title: Revolutionizing Alzheimer's disease and clinical trials through biomarkers.
abstract: The Alzheimer's Association's Research Roundtable met in May 2014 to explore recent progress in developing biomarkers to improve understanding of disease pathogenesis and expedite drug development. Although existing biomarkers have proved extremely useful for enrichment of subjects in clinical trials, there is a clear need to develop novel biomarkers that are minimally invasive and that more broadly characterize underlying pathogenic mechanisms, including neurodegeneration, neuroinflammation, and synaptic dysfunction. These may include blood-based assays and new neuropsychological testing protocols, as well as novel ligands for positron emission tomography imaging, and advanced magnetic resonance imaging methodologies. In addition, there is a need for biomarkers that can serve as theragnostic markers of response to treatment. Standardization remains a challenge, although international consortia have made substantial progress in this area and provide lessons for future standardization efforts.
authors.affiliation: Clinical Memory Research Unit, Lund University, Sweden.
authors.forename: Niklas
authors.initials: N
authors.lastname: Mattsson
authors.affiliation: Alzheimer's Association, Chicago, IL, USA.
authors.forename: Maria C
authors.initials: MC
authors.lastname: Carrillo
authors.affiliation: Eli Lilly & Co, Inc., Indianapolis, IN, USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Dean
authors.affiliation: Avid Radiopharmaceuticals, Philadelphia, PA, USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Devous
authors.affiliation: F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: Tania
authors.initials: T
authors.lastname: Nikolcheva
authors.affiliation: Araclon Grifols, Zaragoza, Spain.
authors.forename: Pedro
authors.initials: P
authors.lastname: Pesini
authors.affiliation: AztraZeneca, Stockholm, Sweden; Department of Clinical Neuroscience, Karolinska Institutet, Sweden.
authors.forename: Hugh
authors.initials: H
authors.lastname: Salter
authors.affiliation: Foundation for the NIH, Bethesda, MD, USA.
authors.forename: William Z
authors.initials: WZ
authors.lastname: Potter
authors.affiliation: Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: Reisa S
authors.initials: RS
authors.lastname: Sperling
authors.affiliation: Washington University School of Medicine, St. Louis, MO, USA.
authors.forename: Randall J
authors.initials: RJ
authors.lastname: Bateman
authors.affiliation: Elverson, PA, USA.
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: Bain
authors.affiliation: Janssen Research and Development, LLC., San Diego, CA, USA.
authors.forename: Enchi
authors.initials: E
authors.lastname: Liu
keywords: Alzheimer's disease; Amyloid; Biomarkers; Blood biomarkers; CSF; Cerebrospinal fluid; Clinical trials; Imaging; MRI; PET; Tau