenters
12:00 Validating Surrogate Endpoints Michael Hughes, Ph.D.
12:15 Questions to presenters
12:30 Lunch Break
1:30 Open Public Hearing
Eric Reiman, M.D., University of Arizona and Good Samaritan Positron Emission Tomography Center
Mary Pendergast, Elan Pharmaceutical Management Corp.
2:30 Discussion of Issues Presented by FDA
3:30 Break
3:45 Continuation of Discussion
5:00 Adjourn