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F5‐04‐03: TRC‐PAD: Using Run‐In Data for Screen Failure Reduction
Author(s) -
Aisen Paul S.,
Cummings Jeffrey L.,
Sperling Reisa A.
Publication year - 2016
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2016.06.697
Subject(s) - clinical trial , medicine , process (computing) , biomarker , medical physics , computer science , pathology , biochemistry , chemistry , operating system
Background:There is growing consensus that we must fundamentally overhaul the current clinical trial recruitment and assessment process for early intervention trials. Methods: The Global Alzheimer Platform (GAP) brought together academic, industry, advocacy and other Alzheimer’s leaders to identify the necessary components to build large “trial-ready cohorts” (TRC) for preclinical/prodromal AD (PAD) trials (TRC-PAD) and to support a network (GAP-Net) of pre-qualified “trial-ready sites” with specific expertise in and uniform processes for the clinical and biomarker assessments required for prevention trials. The specific goal of the current effort is to build a large TRC-PAD (n1⁄42000; 1000 preclinical/1000 prodromal AD), to facilitate enrollment into ongoing PAD trials using the GAP-Net framework. Results: We designed a process of connecting existing “feeder” registries and studies to a GAP Registry to capture demographic, genetic and longitudinal clinical and cognitive information on older, non-demented individuals interested in trials. The Registry data generates risk scores for AD pathology (specifically, elevated amyloid in brain), that allows efficient selection of candidates for inperson biomarker (amyloid PET scan) and clinical assessment. The results of these assessments, in turn, allow an adaptive statistical algorithm to improve the selection process moving forward. Individuals with PET scans showing amyloid accumulation in brain are invited to join the GAP Cohort, with semi-annual in-person follow-up within the GAP-Net network of pre-qualified clinical sites, from which they can be invited to enroll in prevention trials. Conclusions:We anticipate that this process will dramatically shorten the timeline for preclinical/prodromal trials, and will address a series of scientific hypotheses to guide further development in the field. F5-04-04 EPAD: AN ADAPTIVE TRIAL FOR SECONDARY PREVENTION