used in the adoption of the new technology, incorporation of biomarker testing in clinical practice, and impact of targeting a surrogate marker of disease incidence; and

•   the studies needed (types, design, execution) for validation and standardization of biomarkers for diagnosing pre-dementia and predicting progression to the dementia phase of AD.

This report is limited to a review of workshop speaker presentations and commentary by panelists and participants and is not intended to be a thorough review of all published literature.

BACKGROUND

Currently, the most widely used AD diagnostic guidelines are those proposed in 1984 by the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS, now the National Institute of Neurological Disorders and Stroke [NINDS]) and the Alzheimer’s Disease and Related Disorders Association (ADRDA, now the Alzheimer’s Association). William Thies, chief medical and scientific officer for the Alzheimer’s Association and co-chair of the session, noted that in 1984, there was a sense that AD was a binary condition. However, scientific advances over the past decade now indicate that AD is a continuous, progressive cognitive disease, most likely beginning asymptomatically many years before dementia is apparent. This presents challenges when trying to study the patient population including characterizing patients as normal, at risk, prodromal, or having clinical dementia.

In 2007, the International Working Group for New Research Criteria for the Diagnosis of Alzheimer’s Disease proposed revisions to the long-standing NINCDS-ADRDA guidelines, followed by nomenclature clarifications in 2010 (Dubois et al., 2007, 2010). Phillip Scheltens, director of the Alzheimer Center at the VU University Medical Center, The Netherlands, and a senior author of the 2007 and 2010 International Working Group publications, said that one goal of the group was to update the guidelines to encompass earlier stages of AD, or prodomal AD.

With similar intent, in 2010, three working groups convened by the NIA and Alzheimer’s Association issued revised guidelines for the diagnosis of AD in a set of four publications (Albert et al., 2011; Jack et al., 2011; McKhann et al., 2011; Sperling et al., 2011). Each of these efforts, the International Working Group and the NIA-AA efforts, included international participants and individuals who took part in both efforts. The NIA-AA guidelines are split into three sets of diagnostic criteria: the first



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