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Synergy in Action

2008 Autumn Conference

06 – 07 October, 2008   //   Toronto, Canada

Related Publications

M Heo, AC Leon
Trial designs likely to meet valid long-term Alzheimer’s disease progression effects: learning from the past, preparing for the future
Journal of Biopharmaceutical Statistics. 2010 Jul;20(4):787-802.PMID: 20496206

Day 1 (6 October 2008)

President’s Welcome G Gharabawi
video
SESSION I: Current Understanding of Disease Progression in Alzheimer’s Disease Chair:
R Mohs
Co-chair:
G Grossberg
Introduction and Objectives R Mohs
slides
Understanding Disease Progression in Alzheimer’s Disease H Feldman*
Long-Term Studies in Patients with AD: Do Currently Completed Long-Term Studies in AD Provide Evidence of a Disease Progression Effect? M Sano
slides
video
SESSION II: Imaging, CSF and Plasma Biomarkers: Their Role in Alzheimer’s Disease Chair:
S Potkin
slides
video
Co-chair:
G Small
Process of Amyloid Aggregation: What’s Toxic? C Glabe
slides
video
Amyloid Imaging Markers for Monitoring Clinical Trials G Small
slides
video
Qualification of the Analytical and Clinical Performance of CSF Biomarkers for Use in the ADNI Study L Shaw
slides
video
Structural and Functional Imaging as Biomarkers: Tools for Proof of Concept, Trials and Gene Discovery S Potkin
slides
video
Genetics of Alzheimer’s Disease: How will we use genetic information to develop therapies? J Hardy
slides
video
Panel Discussion: The Role Of Biomarkers and Genetics in the Future Diagnosis and Treatment of Alzheimer’s Disease video
S Potkin
G Small
J Hardy
L Shaw
SESSION III: Trial Designs Likely to Meet Valid Long-Term Disease Progression Effect: Learning from the Past, Preparing tor the Future Chair:
R Anand
Co-chair:
S Romano
Introduction and Objectives G Grossberg
slides
The Use of MRI to Measure Degeneration and Progression: Lessons Learned from MS D Arnold
slides
video
An Industry Viewpoint on Clinical Trials Designs for Disease Modification in Alzheimer’s Disease: Challenges S Romano
slides
video
An Industry Viewpoint on Clinical Trials Designed for Demonstrating Disease Progression in Alzheimer’s Disease: Current Approaches M Ryan
slides
video
An Academic Viewpoint on Clinical Trial Designs for Disease Modification in Alzheimer’s Disease: Challenges R Bullock
slides
video
Panel and Audience Discussion video
R Anand
M Ryan
D Streiner
S Romano
R Bullock

Day 2 (7 October 2008)

SESSION IV: Clinical Endpoints in Alzheimer’s Disease Progression Chair:
G Gharabawi Co-chair:
P Tariot
Introduction and Objectives G Gharabawi
Clinical Endpoints in Long-Term Studies in AD: Cognition L Schneider*
Clinical Endpoints in Long-Term Studies in AD: Behavior P Tariot
slides
 video
Clinical Endpoints in Long-Term Studies in AD: Daily Functioning C Petrie
slides
video
Panel and Audience Discussion  video
L Schneider
P Tariot
G Gharabawi
SESSION V: Regulatory Views on Trial Designs Likely to Meet Valid Long-Term Disease Progression Effect Chair:
R Anand
Co-chair:
H Feldman
Dementia: A European Regulatory Perspective – Challenges, Opportunities, Requirements K Broich
slides
video
Establishing Claims for Long Term Therapeutic Benefit for Alzheimer’s Disease, Including Disease Progression: A US Regulatory Perspective R Mani
slides
video
Establishing Claims for Long Term Therapeutic Benefit for Treatment of Alzheimer’s Disease, Including Disease Progression: A European Academic Regulatory Reviewer’s Perspective C Sampaio
slides
video
Panel Discussion  video
R Anand
H Feldman
K Broich
R Mani
C Sampaio
SESSION VI: Statistical and Outcomes Issues in Alzheimer’s Disease Progression Trials Chair:
A Leon
slides
video
Co-chair:
D Streiner
From Symptomatic Effect to Disease Modifying Effect: A Statistical Methodology Overview in Alzheimer’s Disease Trials R Zhang
slides
video
The Design and Analysis of Alzheimer’s Disease Trials with a Delayed Start Period G Sethuraman
slides
video
Panel and Audience Discussion video
R. Zhang
G. Sethuraman
A. Leon
D. Streiner
SESSION VII: Payers/Policy Issues in Alzheimer’s Disease Progression Trials Chair:
G Gharabawi Co-chair:
L Jonsson
Payers Perspective on Results of Clinical Trials in Alzheimer’s Disease L Jonsson
slides
video
US Perspective on Alzheimer’s Disease Outcomes Measurement L Frank
slides
video
Panel and Audience Discussion video
L Jonsson
L Frank
R Anand
C Petrie
Summary of Meeting G Gharabawi
Adjourn  
* Presentation materials have not as yet been released for publication in this forum.