REGISTRIES AND COHORTS TO ACCELERATE EARLY PHASE ALZHEIMER’S TRIALS. A REPORT FROM THE E.U./U.S. CLINICAL TRIALS IN ALZHEIMER’S DISEASE TASK FORCE
P. Aisen, J. Touchon, S. Andrieu, M. Boada, R. Doody, R.L. Nosheny, J.B. Langbaum, L. Schneider, S. Hendrix, G. Wilcock, J.L. Molinuevo, C. Ritchie, P.-J. Ousset, J. Cummings, R. Sperling, S.T. DeKosky, S. Lovestone, H. Hampel, R. Petersen, V. Legrand, M. Egan, C. Randolph, S. Salloway, M. Weiner, B. Vellas, and Task Force Members
J Prev Alz Dis 2016;3(2):68-74
The EU/US/CTAD Task Force, an international collaboration of AD investigators from industry and academia, met in Barcelona, Spain, on November 4th, 2015, to explore existing and planned patient registries and other clinical trial infrastructure meant to expedite recruitment of large numbers of participants into clinical trials and improve their productivity. The Task Force identified a number of approaches currently being tested around the world, including the use of predictive algorithms to identify individuals likely to have prodromal or preclinical AD, the establishment of clinical trial networks to streamline trials, and reforming the informed consent process to make it less burdensome to both investigators and trial participants. Multi-national systems such as the European Prevention of Alzheimer’s Dementia (EPAD) and the Global Alzheimer’s Platform (GAP) offer value for sponsors, trial sites, and patients by optimizing efforts to find effective disease-modifying and symptomatic treatments.
P. Aisen ; J. Touchon ; S. Andrieu ; M. Boada ; R. Doody ; R.L. Nosheny ; J.B. Langbaum ; L. Schneider ; S. Hendrix ; G. Wilcock ; J.L. Molinuevo ; C. Ritchie ; P.-J. Ousset ; J. Cummings ; R. Sperling ; S.T. DeKosky ; S. Lovestone ; H. Hampel ; R. Petersen ; V. Legrand ; M. Egan ; C. Randolph ; S. Salloway ; M. Weiner ; B. Vellas ; and Task Force Members (2016): Registries and Cohorts to Accelerate Early Phase Alzheimer’s Trials. A Report from the E.U./U.S. Clinical Trials in Alzheimer’s Disease Task Force. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2016.97