JP5005690B2 - 神経変性疾患の検出のためのinvitro方法 - Google Patents
神経変性疾患の検出のためのinvitro方法 Download PDFInfo
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Description
1.脳特異的であって、これらの疾患の神経病理学的な基本的特徴を検出すること。
2.診断感度及び特異性が少なくとも80%であること。
3.バイオマーカーの疾患特異的変化が、適切な治療手段を開始できるようにするために、できるだけ疾患の早期の段階でそれ自体明白であること(非特許文献9)。
BEINFELD M. C. (1998). Prohormone and proneuropeptide processing. Recent progress and future challenges. Endocrine 8:1-5 BELTOWSKI J., JAMROZ A. (2004). Adrenomedullin - what do we know 10 years since its discovery? Polish Journal of Pharmacology 56: 5-27 BUNTON D. C, PETRIE M. C, HILLIER C, JOHNSON F., MCMURRAY J. J.V. (2004) . The clinical relevance of adrenomedullin: a promosing profile? Pharmacology & Therapeutics 103:179-201 CHU D. Q., SMITH D.M., BRAIN S.D. (2001). Studies of the microvascular effects of adrenomedullin and related Peptides. Peptides 22:1881-1886 ELSASSER T. H., KAHL S., MARTINEZ A., MONTUENGA L. M., PIO R., CUTTITTA F. (1999). Adrenomedullin Binding Protein in the Plasma of Multiple Species: Characterization by Radioligand Blotting. Endocrinology 140(10): 4908-4911 ENDO T. (2001) . A review of the biological properties and clinical implications of adrenomedulln and proadrenomedullin N-terminal 20 peptide (PAMP) , hypotensive and vasodilating peptides. Peptides 22:1693-1711 FRANK R. A., GALASKO D., HAMPEL H., HARDY J., DE LEON M. J., MEHTA P. D.; ROGERS J., SIEMERS E., TROJANOWSKI J. Q. (2003) . Biological markers for therapeutic trials in Alzheimer' s disease. Proceedings of the biological markers working group; NIA initiative on neuroimaging in Alzheimer' s disease. Neurobiology of Aging 24: 521-536 GELDMACHER D. S. (2004). Dementia with Lewy bodies: diagnosis and clinical approach. Cleveland clinic Journal of Medicine 71:789-800 GROWDON J. H., SELKOE D. J., ROSES A., TROJANOWSKI J. Q., DAVIES P., APPEL S. et al . [Working Group Advisory Committee] . (1998) . Consensus report of the Working Group on Biological Markers of Alzheimer' s Disease. [Ronald und Nancy Reagan Institute of the Alzheimer' s Association and National Institute on Aging Working Group on Biological Biomarkers of Alzheimer' s Disease] . Neurobiology of Aging 19: 109-116 ICHIKI Y., KITAMURA K., KANGAWA K., KAWAMOTO M., MATSUO H., ETO T. (1994) . Distribution and characterization of immunoreactive adrenomedullin in human tissue and plasma. FEBS Letters 338:6-10 KIS B., ABRAHAM CS., DELI M.A., KOBAYASHI H., WADAA., NIWA M., YAMASHITA H., UETA Y. (2001). Adrenomedullin in the cerbral circulation. Peptides 22:1825-1834 KITAMURA K., KANGAWA K., ISHIYAMA Y., WASHIMINE H., ICHIKI Y., KAWAMOTO M., MINAMINO N., MATSUO H., ETO T. (1994) . Identification and hypotensive activity of proadrenomedullin N-terminal 20 peptide (PAMP) . FEBS Letters 351 (1) : 35-37 KITAMURA K., KANGAWA K., ETO T. (2002). Adrenomedullin and PAMP: Discovery, Structures, and Cardiovascular Functions. Microsc. Res . Tech. 57:3-13. MCKEITH I. G. (2002). Dementia with lewy bodies. British Journal of Psychiatry 180: 144-147 MEERAN K., O'SHEA D., UPTON P. D., SMALL C. J., GHATEI M. A., BYFIELD P. H., BLOOM S. R. (1997). Circulating adrenomedullin does not regulate systemic blood pressure but increases plasma prolactin after intravenous infusion in humans : a pharmacokinetic study. Journal of Clinical Endocrinology and Metabolism 82:95-100 MORGENTHALER N. G., STRUCK J., ALONSO C, BERGMANN A. (2005) . Measurement of mid regional proadrenomedullin (MR-proADM) in plasma with an immunoluminometric assay. (Clinical Chemistry, 2005; in press) M. GARY NICHOLLS, JOHN G. LAINBURY, LYNLEY K. LEWIS, DAVID 0. MCGREGOR, A. MARK RICHARDS, RICHARD W. TROUGHTON, TIMOTHY G. YANDLE (2001) . Bioactivity of adrenomedullin and proadrenomedullin N-terminal 20 peptide in man. Peptides 22 1745-1732. SATOH F., TAKAHASHI K., MUR-AKAMI 0., TOTSUNE K., SONE M., OHNEDA M., ABE K., MIURA Y., HAYASHI Y., SASANO H. (1995) . Adrenomedullin in human brain, adrenal glands and tumor tissues of pheochromocytoma, ganglioneuroblastoma and neuroblastoma . Journal of Clinical Endocrinolology and Metabolism 80(5) : 1750-2 SELKOE D. J. (2001). Alzheimer's disease: genes, proteins, and therapy. Physiological Reviews 81: 741-766 STROUD R. M., WALTER P. (1999). Signal sequence recognition and protein targeting. Current Opinion Structure Biology 9:754-9 STRUCK J., CHEN T., MORGENTHALER N. G., BERGMANN A. (2004) . Identification of an adrenomedullin precursor fragment in plasma of sepsis patients. Peptides 25: 1369-1372 SUGO S., MINAMINO N., KANGAWA K., MIYAMOTO K., KITAMURA K., SAKATA J., ETO T., MATSUO H. (1994). Endothelial cells actively synthesize and secrete adrenomedullin. Biochemical and Biophysical Research Communication 201 (3) :1160-6 TARKOWSKI E. (2002). Cytokines in dementias. Current Drug Targets - Inflammation and Allergy 1: 193-200 TARKOWSKI E., LILJEROTH A. M., MINTHON L., TARKOWSKI A., WALLIN A., BLENNOW K. (2003). Cerebral pattern of pro- and anti-inflammatory cytokines in dementias. Brain Research Bulletin 61: 255-260 TAYLOR M. M., SAMSON W. K. (2001). Adrenomedullin and central cardiovascular regulation. Peptides 22:1803-1807 TEUNISSEN C. E., DE VENTE J., STEINBUSCH H. W. M., DE BRUIJN C. (2002) . Biochemical markers related to Alzheimer' s dementia in serum and cerebrospinal fluid. Neurobiology of Aging 23:485-508
血漿中の中領域プロADM45−92(MR−プロADM;配列番号2)の測定を、WO 2004/090546または対応のEP 1 488 209 A1の実施例、あるいは非特許文献21または非特許文献16に実質的に記載された免疫発光サンドイッチアッセイによって実施した。
MR−プロADMの濃度についての参照値を測定するため、神経変性疾患にも、ADMまたはプロADM部分ペプチドの上昇した測定値を与えることが既知であるいずれかの他の認識可能な疾患(心臓血管疾患;重篤な感染症または炎症)にも罹患していない264名の健康なコントロール患者のEDTA血漿で測定を実施した。コントロール群については、0.33±0.07nmol/l(0.10から0.64nmol/lの範囲)のMR−プロADMの平均値が測定された。年齢群に従ったコントロール患者の評価では、38.3±13.9歳の年齢群について0.337nmol/lの平均値が得られ、69.0±4.8歳の選択年齢群については、0.392nmol/lの平均値が得られた(図1参照)。
Claims (10)
- 神経変性疾患の検出、重篤さの測定、並びにモニター及び予後のためのin vitro方法であって、生理学的に不活性なプロアドレノメデュリン部分ペプチドの存在及び/または濃度を、神経変性疾患に罹患している患者、あるいはそのような疾患に罹患する疑いのある患者の生物学的流体で測定し、前記患者の生物学的流体での測定値が、予め定められた健康なコントロールの生物学的流体での測定値よりも高い場合は、前記患者が神経変性疾患に罹患していると判断することを特徴とする方法。
- アッセイ方法が免疫検出アッセイ方法であることを特徴とする、請求項1に記載の方法。
- 完全プレプロアドレノメデュリン(配列番号1)のアミノ酸45−92を有する中領域プロアドレノメデュリン部分ペプチド(MR−プロADM;配列番号2)が、患者の血漿において測定されることを特徴とする、請求項1または2に記載の方法。
- 前記免疫検出アッセイ方法が、サンドイッチタイプの免疫アッセイであることを特徴とする、請求項2または3に記載の方法。
- 前記神経変性疾患が、アルツハイマー痴呆(AD)、レヴィー小体を有する痴呆(DLB)、前頭側頭型痴呆(FTD)、及び各種の形態の血管痴呆(VAD)から選択される初老期の痴呆であることを特徴とする、請求項1から4のいずれか一項に記載の方法。
- アルツハイマー痴呆の検出の一部として実施されることを特徴とする、請求項5に記載の方法。
- 各臨床像に関連する少なくとも一つの更なる生化学的または生理学的なパラメーター情報が同時に測定され、測定された結果が神経変性疾患の細かい検出のために評価される少なくとも二つの測定された変数のセットの形態で得られるマルチパラメーター測定の一部として実施されることを特徴とする、請求項1から6のいずれか一項に記載の方法。
- プロアドレノメデュリン部分ペプチドの測定に加えて、前記マルチパラメーター測定の一部として、炎症メディエーター、補体成分、サイトカイン、ケモカイン、血液凝固成分及び線維素溶解性因子、急性期のタンパク質、並びにフリーラジカル化合物からなる群から選択される、少なくとも一つの更なる生化学的パラメーターが測定されることを特徴とする、請求項7に記載の方法。
- 前記マルチパラメーター測定が、チップテクノロジー測定装置または免疫クロマトグラフィー測定装置によって同時の測定として実施されることを特徴とする、請求項7または8に記載の方法。
- 前記マルチパラメーター測定の複雑な測定結果の評価が、コンピュータープログラムの補助で実施されることを特徴とする、請求項7から9のいずれか一項に記載の方法。
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DE102005036094.7 | 2005-08-01 | ||
DE102005036094A DE102005036094A1 (de) | 2005-08-01 | 2005-08-01 | In vitro Verfahren zur Diagnose von neurodegenerativen Erkrankungen |
PCT/EP2006/007272 WO2007014667A1 (de) | 2005-08-01 | 2006-07-24 | In vitro verfahren zur diagnose von neurodegenerativen erkrankungen |
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JP2009503524A JP2009503524A (ja) | 2009-01-29 |
JP5005690B2 true JP5005690B2 (ja) | 2012-08-22 |
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US (1) | US7547553B2 (ja) |
EP (1) | EP1910841B1 (ja) |
JP (1) | JP5005690B2 (ja) |
AT (1) | ATE514948T1 (ja) |
DE (1) | DE102005036094A1 (ja) |
ES (1) | ES2369552T3 (ja) |
WO (1) | WO2007014667A1 (ja) |
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DE10316583A1 (de) * | 2003-04-10 | 2004-10-28 | B.R.A.H.M.S Aktiengesellschaft | Bestimmung eines midregionalen Proadrenomedullin-Teilpeptids in biologischen Flüssigkeiten zu diagnostischen Zwecken, sowie Immunoassays für die Durchführung einer solchen Bestimmung |
DE102005036094A1 (de) * | 2005-08-01 | 2007-02-08 | B.R.A.H.M.S Ag | In vitro Verfahren zur Diagnose von neurodegenerativen Erkrankungen |
US8906857B2 (en) * | 2005-12-01 | 2014-12-09 | B.R.A.H.M.S. Gmbh | Methods for the diagnosis and treatment of critically ill patients with endothelin, endothelin agonists and adrenomedullin antagonists |
CA2648382C (en) | 2006-04-04 | 2016-10-11 | Singulex, Inc. | Methods and compositions for highly sensitive analysis of markers and detection of molecules |
US7838250B1 (en) | 2006-04-04 | 2010-11-23 | Singulex, Inc. | Highly sensitive system and methods for analysis of troponin |
US9012151B2 (en) * | 2006-11-09 | 2015-04-21 | B.R.A.H.M.S. Gmbh | Methods of diagnosis and risk stratification of adverse events in post myocardial infarction patients using pro-adrenomedullin |
DE102006060112A1 (de) * | 2006-12-20 | 2008-06-26 | Brahms Aktiengesellschaft | Diagnose und Risikostratifizierung mittels dem neuen Marker CT-proADM |
DE102007009751A1 (de) | 2007-02-28 | 2008-09-04 | B.R.A.H.M.S Aktiengesellschaft | Verfahren zur selektiven Bestimmung von Procalcitonin 1-116 für diagnostische Zwecke sowie Antikörper und Kits zur Durchführung eines solchen Verfahrens |
EP2347266B9 (en) * | 2008-11-11 | 2014-02-12 | B.R.A.H.M.S GmbH | Prognosis and risk assessment in patients suffering from heart failure by determining the level of adm |
JP5678045B2 (ja) | 2009-06-08 | 2015-02-25 | シンギュレックス・インコーポレイテッド | 高感度バイオマーカーパネル |
US20130302841A1 (en) * | 2010-11-01 | 2013-11-14 | B.R.A.H.M.S Gmbh | Prognosis and risk assessment of patients with non-specific complaints |
WO2018029214A1 (en) * | 2016-08-09 | 2018-02-15 | B.R.A.H.M.S Gmbh | Histones and/or proadm as markers indicating an adverse event |
MX2020008345A (es) * | 2018-02-08 | 2020-09-25 | Sphingotec Gmbh | Adrenomedulina (adm) para el diagnostico y/o prediccion de demencia y un aglutinante de anti-adrenomedulina para usarse en la terapia o prevencion de demencia. |
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JP2774769B2 (ja) * | 1993-04-26 | 1998-07-09 | 賢治 寒川 | アドレノメデュリン |
JP2005520521A (ja) * | 2002-03-20 | 2005-07-14 | ノバルティス アクチエンゲゼルシャフト | 統合失調症の診断および処置方法 |
AU2003280117B2 (en) * | 2002-11-20 | 2009-09-10 | Newron Sweden Ab | Compounds and methods for increasing neurogenesis |
CA2511501A1 (en) * | 2002-12-24 | 2004-07-15 | Biosite Incorporated | Markers for differential diagnosis and methods of use thereof |
EP1867734A1 (en) * | 2002-12-24 | 2007-12-19 | Biosite Incorporated | Markers for differential diagnosis and methods of use thereof |
DE10316583A1 (de) | 2003-04-10 | 2004-10-28 | B.R.A.H.M.S Aktiengesellschaft | Bestimmung eines midregionalen Proadrenomedullin-Teilpeptids in biologischen Flüssigkeiten zu diagnostischen Zwecken, sowie Immunoassays für die Durchführung einer solchen Bestimmung |
DE102005036094A1 (de) * | 2005-08-01 | 2007-02-08 | B.R.A.H.M.S Ag | In vitro Verfahren zur Diagnose von neurodegenerativen Erkrankungen |
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- 2005-08-01 DE DE102005036094A patent/DE102005036094A1/de not_active Withdrawn
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- 2006-07-24 WO PCT/EP2006/007272 patent/WO2007014667A1/de active Application Filing
- 2006-07-24 JP JP2008524396A patent/JP5005690B2/ja active Active
- 2006-07-24 AT AT06762778T patent/ATE514948T1/de active
- 2006-07-24 EP EP06762778A patent/EP1910841B1/de active Active
- 2006-07-24 ES ES06762778T patent/ES2369552T3/es active Active
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ES2369552T3 (es) | 2011-12-01 |
US20080199966A1 (en) | 2008-08-21 |
ATE514948T1 (de) | 2011-07-15 |
JP2009503524A (ja) | 2009-01-29 |
DE102005036094A1 (de) | 2007-02-08 |
WO2007014667A1 (de) | 2007-02-08 |
WO2007014667A9 (de) | 2007-06-14 |
EP1910841A1 (de) | 2008-04-16 |
US7547553B2 (en) | 2009-06-16 |
EP1910841B1 (de) | 2011-06-29 |
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