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1. The Alzheimer’s Association external quality control program for cerebrospinal fluid biomarkers

Author

Mattsson, Niklas, Andreasson, Ulf, Persson, Staffan, Arai, Hiroyuki, Batish, Sat Dev, Bernardini, Sergio, Bocchio-Chiavetto, Luisella, Blankenstein, Marinus A., Carrillo, Maria C., Chalbot, Sonia, Coart, Els, Chiasserini, Davide, Cutler, Neal, Dahlfors, Gunilla, Duller, Stefan, Fagan, Anne M., Forlenza, Orestes, Frisoni, Giovanni B., Galasko, Douglas, Galimberti, Daniela, Hampel, Harald, Handberg, Aase, Heneka, Michael T., Herskovits, Adrianna Z., Herukka, Sanna-Kaisa, Holtzman, David M., Humpel, Christian, Hyman, Bradley T., Iqbal, Khalid, Jucker, Mathias, Kaeser, Stephan A., Kaiser, Elmar, Kapaki, Elisabeth, Kidd, Daniel, Klivenyi, Peter, Knudsen, Cindy S., Kummer, Markus P., Lui, James, Lladó, Albert, Lewczuk, Piotr, Li, Qiao-Xin, Martins, Ralph, Masters, Colin, McAuliffe, John, Mercken, Marc, Moghekar, Abhay, Molinuevo, José Luis, Montine, Thomas J., Nowatzke, William, O’Brien, Richard, Otto, Markus, Paraskevas, George P., Parnetti, Lucilla, Petersen, Ronald C., Prvulovic, David, de Reus, Herman P.M., Rissman, Robert A., Scarpini, Elio, Stefani, Alessandro, Soininen, Hilkka, Schröder, Johannes, Shaw, Leslie M., Skinningsrud, Anders, Skrogstad, Brith, Spreer, Annette, Talib, Leda, Teunissen, Charlotte, Trojanowski, John Q., Tumani, Hayrettin, Umek, Robert M., Van Broeck, Bianca, Vanderstichele, Hugo, Vecsei, Laszlo, Verbeek, Marcel M., Windisch, Manfred, Zhang, Jing, Zetterberg, Henrik, and Blennow, Kaj

Published
2011
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2. Assessing the commutability of reference material formats for the harmonization of amyloid-β measurements

Author

Bjerke, Maria, Andreasson, Ulf, Kuhlmann, Julia, Portelius, Erik, Pannee, Josef, Lewczuk, Piotr, Umek, Robert M., Vanmechelen, Eugeen, Vanderstichele, Hugo, Stoops, Erik, Lewis, Jennifer, Vandijck, Manu, Kostanjevecki, Vesna, Jeromin, Andreas, Salamone, Salvatore J., Schmidt, Oliver, Matzen, Anja, Madin, Kairat, Eichenlaub, Udo, Bittner, Tobias, Shaw, Leslie M., Zegers, Ingrid, Zetterberg, Henrik, and Blennow, Kaj

Published
2016
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5. The Alzheimer's Association international guidelines for handling of cerebrospinal fluid for routine clinical measurements of amyloid β and tau

Author

Hansson, Oskar, primary, Batrla, Richard, additional, Brix, Britta, additional, Carrillo, Maria C., additional, Corradini, Veronika, additional, Edelmayer, Rebecca M., additional, Esquivel, Rianne N., additional, Hall, Christina, additional, Lawson, John, additional, Bastard, Nathalie Le, additional, Molinuevo, José Luis, additional, Nisenbaum, Laura K., additional, Rutz, Sandra, additional, Salamone, Salvatore J., additional, Teunissen, Charlotte E., additional, Traynham, Christopher, additional, Umek, Robert M., additional, Vanderstichele, Hugo, additional, Vandijck, Manu, additional, Wahl, Simone, additional, Weber, Christopher J., additional, Zetterberg, Henrik, additional, and Blennow, Kaj, additional

Published
2021
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7. Reference measurement procedures for Alzheimerʼs disease cerebrospinal fluid biomarkers: definitions and approaches with focus on amyloid β42

Author

Mattsson, Niklas, Zegers, Ingrid, Andreasson, Ulf, Bjerke, Maria, Blankenstein, Marinus A, Bowser, Robert, Carrillo, Maria C, Gobom, Johan, Heath, Theresa, Jenkins, Rand, Jeromin, Andreas, Kaplow, June, Kidd, Daniel, Laterza, Omar F, Lockhart, Andrew, Lunn, Michael P, Martone, Robert L, Mills, Kevin, Pannee, Josef, Ratcliffe, Marianne, Shaw, Leslie M, Simon, Adam J, Soares, Holly, Teunissen, Charlotte E, Verbeek, Marcel M, Umek, Robert M, Vanderstichele, Hugo, Zetterberg, Henrik, Blennow, Kaj, and Portelius, Erik

Published
2012
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9. Commutability of the certified reference materials for the standardization of β-amyloid 1-42 assay in human cerebrospinal fluid: lessons for tau and β-amyloid 1-40 measurements

Author

Andreasson, Ulf, primary, Kuhlmann, Julia, additional, Pannee, Josef, additional, Umek, Robert M., additional, Stoops, Erik, additional, Vanderstichele, Hugo, additional, Matzen, Anja, additional, Vandijck, Manu, additional, Dauwe, Martine, additional, Leinenbach, Andreas, additional, Rutz, Sandra, additional, Portelius, Erik, additional, Zegers, Ingrid, additional, Zetterberg, Henrik, additional, and Blennow, Kaj, additional

Published
2018
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10. Antibody‐based methods for the measurement of α‐synuclein concentration in human cerebrospinal fluid – method comparison and round robin study

Author

Mollenhauer, Brit, primary, Bowman, Frederick DuBois, additional, Drake, Daniel, additional, Duong, Jimmy, additional, Blennow, Kaj, additional, El‐Agnaf, Omar, additional, Shaw, Leslie M., additional, Masucci, Jennifer, additional, Taylor, Peggy, additional, Umek, Robert M., additional, Dunty, Jill M., additional, Smith, Chris L., additional, Stoops, Erik, additional, Vanderstichele, Hugo, additional, Schmid, Adrian W., additional, Moniatte, Marc, additional, Zhang, Jing, additional, Kruse, Niels, additional, Lashuel, Hilal A., additional, Teunissen, Charlotte, additional, Schubert, Tanja, additional, Dave, Kuldip D., additional, Hutten, Samantha J., additional, and Zetterberg, Henrik, additional

Published
2018
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11. Adjuvant Therapy For Breast Cancer

Author

Muller, Hans-Joachim, Gleiter, Christoph H., Gundert-Remy, Ursula, Melnychuk, David, Panasci, Lawrence C., Coppin, Chris M.L., Goldie, James H., Sauter, Christian, Garey, Joan, Lehrer, Steven, Farkas, Daniel H., Umek, Robert M., Morrison, Briggs W., Atkins, Carl D., Wood, William C., Budman, Daniel, Henderson, I. Craig, Muss, Hyman B., Thor, Ann D., Berry, Donald A., Goldhirsch, Aron, and Gelber, Richard D.

Published
1994
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13. O2‐09‐04: HARMONIZATION OF IMMUNOCHEMICAL METHODS FOR MEASUREMENT OF α‐SYNUCLEIN IN HUMAN CEREBROSPINAL FLUID: A ROUND ROBIN STUDY APPROACH

Author

Hutten, Samantha J., primary, Mollenhauer, Brit, additional, Bowman, F Dubois, additional, Drake, Daniel, additional, Duong, Jimmy, additional, Blennow, Kaj, additional, Corradini, Veronika, additional, El-Agnaf, Omar M.A., additional, Shaw, Leslie M., additional, Masucci, Jennifer, additional, Taylor, Peggy, additional, Umek, Robert M., additional, Dunty, Jill, additional, Smith, Chris L., additional, Stoops, Erik, additional, Vanderstichele, Hugo Marcel, additional, Schmid, Adrien W., additional, Moniatte, Marc, additional, Zhang, Jing, additional, Kruse, Niels, additional, Lashuel, Hilal A., additional, Teunissen, Charlotte E., additional, Schubert, Tanja, additional, Dave, Kuldip D., additional, and Zetterberg, Henrik, additional

Published
2018
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14. O2‐09‐02: A UNIFIED PRE‐ANALYTICAL PROTOCOL FOR HANDLING OF CSF SAMPLES BEFORE ANALYSES OF AD BIOMARKER LEVELS

Author

Hansson, Oskar, primary, Batrla-Utermann, Richard, additional, Bauer, Ekaterina, additional, Baur-Kolarov, Nadja, additional, Brix, Britta, additional, Carrillo, Maria C., additional, Corradini, Veronika, additional, Dean, Robert A., additional, Eichenlaub, Udo, additional, Hall, Christina, additional, Hendrix, James, additional, Lawson, John, additional, Lifke, Valeria, additional, Molinuevo, José Luis, additional, Rutz, Sandra, additional, Salamone, Salvatore J., additional, Traynham, Christopher, additional, Umek, Robert M., additional, Wahl, Simone, additional, Vanderstichele, Hugo Marcel, additional, Vandijck, Manu, additional, and Blennow, Kaj, additional

Published
2018
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16. Cerebrospinal Fluid Biomarkers for Alzheimer’s Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team

Author

Arnerić, Stephen P., primary, Batrla-Utermann, Richard, additional, Beckett, Laurel, additional, Bittner, Tobias, additional, Blennow, Kaj, additional, Carter, Leslie, additional, Dean, Robert, additional, Engelborghs, Sebastiaan, additional, Genius, Just, additional, Gordon, Mark Forrest, additional, Hitchcock, Janice, additional, Kaplow, June, additional, Luthman, Johan, additional, Meibach, Richard, additional, Raunig, David, additional, Romero, Klaus, additional, Samtani, Mahesh N., additional, Savage, Mary, additional, Shaw, Leslie, additional, Stephenson, Diane, additional, Umek, Robert M., additional, Vanderstichele, Hugo, additional, Willis, Brian, additional, and Yule, Susan, additional

Published
2016
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17. Antibody‐based methods for the measurement of α‐synuclein concentration in human cerebrospinal fluid – method comparison and round robin study.

Author

Mollenhauer, Brit, Bowman, Frederick DuBois, Drake, Daniel, Duong, Jimmy, Blennow, Kaj, El‐Agnaf, Omar, Shaw, Leslie M., Masucci, Jennifer, Taylor, Peggy, Umek, Robert M., Dunty, Jill M., Smith, Chris L., Stoops, Erik, Vanderstichele, Hugo, Schmid, Adrian W., Moniatte, Marc, Zhang, Jing, Kruse, Niels, Lashuel, Hilal A., and Teunissen, Charlotte

Subjects
IMMUNOGLOBULINS, SYNUCLEINS, CEREBROSPINAL fluid, NEURODEGENERATION, IMMUNOCHEMISTRY
Abstract

α‐Synuclein is the major component of Lewy bodies and a candidate biomarker for neurodegenerative diseases in which Lewy bodies are common, including Parkinson's disease and dementia with Lewy bodies. A large body of literature suggests that these disorders are characterized by reduced concentrations of α‐synuclein in cerebrospinal fluid (CSF), with overlapping concentrations compared to healthy controls and variability across studies. Several reasons can account for this variability, including technical ones, such as inter‐assay and inter‐laboratory variation (reproducibility). We compared four immunochemical methods for the quantification of α‐synuclein concentration in 50 unique CSF samples. All methods were designed to capture most of the existing α‐synuclein forms in CSF ('total' α‐synuclein). Each of the four methods showed high analytical precision, excellent correlation between laboratories (R2 0.83–0.99), and good correlation with each other (R2 0.64–0.93), although the slopes of the regression lines were different between the four immunoassays. The use of common reference CSF samples decreased the differences in α‐synuclein concentration between detection methods and technologies. Pilot data on an immunoprecipitation mass spectrometry (IP‐MS) method is also presented. Our results suggest that the four immunochemical methods and the IP‐MS method measure similar forms of α‐synuclein and that a common reference material would allow harmonization of results between immunoassays. α‐Synuclein is a synaptic protein that forms intracellular Lewy body inclusions in Parkinson's disease and other so called synuclein aggregation disorders. There are several methods to measure α‐synuclein concentration in human cerebrospinal fluid, where it is a candidate diagnostic and prognostic biomarker. In the current paper, we compared the analytical characteristics of four immunochemical (MSD, BioLegnd, Adx, and Roche) and one mass spectrometry‐based method. Variance component analysis partitions the total variance associated with 49 sample measured by site, kit lot, and replicate. The results show that the different methods measure similar forms of α‐synuclein and that a common reference material would allow for assay harmonization, which will be important in studies evaluating drugs that target α‐synuclein pathology specifically. [ABSTRACT FROM AUTHOR]

Published
2019
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18. Assessing the commutability of reference material formats for the harmonization of amyloid-β measurements

Author

Bjerke, Maria, primary, Andreasson, Ulf, additional, Kuhlmann, Julia, additional, Portelius, Erik, additional, Pannee, Josef, additional, Lewczuk, Piotr, additional, Umek, Robert M., additional, Vanmechelen, Eugeen, additional, Vanderstichele, Hugo, additional, Stoops, Erik, additional, Lewis, Jennifer, additional, Vandijck, Manu, additional, Kostanjevecki, Vesna, additional, Jeromin, Andreas, additional, Salamone, Salvatore J., additional, Schmidt, Oliver, additional, Matzen, Anja, additional, Madin, Kairat, additional, Eichenlaub, Udo, additional, Bittner, Tobias, additional, Shaw, Leslie M., additional, Zegers, Ingrid, additional, Zetterberg, Henrik, additional, and Blennow, Kaj, additional

Published
2015
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19. HARMONIZATION OF IMMUNOCHEMICAL METHODS FOR MEASUREMENT OF α-SYNUCLEIN IN HUMAN CEREBROSPINAL FLUID: A ROUND ROBIN STUDY APPROACH

Author

Hutten, Samantha J., Mollenhauer, Brit, Bowman, F Dubois, Drake, Daniel, Duong, Jimmy, Blennow, Kaj, Corradini, Veronika, El-Agnaf, Omar M.A., Shaw, Leslie M., Masucci, Jennifer, Taylor, Peggy, Umek, Robert M., Dunty, Jill, Smith, Chris L., Stoops, Erik, Vanderstichele, Hugo Marcel, Schmid, Adrien W., Moniatte, Marc, Zhang, Jing, Kruse, Niels, Lashuel, Hilal A., Teunissen, Charlotte E., Schubert, Tanja, Dave, Kuldip D., and Zetterberg, Henrik

Published
2018
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20. A UNIFIED PRE-ANALYTICAL PROTOCOL FOR HANDLING OF CSF SAMPLES BEFORE ANALYSES OF AD BIOMARKER LEVELS

Author

Hansson, Oskar, Batrla-Utermann, Richard, Bauer, Ekaterina, Baur-Kolarov, Nadja, Brix, Britta, Carrillo, Maria C., Corradini, Veronika, Dean, Robert A., Eichenlaub, Udo, Hall, Christina, Hendrix, James, Lawson, John, Lifke, Valeria, Molinuevo, José Luis, Rutz, Sandra, Salamone, Salvatore J., Traynham, Christopher, Umek, Robert M., Wahl, Simone, Vanderstichele, Hugo Marcel, Vandijck, Manu, and Blennow, Kaj

Published
2018
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22. O3‐02–06: Elevated cerebrospinal fluid BACE1 activity in incipient Alzheimer's disease

Author

Zetterberg, Henrik, primary, Andreasson, Ulf, additional, Hansson, Oskar, additional, Wu, Guoxin, additional, Sankaranarayanan, Sethu, additional, Andersson, Malin E., additional, Buchhave, Peder, additional, Londos, Elisabet, additional, Umek, Robert M., additional, Minthon, Lennart, additional, Simon, Adam J., additional, and Blennow, Kaj, additional

Published
2008
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26. Book Reviews

Author

Lee, Henry C., primary, Umek, Robert M., additional, and Skoog, Donald P., additional

Published
1994
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30. C/EBPalpha Is Required to Maintain Postmitotic Growth Arrest in Adipocytes.

Author

Tao, Heng and Umek, Robert M.

Subjects
*CARRIER proteins, *ANTIMITOTIC agents, *CELL differentiation, *ANTISENSE DNA
Abstract

Terminal differentiation is often coupled with irreversible loss of proliferative potential. The CCAAT enhancer binding protein alpha (C/EBPalpha) preferentially accumulates in postmitotic, differentiated 3T3-L1 adipocytes but declines during tumor necrosis factor alpha (TNFalpha)-induced dedifferentiation. We have discovered that this decline in C/EBPalpha correlates with an increased mitotic growth potential. In order to further investigate the antimitotic activity of C/EBPalpha, we introduced antisense C/EBPalpha RNA into 3T3-L1 cells to block endogenous C/EBPalpha expression. When treated according to the standard differentiation protocol, stable cells lines harboring antisense C/EBPalpha RNA did not differentiate into fat-laden adipocytes, consistent with previous findings (Lin F, Lane MD, Genes Dev 1992;6:533-544). We found that these undifferentiated cells expressing antisense-C/EBPalpha can reenter the cell cycle after mitogenic stimulation at a time in development when parental 3T3-L1 cells cannot. Moreover, the expression profiles of the growth-arrest-associated genes gas1 and gas2 revealed that the antisense C/EBPalpha-expressing cells withdrew from the cell cycle after the period of clonal expansion but failed to progress to the state of least proliferative potential characteristic of terminally differentiated adipocytes. [ABSTRACT FROM AUTHOR]

Published
2000
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32. Bioelectronic Detection of Point Mutations Using Discrimination of the H63DPolymorphism of the HfeGene as a Model

Author

Umek, Robert M., Lin, Sharon S., Chen, Yin-Peng, Irvine, Bruce, Paulluconi, Gabrielle, Chan, Vivian, Chong, Yoochul, Cheung, Lina, Vielmetter, Jost, and Farkas, Daniel H.

Abstract

A bioelectronic detection platform has recently been developed that facilitates the detection and characterization of nucleic acids. The DNA chip platform is compatible with homogeneous assays because separate labeling and wash steps are not required. A one-step, bioelectronic detection assay was developed to genotype patient samples with respect to the H63Dpolymorphism of the Hfegene, associated with hereditary hemochromatosis.

Published
2000
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35. Adjuvant Therapy for Breast Cancer.

Author

Farkas, Daniel H. and Umek, Robert M.

Subjects
*LETTERS to the editor, *ADJUVANT treatment of cancer
Abstract

A letter to the editor is presented in response to the article "c-erbB-2 expression and response to adjuvant therapy in women with node-positive early breast cancer," by H. B. Muss, A. D. Thor, D. A. Berry and colleagues in the May 5, 1994 issue.

Published
1994
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36. Cerebrospinal Fluid Biomarkers for Alzheimer's Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team.

Author

Arnerić SP, Batrla-Utermann R, Beckett L, Bittner T, Blennow K, Carter L, Dean R, Engelborghs S, Genius J, Gordon MF, Hitchcock J, Kaplow J, Luthman J, Meibach R, Raunig D, Romero K, Samtani MN, Savage M, Shaw L, Stephenson D, Umek RM, Vanderstichele H, Willis B, and Yule S

Subjects
Clinical Trials as Topic, Drug Approval, Drug Discovery, Humans, Alzheimer Disease cerebrospinal fluid, Biomarkers cerebrospinal fluid
Abstract

Alzheimer's disease (AD) drug development is burdened with the current requirement to conduct large, lengthy, and costly trials to overcome uncertainty in patient progression and effect size on treatment outcome measures. There is an urgent need for the discovery, development, and implementation of novel, objectively measured biomarkers for AD that would aid selection of the appropriate subpopulation of patients in clinical trials, and presumably, improve the likelihood of successfully evaluating innovative treatment options. Amyloid deposition and tau in the brain, which are most commonly assessed either in cerebrospinal fluid (CSF) or by molecular imaging, are consistently and widely accepted. Nonetheless, a clear gap still exists in the accurate identification of subjects that truly have the hallmarks of AD. The Coalition Against Major Diseases (CAMD), one of 12 consortia of the Critical Path Institute (C-Path), aims to streamline drug development for AD and related dementias by advancing regulatory approved drug development tools for clinical trials through precompetitive data sharing and adoption of consensus clinical data standards. This report focuses on the regulatory process for biomarker qualification, briefly comments on how it contrasts with approval or clearance of companion diagnostics, details the qualifications currently available to the field of AD, and highlights the current challenges facing the landscape of CSF biomarkers qualified as hallmarks of AD. Finally, it recommends actions to accelerate regulatory qualification of CSF biomarkers that would, in turn, improve the efficiency of AD therapeutic development.

Published
2017
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