US2023081393A1PendingUtilityA1

Lactoferrin for use in the diagnosis or prognosis of alzheimer's disease, or in the diagnosis of parkinson's disease

Assignee: GEROA DIAGNOSTICS S LPriority: Nov 20, 2015Filed: Jul 29, 2022Published: Mar 16, 2023
Est. expiryNov 20, 2035(~9.3 yrs left)· nominal 20-yr term from priority
G01N 33/6896G01N 2800/2821C12Q 1/68G01N 2800/2835G01N 2333/79G01N 33/68G01N 2800/50
49
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Claims

Abstract

The present invention is the protein of lactoferrin, or an encoding nucleic acid of the same, for use in the diagnosis or prognosis of Alzheimer's disease (AD). The invention is a method of diagnosis or prognosis of AD in a subject, comprising assessing the level of lactoferrin in the saliva or in a saliva sample of said subject and determining whether said level is above or below a value of 7.43 μg/ml, wherein a value below 7.43 μg/ml is indicative of AD or of the prognosis of AD. Another aspect is the protein of lactoferrin, or an encoding nucleic acid of the same, for use in the diagnosis of Parkinson's disease (PD) in a saliva sample of a subject.

Claims

exact text as granted — not AI-modified
1 .- 16 . (canceled) 
     
     
         17 . A method of detecting lactoferrin in a sample obtained from a subject having or at risk of having mild cognitive impairment (MCI) or Alzheimer's disease, the method comprising:
 detecting a level of lactoferrin protein in a sample collected from the subject by exposing the sample to sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE), and determining whether the level of lactoferrin is above or below a value of 7.43 μg/ml.   
     
     
         18 . The method of  claim 17 , wherein the subject is a mammal. 
     
     
         19 . The method of  claim 18 , wherein the mammal is a human. 
     
     
         20 . The method of  claim 17 , wherein the sample comprises a protease inhibitor. 
     
     
         21 . The method of  claim 17 , further comprising a step of analyzing the sample with mass spectrometry. 
     
     
         22 . The method of  claim 17 , wherein the sample is selected from the group consisting of: saliva, oral mucosa, oral mucous tissue, and tears. 
     
     
         23 . A method of detecting lactoferrin in a sample obtained from a subject having or at risk of having mild cognitive impairment (MCI) or Alzheimer's disease, the method comprising:
 detecting a level of lactoferrin protein in a sample collected from the subject by contacting the sample with an antibody specific for lactoferrin and detecting specific binding of the antibody and lactoferrin, and   determining the level of lactoferrin in the sample;   wherein the sample is selected from the group consisting of: saliva, oral mucosa, oral mucous tissue, and tears.   
     
     
         24 . The method of  claim 23 , wherein the subject is a mammal. 
     
     
         25 . The method of  claim 24 , wherein the mammal is a human. 
     
     
         26 . The method of  claim 23 , wherein the level of lactoferrin protein is detected using a lactoferrin human enzyme-linked immunosorbent assay (ELISA) kit. 
     
     
         27 . The method of  claim 23 , wherein the sample comprises a protease inhibitor. 
     
     
         28 . A kit for detecting lactoferrin, comprising at least one reagent for the quantification of lactoferrin in a sample derived from a subject, and enabling the comparison of the quantification of lactoferrin with a predetermined cut-off value. 
     
     
         29 . The kit of  claim 28 , wherein the at least one reagent is an antibody specific for lactoferrin. 
     
     
         30 . The kit of  claim 28 , further comprising reagents suitable for an enzyme-linked immunosorbent assay (ELISA). 
     
     
         31 . The kit of  claim 28 , wherein the sample is selected from the group consisting of:
 saliva, oral mucosa, oral mucous tissue, and tears.   
     
     
         32 . The kit of  claim 28 , wherein the subject has, is suspected of having, or is at risk of developing mild cognitive impairment or Alzheimer's disease. 
     
     
         33 . The kit of  claim 28 , wherein the predetermined cut-off is 7.43 μg/ml. 
     
     
         34 . The kit of  claim 33 , wherein a value below 7.43 μg/ml indicates the subject has or is susceptible to developing mild cognitive impairment. 
     
     
         35 . The kit of  claim 33 , wherein a value below 7.43 μg/ml indicates the subject has or is susceptible to developing Alzheimer's disease.

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