ISCTM 2008 Autumn Conference
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 videoCo-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 in process) | 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 in process) | 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 videoCo-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. | |