Food and Drug Administration

Peripheral and Central Nervous System Drugs Advisory Committee

November 18, 2002

Slides

Surrogate Marker: A Laboratory Measurement or a Physical Sign Used as a Substitute for a Clinically Meaningful Endpoint that Measures Directly How a Patient Feels, Functions, or Survives, Dr. Katz, FDA (HTM) (PPT)

Population Based Quantitative Brain Imaging: Establishing What is Normal, Dr. Charles DeCarli, MD, University of California at Davis (HTM) (PPT)

Surrogate Endpoints as Measures of Efficacy: Complexities & Limitations, Dr. Michael Hughes, PhD, Harvard School of Public Health (HTM) (PPT)

Structural MRI as a Biomarker of Disease Progression in AD, Dr. Clifford Jack, MD, FDA (HTM) (PPT)

MRI, Rates of Atrophy and Alzheimer's Disease, Nick Fox, London, England (HTM) (PPT)

Quantitaaaaative Imaging: Protocol Development and Quality Assurance Issues for Medical Imaging in Clinical Trails, Dr. H Charles, PhD, Duke University Medical Center (HTM) (PPT)

MRI as a Potential Surrogate Marker in the ADCS MCI Trial, Dr. Michael Grundman, MD, MPH, FDA (HTM) (PPT)

MR Spectrocopy and MRI to Measure Treatment of Neurodegeneration, Michael Weiner, Universisty of California, S.F. (HTM) (PPT)

MR Spectroscopy and Alzheimer's Disease, P. Doraiswamy, MBBS, Duke University Medical Center (HTM) (PPT)

Why is PET a Good Potential Surrogate Marker in AD?, Dr. William Jagust, MD (HTM) (PPT)

PET and Dementia, Dr. Gary Small, MD, University of California, (HTM) (PPT)

Validating Surrogate Endpoints, Dr. Michael Hughes, PhD, Harvard School of Public Health (HTM) (PPT)

Open Public Hearing

Brain Imaging in Phase 3 Clinical Trials of Drugs for the Putative Treatment and Prevention of Alzheimer's Dementia, Dr. Eric Reiman, MD, University of Arizona (HTM) (PPT)

AIDS: 40,000,000 Infected. 00,000,000 Cured., Mary Pendergast, FDA (HTM) (PPT)