CTAD 2018 Symposium

Endpoints for early Alzheimer’s disease clinical trials: Interpretation and application of the draft FDA guidance

On-demand Recording

Presented at CTAD 2018 | Symposium moderator: Eric Siemers, MD, Cogstate Ltd, New Haven, CT, USA

Communication 1: Clinical Endpoints in Stage 1, 2 and 3 Disease

Authors: Paul S Aisen, MD1, Reisa Sperling, MD2, Ronald C. Petersen, MD, PhD3, Gary Romano, MD, PhD4, Paul Maruff, PhD5
1 University of Southern California Alzheimer's Therapeutic Research Institute, San Diego, CA, USA
2 Department of Neurology, Brigham and Women’s Hospital, Boston, MA, USA
3 Department of Neurology, Mayo Clinic, Rochester, MN, USA
4 Janssen R&D, Titusville, NJ, USA
5 Cogstate Ltd, Melbourne, Victoria, Australia

Communication 2: Biomarkers in Stage 1, 2 and 3 Disease

Authors: Samantha Budd Haeberlein PhD1, Jose Luis Molinuevo, MD, PhD2, Christopher C. Rowe, PhD3, Maria C. Carrillo PhD4, Clifford R. Jack, Jr., MD5
1 Biogen, Cambridge, MA, USA
2 BarcelonaBeta Brain Research Center, Pasqual Maragall Foundation and Hospital Clinic-IDIBAPS, Barcelona, Spain
3 Department of Molecular Imaging, Austin Health, University of Melbourne, Melbourne, Australia
4 Alzheimer’s Association, Chicago, IL, USA
5 Department of Radiology, Mayo Clinic, Rochester, MN, USA

Communication 3: Approaches to Establishing the Meaningfulness of Treatment Effects

Authors: Chris J. Edgar, PhD1, George Vradenburg, JD2, Jason Hassenstab, PhD3
1 Cogstate Ltd, London, UK
2 UsAgainstAlzheimer’s and Alzheimer’s Disease Patient and Caregiver Engagement (AD PACE), Chevy Chase, MD, USA
3 Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA