US 11,726,099 B2
Biomarker for mental disorders including cognitive disorders, and method using said biomarker to detect mental disorders including cognitive disorders
Kazuhiko Uchida, Tsukuba (JP); Takashi Ishi, Tsukuba (JP); Kohji Meno, Tsukuba (JP); and Hideaki Suzuki, Tsukuba (JP)
Assigned to MCBI INC., Tsukuba (JP)
Filed by MCBI INC., Tsukuba (JP)
Filed on Aug. 13, 2019, as Appl. No. 16/539,829.
Application 14/263,645 is a division of application No. 13/321,442, granted, now 8,748,574, issued on Jun. 10, 2014, previously published as PCT/JP2010/003295, filed on May 17, 2010.
Application 16/539,829 is a continuation of application No. 14/263,645, filed on Apr. 28, 2014, abandoned.
Prior Publication US 2020/0057079 A1, Feb. 20, 2020
Int. Cl. G01N 33/68 (2006.01); C07K 14/47 (2006.01)
CPC G01N 33/6896 (2013.01) [C07K 14/47 (2013.01); G01N 2333/705 (2013.01); G01N 2333/974 (2013.01); G01N 2560/00 (2013.01); G01N 2800/2814 (2013.01); G01N 2800/2828 (2013.01)] 3 Claims
 
1. A method for detecting a biomarker for mild cognitive impairment or Alzheimer's disease in a human subject at a preclinical stage, comprising:
(a) obtaining a serum sample from the human subject;
(b) measuring at least one biomarker in the serum sample, using a detection method selected from the group consisting of two-dimensional liquid chromatography (2D-LC)-MALDI TOF-MS and LC-MS/MS, wherein the serum sample of said (b) is an acid-treated sample or an ultrafiltered sample after acid-treatment,
wherein the at least one biomarker is at least one peptide selected from the group consisting of:
prothrombin precursor derived peptide THRB(R−) consisting of the amino acid sequence of SEQ ID NO: 4, and
prothrombin precursor-derived peptide THRB(R+) consisting of the amino acid sequence of SEQ ID NO: 5; and
(c) diagnosing the human subject with a mild cognitive impairment or Alzheimer's disease based on the level of the at least one biomarker, if:
(i) the peptide having the amino acid sequence of SEQ ID NO:4 is absent or decreased in the serum sample, as compared to the amount of the peptide having the amino acid sequence of SEQ ID NO:4 in biological material of subjects not suffering from mild cognitive impairment or Alzheimer's disease; and/or
(ii) the peptide having the amino acid sequence of SEQ ID NO:5 is present or increased in the serum sample, as compared to the amount of the peptide having the amino acid sequence of SEQ ID NO:5 in biological material of subjects not suffering from mild cognitive impairment or Alzheimer's disease.