title: Biomarkers for Alzheimer's disease: academic, industry and regulatory perspectives.
abstract: Advances in therapeutic strategies for Alzheimer's disease that lead to even small delays in onset and progression of the condition would significantly reduce the global burden of the disease. To effectively test compounds for Alzheimer's disease and bring therapy to individuals as early as possible there is an urgent need for collaboration between academic institutions, industry and regulatory organizations for the establishment of standards and networks for the identification and qualification of biological marker candidates. Biomarkers are needed to monitor drug safety, to identify individuals who are most likely to respond to specific treatments, to stratify presymptomatic patients and to quantify the benefits of treatments. Biomarkers that achieve these characteristics should enable objective business decisions in portfolio management and facilitate regulatory approval of new therapies.
authors.affiliation: Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Johann Wolfgang Goethe-University, Heinrich-Hoffmann-Str. 10, 60528 Frankfurt/Main, Germany. harald.hampel@med.uni-frankfurt.de
authors.forename: Harald
authors.initials: H
authors.lastname: Hampel
authors.forename: Richard
authors.initials: R
authors.lastname: Frank
authors.forename: Karl
authors.initials: K
authors.lastname: Broich
authors.forename: Stefan J
authors.initials: SJ
authors.lastname: Teipel
authors.forename: Russell G
authors.initials: RG
authors.lastname: Katz
authors.forename: John
authors.initials: J
authors.lastname: Hardy
authors.forename: Karl
authors.initials: K
authors.lastname: Herholz
authors.forename: Arun L W
authors.initials: AL
authors.lastname: Bokde
authors.forename: Frank
authors.initials: F
authors.lastname: Jessen
authors.forename: Yvonne C
authors.initials: YC
authors.lastname: Hoessler
authors.forename: Wendy R
authors.initials: WR
authors.lastname: Sanhai
authors.forename: Henrik
authors.initials: H
authors.lastname: Zetterberg
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
authors.forename: Kaj
authors.initials: K
authors.lastname: Blennow
mesh_terms: D000544:Alzheimer Disease / Q000175:diagnosis* / Q000235:genetics; D000818:Animals; D015415:Biomarkers; D002986:Clinical Trials as Topic; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000639:trends*; D004345:Drug Industry / Q000639:trends*; D023381:Endpoint Determination; D006801:Humans; D008279:Magnetic Resonance Imaging; D008967:Molecular Biology; D049268:Positron-Emission Tomography; D018570:Risk Assessment
chemical_list: D015415:Biomarkers