Title:
METHOD FOR ASSISTING WITH DIAGNOSIS OF ALZHEIMER'S DISEASE OR MILD COGNITIVE IMPAIRMENT, BIOMARKER, REAGENT KIT, AND DEVICE
Document Type and Number:
WIPO Patent Application WO/2021/107154
Kind Code:
A1
Abstract:
The present invention addresses the problem of providing a method for easily assisting with the diagnosis of Alzheimer's disease or mild cognitive impairment, a biomarker, a reagent kit, and a device. The present invention relates to a method for assisting with the diagnosis of Alzheimer's disease, said method including using an amount of phosphatidylserine- and tetraspanin-containing extracellular vesicles as an index to determine whether a subject has Alzheimer's disease. The present invention also relates to a method for assisting with the diagnosis of Alzheimer's disease or mild cognitive impairment, said method including using a ratio of the amount of phosphatidylserine- and tetraspanin-containing extracellular vesicles to the amount of tetraspanin-containing extracellular vesicles as an index to determine whether a subject has Alzheimer's disease or mild cognitive impairment. The present invention further relates to a biomarker, a reagent kit, and a device.
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Inventors:
NISHIBU TAKAHIRO (JP)
IMAWAKA NAOKO (JP)
HIRAYASU KAZUNARI (JP)
UKEKAWA RYO (JP)
SASAMOTO KODAI (JP)
ONODERA SATOSHI (JP)
IMAWAKA NAOKO (JP)
HIRAYASU KAZUNARI (JP)
UKEKAWA RYO (JP)
SASAMOTO KODAI (JP)
ONODERA SATOSHI (JP)
Application Number:
PCT/JP2020/044399
Publication Date:
June 03, 2021
Filing Date:
November 27, 2020
Export Citation:
Assignee:
FUJIFILM WAKO PURE CHEMICAL CORP (JP)
FUJIFILM WAKO SHIBAYAGI CORP (JP)
FUJIFILM WAKO SHIBAYAGI CORP (JP)
International Classes:
G01N33/92
Domestic Patent References:
| WO2019058303A1 | 2019-03-28 | |||
| WO2013054534A1 | 2013-04-18 | |||
| WO2019009985A1 | 2019-01-10 | |||
| WO2016088689A1 | 2016-06-09 | |||
| WO2016088689A1 | 2016-06-09 |
Foreign References:
| JP2016161480A | 2016-09-05 | |||
| JP2016535283A | 2016-11-10 | |||
| JP2012508577A | 2012-04-12 | |||
| US20190025330A1 | 2019-01-24 | |||
| JP2016550673A | 2014-10-24 | |||
| JP2017520760A | 2017-07-27 |
Other References:
SHIMODA ASAKO, SHIN-ICHI SAWADA, KAZUNARI AKIYOSHI: "Characterization and Functional Modification of Extracellular Vesicles", JAPAN DRUG DELIVERY SYSTEM , vol. 29, no. 2, 25 March 2014 (2014-03-25), Japan , pages 108 - 115, XP055933456, ISSN: 0913-5006, DOI: 10.2745/dds.29.108
WATARU NAKAI; TAKESHI YOSHIDA; DIEGO DIEZ; YUJI MIYATAKE; TAKAHIRO NISHIBU; NAOKO IMAWAKA; KEN NARUSE; YOSHIFUSA SADAMURA; RIKINAR: "A navel affinity-based method for the isolation of highly purified extracellular vesicles", SCIENTIFIC REPORTS,, vol. 6, 23 September 2016 (2016-09-23), pages 33935, XP055566011
AGOSTA, FEDERICA ET AL.: "Myeloid microvesicles in cerebrospinal fluid are associated with myelin damage and neuronal loss in mild cognitive impairment and Alzheimer disease", ANNALS OF NEUROLOGY, vol. 76, no. 6, 2014, pages 813 - 825, XP055278143, DOI: 10.1002/ana.24235
PULLIAM, LYNN ET AL.: "Plasma neuronal exosomes serve as biomarkers of cognitive impairment in HIV infection and Alzheimer's disease", J NEUROVIROL, vol. 25, no. 5, 4 January 2019 (2019-01-04), pages 702 - 709, XP036925336, DOI: 10.1007/s13365-018-0695-4
CHARISSE, WINSTON N. ET AL.: "Prediction of conversion from mild cognitive impairment to dementia with neuronally derived blood exosome protein profile", ALZHEIMERS DEMENT, vol. 3, 7 May 2016 (2016-05-07), Amst, pages 63 - 72, XP055569184, DOI: 10.1016/j.dadm.2016.04.001
IGETA, YUKIFUSA : "Department of integrated diagnostics for elderly Dementia-Related Diseases: Search for predisposing factors and clinical biomarkers by exosome analysis of Alzheimer type dementia", ANNUAL REPORT OF OKINAKA MEMORIAL INSTITUTE FOR MEDICAL RESEARCH, vol. 45, 30 April 2019 (2019-04-30), pages 128 - 129, XP009537076
GOUWENS LISA K., ISMAIL MUDAR S., ROGERS VICTORIA A., ZELLER NATHAN T., GARRAD EVAN C., AMTASHAR FATIMA S., MAKONI NYASHA J., OSBO: "Abeta42 Protofibrils Interact with and Are Trafficked through Microglial-Derived Microvesicles", ACS CHEMICAL NEUROSCIENCE, vol. 9, no. 6, 15 March 2018 (2018-03-15), pages 1416 - 1425, XP055832622
CAI, ZHIYOU ET AL.: "Exosomes: a novel therapeutic target for Alzheimer's disease?", NEURAL REGEN RES, vol. 13, no. 5, May 2018 (2018-05-01), pages 930 - 935, XP055825313, DOI: 10.4103/1673-5374.232490
DELEO, ANNINA M. ET AL.: "Extracellular Vesicle Biology in Alzheimer's Disease and Related Tauopathy", J NEUROIMMUNE PHARMACOL, vol. 13, no. 3, 28 November 2017 (2017-11-28), pages 292 - 308, XP036563929, DOI: 10.1007/s11481-017-9768-z
ZHOU, JIE ET AL.: "A sensitive detection assay based on signal amplification technology for Alzheimer's disease's early biomarker in exosome", ANAL CHIM ACTA, vol. 1022, 20 March 2018 (2018-03-20), pages 124 - 130, XP085392355, DOI: 10.1016/j.aca.2018.03.016
LI, TAORAN ET AL.: "Extracellular vesicles as an emerging tool for the early detection of Alzheimer's disease", MECHANISMS OF AGEING AND DEVELOPMENT, vol. 184, 1 November 2019 (2019-11-01), pages 111175, XP085909622, DOI: 10.1016/j.mad.2019.111175
DINKINS, MICHAEL B. ET AL.: "Exosome reduction in vivo is associated with lower amyloid plaque load in the 5XFAD mouse model of Alzheimer's disease", NEUROBIOLOGY OF AGING, vol. 35, no. 8, 15 February 2014 (2014-02-15), pages 1792 - 1800, XP028654941, DOI: 10.1016/j.neurobiolaging.2014.02.012
KIMURA, NOBUYUKI: "Exosomes that carry human birth, aging, and diseases: Relationship between exosome involvement and aging in neurodegenerative diseases", EXPERIMENTAL MEDICINE, vol. 29, no. 3, 1 February 2011 (2011-02-01), JP , pages 404 - 409, XP009536878, ISSN: 0288-5514
AHARON, ANAT ET AL.: "Extracellular Vesicles of Alzheimer's Disease Patients as a Biomarker for Disease Progression", MOLECULAR NEUROBIOLOG, vol. 57, no. 10, 17 July 2020 (2020-07-17), pages 4156 - 4169, XP037235355, DOI: 10.1007/s12035-020-02013-1
SUN R., WANG H., SHI Y., GAO D., SUN Z., CHEN Z., JIANG H., ZHANG J.: "A Pilot Study of Urinary Exosomes in Alzheimer's Disease", NEURODEGENERATIVE DISEASES, vol. 19, no. 5-6, 6 May 2020 (2020-05-06), CH , pages 184 - 191, XP009536871, ISSN: 1660-2854, DOI: 10.1159/000505851
C.N. WINSTON ET AL., ALZHEIMER'S & DEMENTIA: DIAGNOSIS, ASSESSMENT & DISEASE MONITORING, vol. 3, 2016, pages 63 - 72
MUSTAPIC M ET AL., FRONT. NEUROSCI., vol. 11, 2017, pages 278
NATURE REVIEWS IMMUNOLOGY, vol. 9, August 2009 (2009-08-01), pages 581 - 593
NAOTO AOKI ET AL., STUDY OF OBESITY, vol. 13, no. 2, 2007
"Immunoassay", 2014, KODANSHA LTD.
See also references of EP 4067906A4
WATARU NAKAI; TAKESHI YOSHIDA; DIEGO DIEZ; YUJI MIYATAKE; TAKAHIRO NISHIBU; NAOKO IMAWAKA; KEN NARUSE; YOSHIFUSA SADAMURA; RIKINAR: "A navel affinity-based method for the isolation of highly purified extracellular vesicles", SCIENTIFIC REPORTS,, vol. 6, 23 September 2016 (2016-09-23), pages 33935, XP055566011
AGOSTA, FEDERICA ET AL.: "Myeloid microvesicles in cerebrospinal fluid are associated with myelin damage and neuronal loss in mild cognitive impairment and Alzheimer disease", ANNALS OF NEUROLOGY, vol. 76, no. 6, 2014, pages 813 - 825, XP055278143, DOI: 10.1002/ana.24235
PULLIAM, LYNN ET AL.: "Plasma neuronal exosomes serve as biomarkers of cognitive impairment in HIV infection and Alzheimer's disease", J NEUROVIROL, vol. 25, no. 5, 4 January 2019 (2019-01-04), pages 702 - 709, XP036925336, DOI: 10.1007/s13365-018-0695-4
CHARISSE, WINSTON N. ET AL.: "Prediction of conversion from mild cognitive impairment to dementia with neuronally derived blood exosome protein profile", ALZHEIMERS DEMENT, vol. 3, 7 May 2016 (2016-05-07), Amst, pages 63 - 72, XP055569184, DOI: 10.1016/j.dadm.2016.04.001
IGETA, YUKIFUSA : "Department of integrated diagnostics for elderly Dementia-Related Diseases: Search for predisposing factors and clinical biomarkers by exosome analysis of Alzheimer type dementia", ANNUAL REPORT OF OKINAKA MEMORIAL INSTITUTE FOR MEDICAL RESEARCH, vol. 45, 30 April 2019 (2019-04-30), pages 128 - 129, XP009537076
GOUWENS LISA K., ISMAIL MUDAR S., ROGERS VICTORIA A., ZELLER NATHAN T., GARRAD EVAN C., AMTASHAR FATIMA S., MAKONI NYASHA J., OSBO: "Abeta42 Protofibrils Interact with and Are Trafficked through Microglial-Derived Microvesicles", ACS CHEMICAL NEUROSCIENCE, vol. 9, no. 6, 15 March 2018 (2018-03-15), pages 1416 - 1425, XP055832622
CAI, ZHIYOU ET AL.: "Exosomes: a novel therapeutic target for Alzheimer's disease?", NEURAL REGEN RES, vol. 13, no. 5, May 2018 (2018-05-01), pages 930 - 935, XP055825313, DOI: 10.4103/1673-5374.232490
DELEO, ANNINA M. ET AL.: "Extracellular Vesicle Biology in Alzheimer's Disease and Related Tauopathy", J NEUROIMMUNE PHARMACOL, vol. 13, no. 3, 28 November 2017 (2017-11-28), pages 292 - 308, XP036563929, DOI: 10.1007/s11481-017-9768-z
ZHOU, JIE ET AL.: "A sensitive detection assay based on signal amplification technology for Alzheimer's disease's early biomarker in exosome", ANAL CHIM ACTA, vol. 1022, 20 March 2018 (2018-03-20), pages 124 - 130, XP085392355, DOI: 10.1016/j.aca.2018.03.016
LI, TAORAN ET AL.: "Extracellular vesicles as an emerging tool for the early detection of Alzheimer's disease", MECHANISMS OF AGEING AND DEVELOPMENT, vol. 184, 1 November 2019 (2019-11-01), pages 111175, XP085909622, DOI: 10.1016/j.mad.2019.111175
DINKINS, MICHAEL B. ET AL.: "Exosome reduction in vivo is associated with lower amyloid plaque load in the 5XFAD mouse model of Alzheimer's disease", NEUROBIOLOGY OF AGING, vol. 35, no. 8, 15 February 2014 (2014-02-15), pages 1792 - 1800, XP028654941, DOI: 10.1016/j.neurobiolaging.2014.02.012
KIMURA, NOBUYUKI: "Exosomes that carry human birth, aging, and diseases: Relationship between exosome involvement and aging in neurodegenerative diseases", EXPERIMENTAL MEDICINE, vol. 29, no. 3, 1 February 2011 (2011-02-01), JP , pages 404 - 409, XP009536878, ISSN: 0288-5514
AHARON, ANAT ET AL.: "Extracellular Vesicles of Alzheimer's Disease Patients as a Biomarker for Disease Progression", MOLECULAR NEUROBIOLOG, vol. 57, no. 10, 17 July 2020 (2020-07-17), pages 4156 - 4169, XP037235355, DOI: 10.1007/s12035-020-02013-1
SUN R., WANG H., SHI Y., GAO D., SUN Z., CHEN Z., JIANG H., ZHANG J.: "A Pilot Study of Urinary Exosomes in Alzheimer's Disease", NEURODEGENERATIVE DISEASES, vol. 19, no. 5-6, 6 May 2020 (2020-05-06), CH , pages 184 - 191, XP009536871, ISSN: 1660-2854, DOI: 10.1159/000505851
C.N. WINSTON ET AL., ALZHEIMER'S & DEMENTIA: DIAGNOSIS, ASSESSMENT & DISEASE MONITORING, vol. 3, 2016, pages 63 - 72
MUSTAPIC M ET AL., FRONT. NEUROSCI., vol. 11, 2017, pages 278
NATURE REVIEWS IMMUNOLOGY, vol. 9, August 2009 (2009-08-01), pages 581 - 593
NAOTO AOKI ET AL., STUDY OF OBESITY, vol. 13, no. 2, 2007
"Immunoassay", 2014, KODANSHA LTD.
See also references of EP 4067906A4
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