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Biomarker Standardization Projects


The Global Consortium for Biomarker Standardization will continue to grow and expand as the field identifies novel technologies and techniques for diagnosis of Alzheimer's disease. Currently, projects involving standardization of cerebrospinal fluid biomarkers and harmonization of hippocampal volumetry changes are underway.

Cerebrospinal Fluid Quality Control Program

Launched in fall 2009, the Alzheimer's Association Cerebrospinal Fluid (CSF) Quality Control Program brings together laboratories across the globe with the aim of standardizing the measurement of potential Alzheimer's biomarkers. More than 70 labs in North and South America, Asia, Australia and Europe are participating in the program.

Several studies, including studies involving data from the Alzheimer's Disease Neuroimaging Initiative (ADNI), have shown that levels of biomarkers in CSF are often accurate predictors of which individuals will go on to develop Alzheimer's disease. Of particular interest are levels of beta-amyloid, phosphorylated tau and total tau.

CSF biomarkers may be useful not only in aiding early detection of Alzheimer's and improving diagnostic accuracy, but also in identifying and monitoring the effects of drugs in clinical trials, understanding the molecular changes that lead to Alzheimer's, and helping to ensure that individuals recruited into Alzheimer's clinical trials are on a path toward developing the disease. The latter is especially important in Alzheimer's clinical trials involving people with mild cognitive impairment. In these trials, up to half of study subjects will not go on to develop Alzheimer's, decreasing the overall impact of the study.

The two-part quality control program begins by establishing consistent methods for performing the lumbar punctures required to collect CSF as well as consistent methods for collecting and processing CSF. The second part compares biomarker measurements among participating labs, which have received identical samples. Some CSF samples have normal biomarker levels, while others have “Alzheimer pattern” biomarker levels (low levels of beta-amyloid and high levels of total and phosphorylated tau).

The quality control program and protocols are an outgrowth of discussions held at the Alzheimer's Association International Conference on Alzheimer's Disease 2009 in Vienna, which included input from ADNI representatives, biotechnology companies, pharmaceutical companies and CSF laboratories.

The Alzheimer's Association CSF Quality Control Program is supported by a gift from Dana and Dave Dornsife.

Lumbar Puncture Safety Study

Principal Investigator: Walter A. Kukull, Ph.D.
Institution: National Alzheimer's Coordinating Center

Project Overview: The use of lumbar puncture (LP) to obtain cerebrospinal fluid (CSF) for assays of Alzheimer's-related proteins such as Aβ and tau is increasing in Alzheimer's disease (AD) research and practice (McKhann et al.; Albert et al.; Sperling et al.; Alzheimer's & Dementia 2011).

There appears to be a wide range of attitudes and beliefs about the feasibility of LP, its complications and the value of CSF assays for studies of AD. To address these issues, Kaj Blennow, M.D., Professor of Clinical Neurochemistry at the University of Gothenburg (Sweden), drafted a survey to be completed by European AD investigators engaged in CSF assays for AD research or practice. Dr. Blennow invited representatives from Washington University, St Louis, to develop the survey further and introduce it to the Alzheimer's Disease Centers (ADCs).

The Alzheimer's Association has made a generous grant to the National Alzheimer's Coordinating Center (NACC) to support the survey and provide each ADC with funds to offset the costs of implementing the survey. The ADC survey data will be synthesized with the European survey data.

More information:  Additional information about the LP Safety Study is available on the National Alzheimer's Coordinating Center website.

A Harmonized Protocol for Hippocampal Volumetry: An EADC-ADNI Effort

Principal Investigator: Giovanni B. Frisoni, M.D.
Institution: Fatebenefratelli Association for Research, Brescia, Italy

Currently, there is no standard brain imaging method for diagnosing Alzheimer's disease. It is known, however, that a region of the brain known as the hippocampus decreases in size as the disease develops. Thus, a standardized and validated method to measure the volume of the hippocampus in brain images may be a reliable way to diagnose Alzheimer's disease. Standardized methods are important because often researchers or clinicians will define the borders of the hippocampus in different ways, thus yielding results that are inconsistent across different clinics or laboratories.

In this global effort, Giovanni B. Frisoni, M.D., and colleagues are working to develop standard methods to measure the volume of the hippocampus as part of a collaborative effort among two groups of international researchers, the European Alzheimer's Disease Consortium (EADC) and the Alzheimer's Disease Neuroimaging Initiative (ADNI). This includes developing a standard imaging definition of the hippocampus that all researchers and clinicians can use in the future to obtain consistent results.
This project is made possible by a grant from the Alzheimer's Association International Research Grant program and the generosity of Mike and Barbara Urbut; Stuart and Amy Savitz; and Harriet K. Burnstein. 

More information:  More information about this project and the group's ongoing progress is available on the Hippocampal-Protocol website.

 Minutes from the July 13, 2014 - AAIC Copenhagen HarP Certification meeting

 Minutes from the July 17, 2013 - AAIC Boston Discussion On Progress

For more information

View more information about the Global Biomarker Consortium.



Alzheimer's Association International Conference | July 16-20, 2017, London, England

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