title: Research and standardization in Alzheimer's trials: reaching international consensus.
abstract: Alzheimer's disease (AD) is an epidemic facing the entire world. Increased knowledge gained during the past 25 years indicates that AD falls along a clinical and neuropathological spectrum represented as a continuum that extends from preclinical disease in which there are no symptoms, through early symptomatic phases, and finally to AD dementia. The Alzheimer's research community recognizes that imaging, body fluids, and cognitive biomarkers contribute to enhanced diagnostic confidence for AD. There has also been emerging consensus regarding the use of AD biomarkers in clinical trials. The use of biomarkers in clinical trials and practice is hampered by the lack of standardization. In response to the emerging need for standardization, an international meeting of AD researchers was held in Melbourne, Australia, in March 2012 to bring together key researchers, clinicians, industry, and regulatory stakeholders with the aim of generating consensus on standardization and validation of cognitive, imaging, and fluid biomarkers, as well as lifestyle parameters used in research centers worldwide.
authors.affiliation: Alzheimer's Association, Chicago, Illinois, USA. Maria.Carrillo@alz.org
authors.forename: Maria C
authors.initials: MC
authors.lastname: Carrillo
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Rowe
authors.forename: Cassandra
authors.initials: C
authors.lastname: Szoeke
authors.forename: Colin L
authors.initials: CL
authors.lastname: Masters
authors.forename: David
authors.initials: D
authors.lastname: Ames
authors.forename: Tim
authors.initials: T
authors.lastname: O'Meara
authors.forename: S Lance
authors.initials: SL
authors.lastname: Macaulay
authors.forename: Andrew
authors.initials: A
authors.lastname: Milner
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Ellis
authors.forename: Paul
authors.initials: P
authors.lastname: Maruff
authors.forename: Stephanie R
authors.initials: SR
authors.lastname: Rainey-Smith
authors.forename: Ralph N
authors.initials: RN
authors.lastname: Martins
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: Bain
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Head
mesh_terms: D000544:Alzheimer Disease / Q000175:diagnosis* / Q000628:therapy*; D015415:Biomarkers / Q000032:analysis*; D002986:Clinical Trials as Topic / Q000592:standards*; D032921:Consensus; D006801:Humans
chemical_list: D015415:Biomarkers