Presenting the Most Recent Data at the 12th Clinical Trials on Alzheimer\u2019s Disease (CTAD) Conference<\/em><\/span>
\n<\/span><\/p>\n

Sysmex Corporation (HQ: Kobe, Japan; Chairman and\u00a0CEO<\/span>: Hisashi Ietsugu; “Sysmex”) and Eisai Co., Ltd. (HQ: Tokyo, Japan;\u00a0CEO<\/span>: Haruo Naito; “Eisai”) are pursuing a joint project to develop a method of diagnosing Alzheimer\u2019s disease (AD) using blood, presented two posters showing the most recent data from the project. The presentations took place at the 12^{th<\/sup>\u00a0Clinical Trials on Alzheimer\u2019s Disease (CTAD) conference, from December 4 to 7, 2019, in San Diego, California. At\u00a0CTAD,<\/span>\u00a0Sysmex demonstrated on behalf of the two companies the possibility of understanding amyloid pathology in the brain from the brain-derived amyloid beta (A\u03b2) in plasma measured using its protein measurement platform, the\u00a0HISCL<\/span>\u2122 series of fully automated immunoassay analyzers.<\/p>\n}

The total number of those living with dementia across the world is projected to reach 82 million in 2030 and 152 million in 2050, with the total global societal cost of dementia stemming from direct medical and social care costs and lower productivity being estimated to reach 220 trillion yen in 2030.^{1<\/sup>\u00a0In Japan, the number of those with dementia is thought to have reached approximately 4.62 million in 2012 and is projected to grow to 7.30 million in 2025^{2<\/sup>, with the total societal cost of this disease being estimated to be equivalent to 4.1%^{3<\/sup>\u00a0of the gross domestic product (GDP) in 2025 (25.8 trillion yen^{4<\/sup>). Of these sufferers, those living with AD is thought to account for more than 60% of those living with dementia.^{2<\/sup><\/p>\n}}}}}

It is conceivable that AD is a disease that results in synaptic dysfunction and neuronal cell death due to the tau deposition in neurons triggered by A\u03b2 aggregation on the outside of neurons. These brain changes cause the cognitive impairment and psychological and behavioral symptoms, suggesting that the A\u03b2 aggregation and accumulation inside the brain is caused by AD before the presence of cognitive impairment appears, thus, it is believed that early diagnosis and early intervention is more effective in therapies targeting A\u03b2. Currently, amyloid\u00a0PET\u00a0<\/span>and the plasma A\u03b2_{1-42<\/sub>\/ A\u03b2_{1-40<\/sub>\u00a0ratio in cerebrospinal fluid (CSF) are used for detecting amyloid aggregates in the brain, but this puts significant burden on patients in terms of access, costs, and their physical wellbeing.^{5<\/sup><\/p>\n}}}

In February 2016, Sysmex and Eisai signed a comprehensive non-exclusive agreement aimed at the development of new diagnostic tests in the field of dementia. By leveraging each other\u2019s technologies and knowledge, the objective has been to discover next-generation diagnostic reagents that will enable early diagnosis of dementia, selection of the most appropriate treatment options, and regular monitoring of the effects of such treatments.<\/p>\n

At the Alzheimer\u2019s Association International Conference (AAIC) held in July 2019, Sysmex and Eisai presented their joint research on the correlation (Spearman\u2019s rank correlation coefficient (r_{s<\/sub>)^{6<\/sup>=0.502, p<0.001) between the A\u03b2_{1-42<\/sub>\/ A\u03b2_{1-40<\/sub>\u00a0ratio in\u00a0CSF\u00a0<\/span>and the A\u03b2_{1-42<\/sub>\/ A\u03b2_{1-40<\/sub>\u00a0ratio in plasma, and demonstrated that it may be possible to understand amyloid pathology in the brain by measuring the plasma A\u03b2_{1-42<\/sub>\/ A\u03b2_{1-40<\/sub>ratio. Subsequently, the two companies have examined the correlation between the plasma A\u03b2_{1-42<\/sub>\/ A\u03b2_{1-40<\/sub>\u00a0ratio and amyloid\u00a0PET.<\/span><\/p>\n}}}}}}}}}}

Sysmex and Eisai are engaged in joint development aimed at creating a simple method of diagnosing AD from a blood sample. At\u00a0CTAD,<\/span>\u00a0Sysmex demonstrated that it may be possible to understand pathological processes in the brain by measuring the plasma A\u03b2_{1-42<\/sub>\/A\u03b2_{1-40<\/sub>\u00a0ratio based on the analysis result of the plasma A\u03b2_{1-42<\/sub>\/A\u03b2_{1-40<\/sub>ratio measured with the\u00a0HISCL<\/span>\u2122 series as a prediction factor for A\u03b2\u00a0PET\u00a0<\/span>positivity. Also it was presented a technique for verifying that the\u00a0HISCL<\/span>\u2122 measuring system correctly captures A\u03b2 in plasma on that occasion.<\/p>\n}}}}

Sysmex and Eisai are working to create new diagnostic technologies for the prevention and treatment of dementia. Accordingly, the overarching aim is to contribute to the advancement of healthcare and improve the quality of life for those living with the disease and their families.
\n[Data sheet]<\/strong><\/p>\n

\n\n\n\n<\/colgroup>\n\n\n\n
Blood diagnosis\u00a0P75<\/span><\/th>\n Prediction of amyloid pathology by the plasma A\u03b2<\/em>(1-42)\/A\u03b2<\/em>(1-40) ratio measured with a fully automated immunoassay system (HISCL\u2122 series)
\nPoster presentation: December 4 (Wed.) to December 5 (Thu.)<\/th>\n<\/tr>\n
In the presentation (P75), to create a simple blood diagnostic test for\u00a0AD,\u00a0<\/span>the result of the receiver operating characteristic (ROC) analysis of the plasma A\u03b2_{1-42<\/sub>\/A\u03b2_{1-40<\/sub>\u00a0ratio, measured using the\u00a0HISCL<\/span>\u2122 series, was used as a prediction factor for A\u03b2-PET positivity. The\u00a0HISCL<\/span>\u2122 system enables an automated immune assay to be completed in 17 minutes with sample volumes as small as 10-30\u00b5L, and it was demonstrated that the A\u03b2 assay in plasma had sufficient sensitivity and high reliability. In addition, it was confirmed that the A\u03b2 assay system using the\u00a0HISCL<\/span>\u2122 series had a high correlation with IP-MS methods reported in Poster 81.<\/p>\nThe samples from 192 persons living with the disease with mild cognitive impairment (MCI) and AD associated with amyloid\u00a0PET\u00a0<\/span>results were used for investigation with the\u00a0HISCL<\/span>\u2122 series. Using the plasma A\u03b2_{1-42<\/sub>\/A\u03b2_{1-40<\/sub>ratio, amyloid\u00a0PET\u00a0<\/span>positivity can be predicted with a sensitivity of 73% and a specificity of 71% (AUC0.74), and it was confirmed that sensitivity and specificity were improved (AUC0.82) by adding factors such as age and\u00a0APOE4,\u00a0<\/span>a gene associated with a greatly increased risk of developing\u00a0AD.<\/span>\u00a0This preliminary result indicates the plasma A\u03b2_{1-42<\/sub>\/A\u03b2_{1-40<\/sub>ratio measured with the\u00a0HISCL<\/span>\u2122 series could be used as a prescreening method for amyloid\u00a0PET.<\/span>\u00a0To further assess its clinical utility, additional sample sets will be evaluated.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n}}}}
\n\n\n\n<\/colgroup>\n\n\n\nBlood diagnosis\u00a0P81<\/span><\/th>\n Clinical utility of plasma amyloid beta measurements by immunoaffinity enrichment and LC-MS\/MS
\nPoster presentation: December 4 (Wed.) to December 5 (Thu.)<\/th>\n<\/tr>\n
In the presentation (P81), the development of high-sensitivity peptide (A\u03b2_{1-42<\/sub>\u00a0and A\u03b2_{1-40<\/sub>) measurement technology using mass spectrometry was described. With this technology, it is possible to measure the peptides in a liquid sample in two hours with a small sample volume of 250\u00b5L, and it was confirmed that the amounts of A\u03b2_{1-42\u00a0<\/sub>and A\u03b2_{1-40<\/sub>\u00a0in\u00a0CSF\u00a0<\/span>and plasma could be measured. In addition to the presentation on the measurement performance (dynamic range, sensitivity, reproducibility, etc.) of this method under pure conditions, a good correlation between the\u00a0CSF<\/span>\u00a0A\u03b2_{1-42<\/sub>\/A\u03b2_{1-40<\/sub>\u00a0ratio and plasma A\u03b2_{1-42<\/sub>\/A\u03b2_{1-40<\/sub>\u00a0ratio in elderly persons with normal cognition and those living with\u00a0MCI\u00a0<\/span>and AD (44 people in total) was confirmed.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n^{1<\/sup>\u00a0World Alzheimer Report 2018
\n^{2<\/sup>\u00a0Promotion of Comprehensive Measures against Dementia, Ministry of Health, Labour and Welfare
\n^{3<\/sup>\u00a0Study on Economic Impact of Dementia in Japan, 2014 Health Labour Sciences Research Grant Annual Report
\n^{4<\/sup>\u00a0Estimated by Sysmex based on Japan\u2019s Medium-term Economic Outlook (February 2018), Daiwa Institute of Research
\n^{5<\/sup>\u00a0A\u03b2<\/em>, a peptide consisting of amino acid residues, is generated by excision from the amyloid precursor protein. A\u03b2<\/em>_{1-40<\/sub>\u00a0consists of 40 residues, is the dominant substance, and does not fluctuate significantly as AD progresses. In contrast, A\u03b2<\/em>_{1-42<\/sub>, which consists of 42 residues, has high aggregability and a reduction in A\u03b2<\/em>_{1-42<\/sub>\u00a0is detected from the early stage of\u00a0AD.<\/span>\u00a0There are individual differences in the absolute value of A\u03b2<\/em>as well as intra-individual variabilities, therefore, it has been reported that there is a high correlation between the A\u03b2<\/em>_{1-42<\/sub>\/A\u03b2<\/em>_{1-40<\/sub>\u00a0ratio in\u00a0CSF\u00a0<\/span>and amyloid\u00a0PET.<\/span>
\n^{6<\/sup>\u00a0The correlation coefficient indicates the strength of the relationship between the two sets pf data from the two quantitative data distributions. In this analysis, Spearman\u2019s rank correlation coefficient (r_{s<\/sub>), which is an index of correlation obtained from rank data, is calculated.\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"}}}}}}}}}}}}
Sysmex Corporation (HQ: Kobe, Japan; Chairman and\u00a0CEO: Hisashi Ietsugu; “Sysmex”) and Eisai Co., Ltd. (HQ: Tokyo, Japan;\u00a0CEO: Haruo Naito; “Eisai”) are pursuing a joint project to develop a method of diagnosing Alzheimer\u2019s disease (AD) using blood, presented two posters showing the most recent data from the project. The presentations took place at the 12th\u00a0Clinical Trials on Alzheimer\u2019s Disease (CTAD) conference, from December 4 to 7, 2019, in San Diego, California. At\u00a0CTAD,\u00a0Sysmex demonstrated on behalf of the two companies the possibility of understanding amyloid pathology in the brain from the brain-derived amyloid beta (A\u03b2) in plasma measured using its protein measurement platform, the\u00a0HISCL\u2122 series of fully automated immunoassay analyzers.<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[28],"tags":[],"class_list":["post-2842","post","type-post","status-publish","format-standard","hentry","category-news-en"],"_links":{"self":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/2842"}],"collection":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/comments?post=2842"}],"version-history":[{"count":2,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/2842\/revisions"}],"predecessor-version":[{"id":2844,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/2842\/revisions\/2844"}],"wp:attachment":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/media?parent=2842"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/categories?post=2842"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/tags?post=2842"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}}}}}}}}}}}