Draft Agenda: Monday, November 18, 2002

Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee with the Medical Imaging Drugs Advisory Committee

Food and Drug Administration

Holiday Inn, Gaithersburg, Maryland

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, PCNS

Conflict of Interest Statement
Sandra Titus, Ph.D., Executive Secretary, PCNS

8:15 FDA Overview of Issues
Overview of Issues, Russell Katz, M.D., Director, Neuropharmacological Drug Products

8:30 Overview of Imaging
Charles De Carli, MD

8:45 Statistical Issues: Imaging as a surrogate Marker

9:00 Questions to the two speakers

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 speakers

10:30 Break

11:00 Open Public Hearing
Eric Reisman, M.D., University of Arizona and Good Samaritan Positron Emission Tomography Center

12:00 Lunch Break

1:00 MR Spectroscopy and PET
Michael Weiner, M.D.
Murali Doraiswamy, MD
William Jaqust, MD

1:45 Imaging as a surrogate Marker
Michael Hughes, Ph.D.

2:00 Questions to speakers

2:30 Discussion of questions posed by FDA

3:30 Break

3:45 Continuation of Discussion

5:00 Adjourn