Validation and Clinical Utility of ELISA Methods for Quantification of Amyloid-β Peptides in Cerebrospinal Fluid Specimens from Alzheimer's Disease Studies

Journal of Alzheimer's Disease

Volumn 45, Issue 2, 2015, Pages 527-542

  Lachno, D Richard ^a   Evert, Barbara A ^b   Maloney, Kaia ^b   Willis, Brian A ^a   Talbot, Jayne A ^a   Vandijck, Manu ^c   Dean, Robert A ^a  

^a ELI LILLY AND COMPANY   (United States)

^b Pharmaceutical Product Development   (United States)

^c FUJIREBIO INC   (Japan)

Author keywords

Alzheimer's disease; amyloid beta peptide; biomarkers; cerebrospinal fluid; enzyme linked immunosorbent assay; validation studies

Indexed keywords

AMYLOID BETA PROTEIN; AMYLOID BETA PROTEIN[1-40]; AMYLOID BETA PROTEIN[1-42]; ENZYME INHIBITOR; LY 2811376; LY 2886721; LY 3002813; PLACEBO; POLYSORBATE 20; SEMAGACESTAT; UNCLASSIFIED DRUG; AMYLOID BETA-PROTEIN (1-42); FUSED HETEROCYCLIC RINGS; N-(3-(2-AMINO-4A,5,7,7A-TETRAHYDRO-4H-FURO(3,4-D)(1,3)THIAZIN-7A-YL)-4-FLUOROPHENYL)-5-FLUOROPICOLINAMIDE; PEPTIDE FRAGMENT; PICOLINIC ACID DERIVATIVE; POLYSORBATE; SURFACTANT;

ALZHEIMER DISEASE; ANALYTIC METHOD; ARTICLE; CALIBRATION; CEREBROSPINAL FLUID; CHEMICAL PARAMETERS; CONTROLLED STUDY; CORRELATION COEFFICIENT; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; ELISA KIT; ENZYME LINKED IMMUNOSORBENT ASSAY; FREEZE THAWING; HUMAN; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PREDICTIVE VALUE; PRIORITY JOURNAL; PROTEIN CLEAVAGE; PROTEIN STABILITY; ROOM TEMPERATURE; SINGLE BLIND PROCEDURE; SINGLE DRUG DOSE; VALIDATION STUDY; DRUG EFFECTS; FEMALE; MALE; METABOLISM; PSYCHOLOGICAL RATING SCALE; REPRODUCIBILITY; TIME;

ALZHEIMER DISEASE; AMYLOID BETA-PEPTIDES; CEREBROSPINAL FLUID; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HETEROCYCLIC COMPOUNDS, 2-RING; HUMANS; MALE; PEPTIDE FRAGMENTS; PICOLINIC ACIDS; POLYSORBATES; PSYCHIATRIC STATUS RATING SCALES; REPRODUCIBILITY OF RESULTS; SURFACE-ACTIVE AGENTS; TIME FACTORS;

EID: 84925358779     PISSN: 13872877     EISSN: 18758908     Source Type: Journal    
DOI: 10.3233/JAD-141686     Document Type: Article

References (34)

1. Siemers ER, Dean RA, Demattos R, May PC (2006) New pathways in drug discovery for Alzheimer's disease. Curr Neurol Neurosci Rep 6, 372-378.
2. Zetterberg H, Mattsson N, Blennow K, Olsson B (2010) Use of theragnostic markers to select drugs for phase II/III trials for Alzheimer disease. Alzheimers Res Ther 2, 32.
3. Siemers E, DeMattos RB, May PC, Dean RA (2010) Role of biochemical Alzheimer's disease biomarkers as end points in clinical trials. Biomark Med 4, 81-89.
4. Cummings JL (2011) Biomarkers in Alzheimer's disease drug development. Alzheimers Dement 7, e13-e44.
5. Hampel H, Wilcock G, Andrieu S, Aisen P, Blennow K, Broich K, Carrillo M, Fox NC, Frisoni GB, Isaac M, Lovestone S, Nordberg A, Prvulovic D, Sampaio C, Scheltens P, Weiner M, Winblad B, Coley N, Vellas B, Oxford Task Force, Group (2011) Biomarkers for Alzheimer's disease therapeutic trials. Prog Neurobiol 95, 579-593.
6. Lee JW, Devanarayan V, Barrett YC, Weiner R, Allinson J, Fountain S, Keller S, Weinryb I, Green M, Duan L, Rogers JA, Millham R, O'Brien PJ, Sailstad J, Khan M, Ray C, Wagner JA (2006) Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res 23, 312-328.
7. Chau CH, Rixe O, McLeod H, Figg WD (2008) Validation of analytic methods for biomarkers used in drug development. Clin Cancer Res 14, 5967-5976.
8. Lee JW (2009) Method validation and application of protein biomarkers: Basic similarities and differences from biotherapeutics. Bioanalysis 1, 1461-1474.
9. Center for Drug Evaluation and Research (CDER), U.S. Department of Health and Human Services, Food and Drug Administration (2001) Bioanalytical Method Validation, Guidance for Industry. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf.
10. Chappell J, Raha N, Durham R, Sharma V, Lawrence J, Tew Z, Lane D, Rohrbacher K, McCush F (2008) Validation of biomarker assays for Alzheimer's disease in plasma and CSF. AAPS, Atlanta, Georgia, AAPS2008-W5005.http://abstracts.aaps.org/published/ContentInfo.aspx?conID=14896.
11. Pica-Mendez AM, Tanen M, Dallob A, Tanaka W, Laterza OF (2010) Nonspecific binding of Aβ42 to polypropylene tubes and the effect of Tween-20. Clin Chim Act 411, 1833.
12. Cullen VC, Fredenburg RA, Evans C, Conliffe PR, Solomon ME (2012) Development and advanced validation of an optimized method for the quantitation of Aβ42 in human cerebrospinal fluid. AAPS J 14, 510-518.
13. US Food and Drug Administration, Guidance for Industry. E6 Good Clinical Practice: Consolidated Guidance. ICH April 1996. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf.
14. US Food and Drug Administration, 21CFR58. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=58.45.
15. Lachno DR, Evert BA, Vanderstichele H, Robertson M, Demattos RB, Konrad RJ, Talbot JA, Racke MM, Dean RA (2013) Validation of assays for measurement of amyloid-β peptides in CSF and plasma specimens from patients with Alzheimer's disease treated with solanezumab. J Alzheimers Dis 34, 897-910.
16. Clinicaltrials.gov. (2010) Identifier: NCT01133405. A safety study of LY2886721 single doses in healthy subjects, https://clinicaltrials.gov/ct2/show/NCT01133405.
17. Visser PJ, Verhey F, Knol DL, Scheltens P, Wahlund LO, Freund-Levi Y, Tsolaki M, Minthon L, Wallin AK, Hampel H, Bürger K, Pirttila T, Soininen H, Rikkert MO, Verbeek MM, Spiru L, Blennow K (2009) Prevalence and prognostic value of CSF markers of Alzheimer's disease pathology in patients with subjective cognitive impairment or mild cognitive impairment in the DESCRIPA study: A prospective cohort study. Lancet Neurol 8, 619-627.
18. Mattsson N, Zetterberg H, Hansson O, Andreasen N, Parnetti L, Jonsson M, Herukka SK, van der Flier WM, Blankenstein MA, Ewers M, Rich K, Kaiser E, Verbeek M, Tsolaki M, Mulugeta E, Rosén E, Aarsland D, Visser PJ, Schröder J, Marcusson J, de Leon M, Hampel H, Scheltens P, Pirttilä T, Wallin A, Jönhagen ME, Minthon L, Winblad B, Blennow K (2009) CSF biomarkers and incipient Alzheimer disease in patients with mild cognitive impairment. JAMA 302, 385-393.
19. Johansson P, Mattsson N, Hansson O, Wallin A, Johansson JO, Andreasson U, Zetterberg H, Blennow K, Svensson J (2011) Cerebrospinal fluid biomarkers for Alzheimer's disease: diagnostic performance in a homogeneous mono-center population. J Alzheimers Dis 24, 537-546.
20. Slaets S, Le Bastard N, Martin JJ, Sleegers K, Van Broeckhoven C, De Deyn PP, Engelborghs S (2013) Cerebrospinal fluid Aβ1-40 improves differential dementia diagnosis in patients with intermediate P-tau181P levels. J Alzheimers Dis 36, 759-767.
21. Engelborghs S, De Vreese K, Van de Casteele T, Vanderstichele H, Van Everbroeck B, Cras P, Martin JJ, Vanmechelen E, De Deyn PP (2008) Diagnostic performance of a CSF-biomarker panel in autopsy-confirmed dementia. Neurobiol Aging 29, 1143-1159.
22. Kaerst L, Kuhlmann A, Wedekind D, Stoeck K, Lange P, Zerr I (2014) Using cerebrospinal fluid marker profiles in clinical diagnosis of dementia with Lewy bodies, Parkinson's disease, and Alzheimer's disease. J Alzheimers Dis 38, 63-73.
23. Vanderstichele H, De Vreese K, Blennow K, Andreasen N, Sindic C, Ivanoiu A, Hampel H, Bürger K, Parnetti L, Lanari A, Padovani A, DiLuca M, Bläser M, Olsson AO, Pottel H, Hulstaert F, Vanmechelen E (2006) Analytical performance and clinical utility of the INNOTEST PHOSPHO-TAU181P assay for discrimination between Alzheimer's disease and dementia with Lewy bodies. Clin Chem Lab Med 44, 1472-1480.
24. Lachno DR, Romeo MJ, Siemers ER, Vanderstichele H, Coart E, Konrad RJ, Zajac JJ, Talbot JA, Jensen HF, Sethuraman G, Demattos RB, May PC, Dean RA (2011) Validation of ELISA methods for quantification of total Tau and phosphorylated-Tau181 in human cerebrospinal fluid with measurement in specimens from two Alzheimer's disease studies. J Alzheimers Dis 26, 531-541.
25. Toombs J, Paterson RW, Schott JM, Zetterberg H (2014) Amyloid-beta 42 adsorption following serial tube transfer. Alzheimers Res Ther 6, 5.
26. Toombs J, Paterson RW, Lunn MP, Nicholas JM, Fox NC, Chapman MD, Schott JM, Zetterberg H (2013) Identification of an important potential confound in CSF AD studies: Aliquot volume. Clin Chem Lab Med 51, 2311-2317.
27. Zimmermann R, Lelental N, Ganslandt O, Maler JM, Kornhuber J, Lewczuk P (2011) Preanalytical sample handling and sample stability testing for the neurochemical dementia diagnostics. J Alzheimers Dis 25, 739-745.
28. May PC, Dean RA, Lowe SL, Martenyi F, Sheehan SM, Boggs LN, Monk SA, Mathes BM, Mergott DJ, Watson BM, Stout SL, Timm DE, Labell ES, Gonzales CR, Nakano M, Jhee SS, Yen M, Ereshefsky L, Lindstrom TD, Calligaro DO, Cocke PJ, Hall DG, Friedrich S, Citron M, Audia JE (2011) Robust central reduction of Aβ in humans with an orally available, non-peptidic β-secretase inhibitor. J Neurosci 31, 16507-16516.
29. Bateman RJ, Wen G, Morris JC, Holtzman DM (2007) Fluctuations of CSF amyloid-β levels: Implications for a diagnostic and therapeutic biomarker. Neurology 68, 666-669.
30. Huang Y, Potter R, Sigurdson W, Santacruz A, Shih S, Ju YE, Kasten T, Morris JC, Mintun M, Duntley S, Bateman RJ (2012) Effects of age and amyloid deposition on Aβ dynamics in the human central nervous system. Arch Neurol 69, 51-58.
31. Slats D, Claassen JA, Spies PE, Borm G, Besse KT, van Aalst W, Tseng J, Sjögren MJ, Olde Rikkert MG, Verbeek MM (2012) Hourly variability of cerebrospinal fluid biomarkers in Alzheimer's disease subjects and healthy older volunteers. Neurobiol Aging 33, 831. e1-9.
32. Huang Y, Potter R, Sigurdson W, Kasten T, Connors R, Morris JC, Benzinger T, Mintun M, Ashwood T, Ferm M, Budd SL, Bateman RJ (2012) β-amyloid dynamics in human plasma. Arch Neurol 69, 1591-1597.
33. Li J, Llano DA, Ellis T, LeBlond D, Bhathena A, Jhee SS, Ereshefsky L, Lenz R, Waring J (2012) Effect of human cerebrospinal fluid sampling frequency on amyloid-β levels. Alzheimers Dement 8, 295-303.
34. Waring J, Slats D, Gonzales C, Dean R, Lee D, Siemers E, Claassen J, Li J, LeBlond D, Slemmon R, Bateman R, Tong G, Fox G (2011) An assessment of variability in CSF biomarkers in clinical experimental models: A meta-analysis. Alzheimers Dement 7, S101.