Standards on how the diagnosis of Alzheimer's disease is to be determined in a research setting were defined recently. The standards were the collaborative effort of the National Institute on Aging from the National Institutes of Health (NIA-NIH) and the Alzheimer's Association (AA).

The newly announced standards are to apply to only research and not clinical diagnosis. The criteria for research emphasizes the biomarkers of disease that can be measured with imaging technology and the biologic measures available through spinal fluid samples. The degree of the imaging and biological fluids and imaging will be used in conjunction with levels of cognitive impairment.

The intent is for studies to be more readily compared and understood for both the medical field and general public. By using the same nomenclature and description of disease, it will be easier to describe and compare different stages of disease within studies and across studies.

"In the context of continuing evolution of Alzheimer's research and technologies, the proposed research framework is a logical next step to help the scientific community advance in the fight against Alzheimer's," commented NIA Director Richard J. Hodes, M.D. "The more accurately we can characterize the specific disease process pathologically defined as Alzheimer's disease, the better our chances of intervening at any point in this continuum, from preventing Alzheimer’s to delaying progression."

The process to more clearly unify how clinicians and researchers look at Alzheimer's disease was clarified with the NIA-NIH and AA cooperating in developing diagnostic guidelines that for the first time addressed and recognized a preclinical stage of Alzheimer's disease. This was in response to the need to develop interventions as early as possible.

The research framework proposes to use three general biomarkers: beta-amyloid, tau and neurodegeneration. This does not exclude the potential to expand and include additional markers as they are identified.

"We have to focus on biological or physical targets to zero in on potential treatments for Alzheimer's," said Eliezer Masliah, M.D., director of the Division of Neuroscience at the NIA. "By shifting the discussion to neuropathologic changes detected in biomarkers to define Alzheimer's, as we look at symptoms and the range of influences on development of Alzheimer's, I think we have a better shot at finding therapies, and sooner."

The new standards are intended for research purposes and for the recruitment into clinical trials. But with biomarkers now defined, the use in clinical practice is likely to follow. Should families and clinicians want to incorporate the biomarkers into clinical decision-making, there will be barriers.

Among them, as pointed out by John C. Morris, M.D., director, Knight Alzheimer Disease Research Center, Washington University School of Medicine, is that only clinicians specializing in memory disorders will be able to readily obtain and interpret findings. Steven T. DeKosky, M.D., deputy director, McKnight Brain Institute, University of Florida, told MedPage that third-party insurances do not pay for some of the more specialized imaging, and imaging of tau is not yet approved by the FDA thus not available outside a research protocol.

Having uniform standards in the definition and staging of Alzheimer's disease will have benefits in the long run and will facilitate research. No doubt as more efficient and cost-effective means to identify the currently recognized biomarkers evolve, the guidelines for researchers will be utilized in clinical care.

With the goal of better and earlier treatments, this is a good thing for patients and families.