{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T17:48:42Z","timestamp":1790704122248,"version":"4.1.0"},"reference-count":39,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2025,2,5]],"date-time":"2025-02-05T00:00:00Z","timestamp":1738713600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2025,2,5]],"date-time":"2025-02-05T00:00:00Z","timestamp":1738713600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Pharmacokinet"],"DOI":"10.1007\/s40262-025-01482-8","type":"journal-article","created":{"date-parts":[[2025,2,5]],"date-time":"2025-02-05T12:49:24Z","timestamp":1738759764000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Clinical Pharmacokinetics of Oral ALZ-801\/Valiltramiprosate in a 2-Year Phase 2 Trial of APOE4 Carriers with Early Alzheimer\u2019s Disease"],"prefix":"10.1007","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5104-6231","authenticated-orcid":false,"given":"John A.","family":"Hey","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremy Y.","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Abushakra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean F.","family":"Schaefer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aidan","family":"Power","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pat","family":"Kesslak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jijo","family":"Paul","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Tolar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,2,5]]},"reference":[{"issue":"5","key":"1482_CR1","doi-asserted-by":"publisher","first-page":"370","DOI":"10.7326\/0003-4819-148-5-200803040-00008","volume":"148","author":"A Qaseem","year":"2008","unstructured":"Qaseem A, Snow V, Cross JT Jr, Forciea MA, Hopkins R Jr, Shekelle P, et al. Current pharmacologic treatment of dementia: a clinical practice guideline from the American College of Physicians and the American Academy of Family Physicians. Ann Intern Med. 2008;148(5):370\u20138. https:\/\/doi.org\/10.7326\/0003-4819-148-5-200803040-00008.","journal-title":"Ann Intern Med"},{"issue":"2","key":"1482_CR2","doi-asserted-by":"publisher","first-page":"197","DOI":"10.14283\/jpad.2022.30","volume":"9","author":"S Budd Haeberlein","year":"2022","unstructured":"Budd Haeberlein S, Aisen PS, Barkhof F, Chalkias S, Chen T, Cohen S, et al. Two randomized Phase 3 studies of aducanumab in early Alzheimer\u2019s disease. J Prev Alzheimers Dis. 2022;9(2):197\u2013210. https:\/\/doi.org\/10.14283\/jpad.2022.30.","journal-title":"J Prev Alzheimers Dis."},{"issue":"1","key":"1482_CR3","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1056\/NEJMoa2212948","volume":"388","author":"CH van Dyck","year":"2023","unstructured":"van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, et al. Lecanemab in early Alzheimer\u2019s disease. N Engl J Med. 2023;388(1):9\u201321. https:\/\/doi.org\/10.1056\/NEJMoa2212948.","journal-title":"N Engl J Med"},{"issue":"6","key":"1482_CR4","doi-asserted-by":"publisher","first-page":"512","DOI":"10.1001\/jama.2023.13239","volume":"330","author":"JR Sims","year":"2023","unstructured":"Sims JR, Zimmer JA, Evans CD, Lu M, Ardayfio P, Sparks J, et al. Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA. 2023;330(6):512\u201327. https:\/\/doi.org\/10.1001\/jama.2023.13239.","journal-title":"JAMA"},{"issue":"1","key":"1482_CR5","doi-asserted-by":"publisher","first-page":"95","DOI":"10.1186\/s13195-020-00663-w","volume":"12","author":"M Tolar","year":"2020","unstructured":"Tolar M, Abushakra S, Hey JA, Porsteinsson A, Sabbagh M. Aducanumab, gantenerumab, BAN2401, and ALZ-801\u2014the first wave of amyloid-targeting drugs for Alzheimer\u2019s disease with potential for near term approval. Alzheimers Res Ther. 2020;12(1):95. https:\/\/doi.org\/10.1186\/s13195-020-00663-w.","journal-title":"Alzheimers Res Ther."},{"key":"1482_CR6","doi-asserted-by":"publisher","DOI":"10.3389\/fneur.2022.862369","volume":"13","author":"CG Withington","year":"2022","unstructured":"Withington CG, Turner RS. Amyloid-related imaging abnormalities with anti-amyloid antibodies for the treatment of dementia due to Alzheimer\u2019s disease. Front Neurol. 2022;13: 862369. https:\/\/doi.org\/10.3389\/fneur.2022.862369.","journal-title":"Front Neurol"},{"issue":"7","key":"1482_CR7","doi-asserted-by":"publisher","first-page":"811","DOI":"10.1007\/s40265-024-02067-8","volume":"84","author":"JA Hey","year":"2024","unstructured":"Hey JA, Abushakra S, Blennow K, Reiman EM, Hort J, Prins ND, et al. Effects of oral ALZ-801\/Valiltramiprosate on plasma biomarkers, brain hippocampal volume, and cognition: results of 2-year single-arm, open-label, phase 2 trial in APOE4 carriers with early Alzheimer\u2019s disease. Drugs. 2024;84(7):811\u201323. https:\/\/doi.org\/10.1007\/s40265-024-02067-8.","journal-title":"Drugs"},{"issue":"7","key":"1482_CR8","doi-asserted-by":"publisher","first-page":"825","DOI":"10.1007\/s40265-024-02068-7","volume":"84","author":"JA Hey","year":"2024","unstructured":"Hey JA, Yu JY, Abushakra S, Schaefer JF, Power A, Kesslak P, et al. Analysis of cerebrospinal fluid, plasma beta-amyloid biomarkers, and cognition from a 2-year Phase 2 trial evaluating oral ALZ-801\/Valiltramiprosate in APOE4 carriers with early Alzheimer\u2019s disease using quantitative systems pharmacology model. Drugs. 2024;84(7):825\u201339. https:\/\/doi.org\/10.1007\/s40265-024-02068-7.","journal-title":"Drugs"},{"issue":"7","key":"1482_CR9","doi-asserted-by":"publisher","first-page":"791","DOI":"10.1080\/14656566.2024.2360069","volume":"25","author":"D Lee","year":"2024","unstructured":"Lee D, Antonsdottir IM, Clark ED, Porsteinsson AP. Review of valiltramiprosate (ALZ-801) for the treatment of Alzheimer\u2019s disease: a novel small molecule with disease modifying potential. Expert Opin Pharmacother. 2024;25(7):791\u20139. https:\/\/doi.org\/10.1080\/14656566.2024.2360069.","journal-title":"Expert Opin Pharmacother"},{"issue":"3","key":"1482_CR10","doi-asserted-by":"publisher","first-page":"315","DOI":"10.1007\/s40262-017-0608-3","volume":"57","author":"JA Hey","year":"2018","unstructured":"Hey JA, Yu JY, Versavel M, Abushakra S, Kocis P, Power A, et al. Clinical pharmacokinetics and safety of ALZ-801, a novel prodrug of tramiprosate in development for the treatment of Alzheimer\u2019s disease. Clin Pharmacokinet. 2018;57(3):315\u201333. https:\/\/doi.org\/10.1007\/s40262-017-0608-3.","journal-title":"Clin Pharmacokinet"},{"issue":"6","key":"1482_CR11","doi-asserted-by":"publisher","first-page":"495","DOI":"10.1007\/s40263-017-0434-z","volume":"31","author":"P Kocis","year":"2017","unstructured":"Kocis P, Tolar M, Yu J, Sinko W, Ray S, Blennow K, et al. Elucidating the A\u03b242 anti-aggregation mechanism of action of tramiprosate in Alzheimer\u2019s disease: integrating molecular analytical methods, pharmacokinetic and clinical data. CNS Drugs. 2017;31(6):495\u2013509. https:\/\/doi.org\/10.1007\/s40263-017-0434-z.","journal-title":"CNS Drugs"},{"issue":"9","key":"1482_CR12","doi-asserted-by":"publisher","first-page":"849","DOI":"10.1007\/s40263-018-0554-0","volume":"32","author":"JA Hey","year":"2018","unstructured":"Hey JA, Kocis P, Hort J, Abushakra S, Power A, Vyhnalek M, et al. Discovery and identification of an endogenous metabolite of tramiprosate and its prodrug ALZ-801 that inhibits beta amyloid oligomer formation in the human brain. CNS Drugs. 2018;32(9):849\u201361. https:\/\/doi.org\/10.1007\/s40263-018-0554-0.","journal-title":"CNS Drugs"},{"issue":"3","key":"1482_CR13","doi-asserted-by":"publisher","first-page":"153","DOI":"10.1016\/j.jalz.2006.03.009","volume":"2","author":"PS Aisen","year":"2006","unstructured":"Aisen PS. Development of a disease-modifying treatment for Alzheimer\u2019s disease: Alzhemed. Alzheimers Dement. 2006;2(3):153\u20134. https:\/\/doi.org\/10.1016\/j.jalz.2006.03.009.","journal-title":"Alzheimers Dement"},{"issue":"10","key":"1482_CR14","doi-asserted-by":"publisher","first-page":"1757","DOI":"10.1212\/01.wnl.0000244346.08950.64","volume":"67","author":"PS Aisen","year":"2006","unstructured":"Aisen PS, Saumier D, Briand R, Laurin J, Gervais F, Tremblay P, et al. A phase II study targeting amyloid-beta with 3APS in mild-to-moderate Alzheimer disease. Neurology. 2006;67(10):1757\u201363. https:\/\/doi.org\/10.1212\/01.wnl.0000244346.08950.64.","journal-title":"Neurology"},{"issue":"4","key":"1482_CR15","doi-asserted-by":"publisher","first-page":"473","DOI":"10.2174\/156720507781788882","volume":"4","author":"PS Aisen","year":"2007","unstructured":"Aisen PS, Gauthier S, Vellas B, Briand R, Saumier D, Laurin J, et al. Alzhemed: a potential treatment for Alzheimer\u2019s disease. Curr Alzheimer Res. 2007;4(4):473\u20138. https:\/\/doi.org\/10.2174\/156720507781788882.","journal-title":"Curr Alzheimer Res"},{"issue":"4","key":"1482_CR16","doi-asserted-by":"publisher","first-page":"537","DOI":"10.1016\/j.neurobiolaging.2006.02.015","volume":"28","author":"F Gervais","year":"2007","unstructured":"Gervais F, Paquette J, Morissette C, Krzywkowski P, Yu M, Azzi M, et al. Targeting soluble Abeta peptide with tramiprosate for the treatment of brain amyloidosis. Neurobiol Aging. 2007;28(4):537\u201347. https:\/\/doi.org\/10.1016\/j.neurobiolaging.2006.02.015.","journal-title":"Neurobiol Aging"},{"issue":"11","key":"1482_CR17","doi-asserted-by":"publisher","first-page":"2303","DOI":"10.1002\/jnr.22393","volume":"88","author":"T Ariga","year":"2010","unstructured":"Ariga T, Miyatake T, Yu RK. Role of proteoglycans and glycosaminoglycans in the pathogenesis of Alzheimer\u2019s disease and related disorders: amyloidogenesis and therapeutic strategies\u2014a review. J Neurosci Res. 2010;88(11):2303\u201315. https:\/\/doi.org\/10.1002\/jnr.22393.","journal-title":"J Neurosci Res"},{"issue":"9","key":"1482_CR18","doi-asserted-by":"publisher","first-page":"1506","DOI":"10.1016\/j.jasms.2010.05.007","volume":"21","author":"E Martineau","year":"2010","unstructured":"Martineau E, de Guzman JM, Rodionova L, Kong X, Mayer PM, Aman AM. Investigation of the noncovalent interactions between anti-amyloid agents and amyloid beta peptides by ESI-MS. J Am Soc Mass Spectrom. 2010;21(9):1506\u201314. https:\/\/doi.org\/10.1016\/j.jasms.2010.05.007.","journal-title":"J Am Soc Mass Spectrom"},{"issue":"6","key":"1482_CR19","doi-asserted-by":"publisher","first-page":"580","DOI":"10.3275\/8585","volume":"24","author":"C Caltagirone","year":"2012","unstructured":"Caltagirone C, Ferrannini L, Marchionni N, Nappi G, Scapagnini G, Trabucchi M. The potential protective effect of tramiprosate (homotaurine) against Alzheimer\u2019s disease: a review. Aging Clin Exp Res. 2012;24(6):580\u20137. https:\/\/doi.org\/10.3275\/8585.","journal-title":"Aging Clin Exp Res"},{"issue":"1","key":"1482_CR20","doi-asserted-by":"publisher","first-page":"73","DOI":"10.1038\/nchem.2129","volume":"7","author":"LM Young","year":"2015","unstructured":"Young LM, Saunders JC, Mahood RA, Revill CH, Foster RJ, Tu LH, et al. Screening and classifying small-molecule inhibitors of amyloid formation using ion mobility spectrometry-mass spectrometry. Nat Chem. 2015;7(1):73\u201381. https:\/\/doi.org\/10.1038\/nchem.2129.","journal-title":"Nat Chem"},{"issue":"10","key":"1482_CR21","doi-asserted-by":"publisher","first-page":"5169","DOI":"10.1021\/acs.jctc.9b00599","volume":"15","author":"C Liang","year":"2019","unstructured":"Liang C, Savinov SN, Fejzo J, Eyles SJ, Chen J. Modulation of amyloid-\u03b242 conformation by small molecules through nonspecific binding. J Chem Theory Comput. 2019;15(10):5169\u201374. https:\/\/doi.org\/10.1021\/acs.jctc.9b00599.","journal-title":"J Chem Theory Comput"},{"issue":"6","key":"1482_CR22","doi-asserted-by":"publisher","first-page":"2228","DOI":"10.1021\/jacsau.4c00182","volume":"4","author":"SM Marques","year":"2024","unstructured":"Marques SM, Kouba P, Legrand A, Sedlar J, Disson L, Planas-Iglesias J, et al. CoVAMPnet: comparative Markov state analysis for studying effects of drug candidates on disordered biomolecules. JACS Au. 2024;4(6):2228\u201345. https:\/\/doi.org\/10.1021\/jacsau.4c00182.","journal-title":"JACS Au."},{"issue":"12","key":"1482_CR23","doi-asserted-by":"publisher","first-page":"6355","DOI":"10.3390\/ijms22126355","volume":"22","author":"M Tolar","year":"2021","unstructured":"Tolar M, Hey J, Power A, Abushakra S. Neurotoxic soluble amyloid oligomers drive Alzheimer\u2019s pathogenesis and represent a clinically validated target for slowing disease progression. Int J Mol Sci. 2021;22(12):6355. https:\/\/doi.org\/10.3390\/ijms22126355.","journal-title":"Int J Mol Sci"},{"issue":"5","key":"1482_CR24","doi-asserted-by":"publisher","first-page":"2727","DOI":"10.3390\/ijms25052727","volume":"25","author":"M Tolar","year":"2024","unstructured":"Tolar M, Hey JA, Power A, Abushakra S. The single toxin origin of Alzheimer\u2019s disease and other neurodegenerative disorders enables targeted approach to treatment and prevention. Int J Mol Sci. 2024;25(5):2727. https:\/\/doi.org\/10.3390\/ijms25052727.","journal-title":"Int J Mol Sci"},{"issue":"6","key":"1482_CR25","doi-asserted-by":"publisher","first-page":"550","DOI":"10.1007\/s12603-009-0106-x","volume":"13","author":"S Gauthier","year":"2009","unstructured":"Gauthier S, Aisen PS, Ferris SH, Saumier D, Duong A, Haine D, et al. Effect of tramiprosate in patients with mild-to-moderate Alzheimer\u2019s disease: exploratory analyses of the MRI sub-group of the Alphase study. J Nutr Health Aging. 2009;13(6):550\u20137. https:\/\/doi.org\/10.1007\/s12603-009-0106-x.","journal-title":"J Nutr Health Aging"},{"issue":"9","key":"1482_CR26","doi-asserted-by":"publisher","first-page":"808","DOI":"10.1007\/s12603-009-0217-4","volume":"13","author":"D Saumier","year":"2009","unstructured":"Saumier D, Duong A, Haine D, Garceau D, Sampalis J. Domain-specific cognitive effects of tramiprosate in patients with mild to moderate Alzheimer\u2019s disease: ADAS-cog subscale results from the Alphase Study. J Nutr Health Aging. 2009;13(9):808\u201312. https:\/\/doi.org\/10.1007\/s12603-009-0217-4.","journal-title":"J Nutr Health Aging"},{"issue":"1","key":"1482_CR27","doi-asserted-by":"publisher","first-page":"102","DOI":"10.5114\/aoms.2011.20612","volume":"7","author":"PS Aisen","year":"2011","unstructured":"Aisen PS, Gauthier S, Ferris SH, Saumier D, Haine D, Garceau D, et al. Tramiprosate in mild-to-moderate Alzheimer\u2019s disease\u2014a randomized, double-blind, placebo-controlled, multi-centre study (the Alphase Study). Arch Med Sci. 2011;7(1):102\u201311. https:\/\/doi.org\/10.5114\/aoms.2011.20612.","journal-title":"Arch Med Sci"},{"issue":"4","key":"1482_CR28","doi-asserted-by":"publisher","first-page":"219","DOI":"10.14283\/jpad.2016.115","volume":"3","author":"S Abushakra","year":"2016","unstructured":"Abushakra S, Porsteinsson A, Vellas B, Cummings J, Gauthier S, Hey JA, et al. Clinical benefits of tramiprosate in alzheimer\u2019s disease are associated with higher number of APOE4 alleles: the \u201cAPOE4 gene-dose effect.\u201d J Prev Alz Dis. 2016;3(4):219\u201328. https:\/\/doi.org\/10.14283\/jpad.2016.115.","journal-title":"J Prev Alz Dis."},{"issue":"3","key":"1482_CR29","doi-asserted-by":"publisher","first-page":"149","DOI":"10.14283\/jpad.2017.26","volume":"4","author":"S Abushakra","year":"2017","unstructured":"Abushakra S, Porsteinsson A, Scheltens P, Sadowsky C, Vellas B, Cummings J, et al. Clinical effects of tramiprosate in APOE4\/4 homozygous patients with mild Alzheimer\u2019s disease suggest disease modification potential. J Prev Alzheimers Dis. 2017;4(3):149\u201356. https:\/\/doi.org\/10.14283\/jpad.2017.26.","journal-title":"J Prev Alzheimers Dis."},{"issue":"11","key":"1482_CR30","doi-asserted-by":"publisher","first-page":"1553","DOI":"10.1016\/j.jalz.2019.09.075","volume":"16","author":"M Tolar","year":"2020","unstructured":"Tolar M, Abushakra S, Sabbagh M. The path forward in Alzheimer\u2019s disease therapeutics: reevaluating the amyloid cascade hypothesis. Alzheimers Dement. 2020;16(11):1553\u201360. https:\/\/doi.org\/10.1016\/j.jalz.2019.09.075.","journal-title":"Alzheimers Dement"},{"issue":"4","key":"1482_CR31","doi-asserted-by":"publisher","first-page":"247","DOI":"10.7326\/0003-4819-145-4-200608150-00004","volume":"145","author":"AS Levey","year":"2006","unstructured":"Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, et al. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006;145(4):247\u201354. https:\/\/doi.org\/10.7326\/0003-4819-145-4-200608150-00004.","journal-title":"Ann Intern Med"},{"issue":"43","key":"1482_CR32","doi-asserted-by":"publisher","first-page":"15181","DOI":"10.1523\/JNEUROSCI.1542-12.2012","volume":"32","author":"T Hashimoto","year":"2012","unstructured":"Hashimoto T, Serrano-Pozo A, Hori Y, Adams KW, Takeda S, Banerji AO, et al. Apolipoprotein E, especially apolipoprotein E4, increases the oligomerization of amyloid beta peptide. J Neurosci. 2012;32(43):15181\u201392. https:\/\/doi.org\/10.1523\/JNEUROSCI.1542-12.2012.","journal-title":"J Neurosci"},{"issue":"3","key":"1482_CR33","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000207919","volume":"102","author":"SJ Loomis","year":"2024","unstructured":"Loomis SJ, Miller R, Castrillo-Viguera C, Umans K, Cheng W, O\u2019Gorman J, et al. Genome-wide association studies of ARIA from the aducanumab phase 3 ENGAGE and EMERGE studies. Neurology. 2024;102(3): e207919. https:\/\/doi.org\/10.1212\/WNL.0000000000207919.","journal-title":"Neurology"},{"issue":"6","key":"1482_CR34","doi-asserted-by":"publisher","first-page":"595","DOI":"10.15252\/emmm.201606210","volume":"8","author":"DJ Selkoe","year":"2016","unstructured":"Selkoe DJ, Hardy J. The amyloid hypothesis of Alzheimer\u2019s disease at 25 years. EMBO Mol Med. 2016;8(6):595\u2013608. https:\/\/doi.org\/10.15252\/emmm.201606210.","journal-title":"EMBO Mol Med"},{"key":"1482_CR35","doi-asserted-by":"publisher","first-page":"135","DOI":"10.1186\/s40478-014-0135-5","volume":"2","author":"GP Morris","year":"2014","unstructured":"Morris GP, Clark IA, Vissel B. Inconsistencies and controversies surrounding the amyloid hypothesis of Alzheimer\u2019s disease. Acta Neuropathol Commun. 2014;2:135. https:\/\/doi.org\/10.1186\/s40478-014-0135-5.","journal-title":"Acta Neuropathol Commun"},{"issue":"1","key":"1482_CR36","doi-asserted-by":"publisher","first-page":"261","DOI":"10.3233\/JAD-142862","volume":"46","author":"SK Herukka","year":"2015","unstructured":"Herukka SK, Rummukainen J, Ihalainen J, von Und Zu Fraunberg M, Koivisto AM, Nerg O, et al. Amyloid-\u03b2 and Tau dynamics in human brain interstitial fluid in patients with suspected normal pressure hydrocephalus. J Alzheimers Dis. 2015;46(1):261\u20139. https:\/\/doi.org\/10.3233\/JAD-142862.","journal-title":"J Alzheimers Dis"},{"issue":"5893","key":"1482_CR37","doi-asserted-by":"publisher","first-page":"1221","DOI":"10.1126\/science.1161591","volume":"321","author":"DL Brody","year":"2008","unstructured":"Brody DL, Magnoni S, Schwetye KE, Spinner ML, Esparza TJ, Stocchetti N, et al. Amyloid-beta dynamics correlate with neurological status in the injured human brain. Science. 2008;321(5893):1221\u20134. https:\/\/doi.org\/10.1126\/science.1161591.","journal-title":"Science"},{"issue":"4","key":"1482_CR38","doi-asserted-by":"publisher","first-page":"403","DOI":"10.1002\/ana.21610","volume":"65","author":"LM Shaw","year":"2009","unstructured":"Shaw LM, Vanderstichele H, Knapik-Czajka M, Clark CM, Aisen PS, Petersen RC, et al. Cerebrospinal fluid biomarker signature in Alzheimer\u2019s disease neuroimaging initiative subjects. Ann Neurol. 2009;65(4):403\u201313. https:\/\/doi.org\/10.1002\/ana.21610.","journal-title":"Ann Neurol"},{"issue":"3","key":"1482_CR39","doi-asserted-by":"publisher","first-page":"853","DOI":"10.1016\/s0002-9440(10)65184-x","volume":"155","author":"LF Lue","year":"1999","unstructured":"Lue LF, Kuo YM, Roher AE, Brachova L, Shen Y, Sue L, et al. Soluble amyloid beta peptide concentration as a predictor of synaptic change in Alzheimer\u2019s disease. Am J Pathol. 1999;155(3):853\u201362. https:\/\/doi.org\/10.1016\/s0002-9440(10)65184-x.","journal-title":"Am J Pathol"}],"container-title":["Clinical Pharmacokinetics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40262-025-01482-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40262-025-01482-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40262-025-01482-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,20]],"date-time":"2025-03-20T09:39:34Z","timestamp":1742463574000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40262-025-01482-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,5]]},"references-count":39,"alternative-id":["1482"],"URL":"https:\/\/doi.org\/10.1007\/s40262-025-01482-8","relation":{},"ISSN":["0312-5963","1179-1926"],"issn-type":[{"value":"0312-5963","type":"print"},{"value":"1179-1926","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,5]]},"assertion":[{"value":"29 January 2025","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 February 2025","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The clinical study and analyses in this report were supported by Alzheon, Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"John A. Hey, Jeremy Y. Yu, Susan Abushakra, Jean F. Schaefer, Aidan Power, Patrick Kesslak, Jijo Paul and Martin Tolar are employees of Alzheon, Inc. All authors own Alzheon stocks and\/or stock options.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The protocol was approved by the assigned Ethics Committees (EC) in the Netherlands and in Czech Republic and by the institutional EC in the Czech Republic. These include the Medical-Ethical Review Committee (METC),\u00a012 October 2020; Ethics Committee of the Fakultn\u00ed nemocnice Brno, 14 October 2020; Ethics Committee of the Fakultn\u00ed nemocnice v Motole, 09 September 2020; Ethics Committee of the Fakultn\u00ed nemocnice u sv Anny v Brne, 09 September 2020; and Etick\u00e1 Komise Vestra Clinics, 17 September 2020.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All subjects and their partners, caregivers or legal representatives signed informed consent before participation in the study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"All subjects and their partners, caregivers or legal representatives provided consent that the data are publishable before participation in the study.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The data and material contained in this publication are proprietary to Alzheon Inc.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"JAH wrote the article in collaboration with JYY and JFS; SA, JAH, AP, PK, JP and MT were involved in the design and conduct of the ALZ-801-201 ADBM study. All authors have read and approved the final submitted manuscript and agree to be accountable for the work.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}