The data that define the state of biological markers (biomarkers) for Alzheimer's disease (AD) are reviewed in the articles that follow along with a summary of clinical examination, the gold standard to which any successful biomarker will be compared. Some biomarkers focus on reflecting events specific to AD, such as amyloid β (Aβ) 42 and phospho-tau, while other biomarkers are directed at assessing pathogenic processes that occur in AD as well as other diseases of brain. As will be discussed in the coming articles, both have important roles to serve. AD-specific biomarkers clearly are needed for the differential diagnosis of cognitive impairment in the elderly. Process-specific biomarkers, like markers for inflammation of oxidative damage, although unlikely on their own to be sufficiently discriminating of AD vs. other diseases of brain, will be very useful in determining pharmacologic responses to therapeutics in patients already identified by clinical exam, neuroimaging, and disease-specific biomarkers to be in the early stages of AD. Here we wish to convey the critical need to discover and develop biomarkers for AD and the impact this will have on improving the diagnosis and management of dementia.AD and related dementias are degenerative disorders, primarily of the aged. They are not dissimilar from many other age-related disorders for which clinicians diligently screen and monitor, often with expensive tests and procedures. Such clinical activities are done less with the expectation of reversing disease than with the goal of preventing further end-organ damage. However, what sets hypertension, hypercholesterolemia, and diabetes mellitus apart from AD is that each has biomarkers that can be followed easily and repeatedly, not simply to diagnose but also to monitor response and to optimize treatment. In contrast, the current role of clinical laboratory evaluation for dementia is exclusionary. The development of such biomarkers is critical to translating efficiently the new therapeutic approaches for AD under development by many research groups into treatments for the millions who suffer from AD.Advances in neuroimaging also likely will lead to it serving an important role in understanding dementia and its prodrome. Indeed, the Alzheimer's Disease Neuroimaging Initiative, a large collaboration among the National Institute on Aging, several universitybased research groups, and industry, evaluates the utility of both structural and functional brain imaging to follow the progression of early AD and its prodrome. Imaging probes for selected facets of AD also are being developed; for example, in vivo imaging of brain amyloid appears to show promise even in asymptomatic individuals [3]. However, neuroimaging has its own set of scientific, technical, and practical limitations that, in our opinion, limit this approach from becoming more than complementary to biochemical markers of AD. Put another way, the diagnosis and management of diabetes mellitus would be entirely different if it relied principally on structural ...