US2004253643A1PendingUtilityA1

Methods for aiding in the diagnosis of Alzheimer's disease by measuring amyloid-beta peptide (x->41) and tau

66
Priority: Nov 14, 1994Filed: Jun 25, 2004Published: Dec 16, 2004
Est. expiryNov 14, 2014(expired)· nominal 20-yr term from priority
Inventors:Peter A. SeubertCarmen Vigo-PelfreyDale B. SchenkRobin Barbour
C07K 16/18C07K 14/4711G01N 33/6896G01N 2333/4709G01N 2500/00G01N 2800/2821Y10S436/811
66
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Claims

Abstract

This invention provides methods useful in aiding in the diagnosis of Alzheimer's disease. The methods involve measuring the amount of amyloid-β peptide (x-≧41) in the cerebrospinal fluid of a patient. High levels of the peptide generally are inconsistent with a diagnosis of Alzheimer's. Low levels of the peptide are consistent with the disease and, with other tests, can provide a positive diagnosis. Other methods involve measuring the amounts of both Aβ(x-≧41) and tau. Low levels of Aβ(x-≧41) and high levels of tau are a positive indicator of Alzheimer's disease, while high levels of Aβ(x-≧41) and low levels of tau are a negative indication of Alzheimer's disease.

Claims

exact text as granted — not AI-modified
1 - 41 . (canceled).  
     
     
         42 . A method for diagnosing probable Alzheimer's disease in a patient, the method comprising: 
 measuring the amount of one or more soluble amyloid-β peptide (x-≧41) (“Aβ(x-≧41)”) in a cerebrospinal fluid sample of the patient;    comparing the measured amount of the soluble Aβ(x-≧41) with a predetermined indicator value of the Aβ(x-≧41);    measuring the amount of tau in a cerebrospinal fluid sample of the patient;    comparing the measured amount of tau with a predetermined indicator value of tau; and    assessing patient status based on a difference between the measured amounts and predetermined indicator values, wherein a measured amount at or below the Aβ(x-≧41) indicator value and at or above the tau indicator value provides a positive indication in the diagnosis of probable Alzheimer's disease, and wherein a measured amount above the Aβ(x-≧41) indicator value and below the tau indicator value provides a negative indication in the diagnosis of probable Alzheimer's disease.    
     
     
         43 . The method of  claim 42  wherein the amount of the soluble Aβ(x-≧41) is measured by: 
 capturing the soluble Aβ(x-≧41) from the sample on a solid phase with a first antibody or antibody fragment specific for an epitope within a junction region of Aβ disposed between amino acids 13-26; and  
 detecting capture of the soluble Aβ(x-≧41) using a second antibody or antibody fragment specific for Aβ(x-≧41).  
 
     
     
         44 . The method of  claim 42  wherein the amount of the soluble Aβ(x-≧41) is measured by: 
 capturing the soluble Aβ(x-≧41) from the sample on a solid phase with a first antibody or antibody fragment specific for Aβ(x-≧41); and  
 detecting capture of the soluble Aβ(x-≧41) using a second antibody or antibody fragment that recognizes Aβ.  
 
     
     
         45 . The method of  claim 42  wherein the amount of the soluble Aβ(x-≧41) is measured by: 
 capturing the soluble Aβ(x-≧41) from the sample on a solid phase with a first antibody or antibody fragment specific for Aβ; and  
 detecting capture of the soluble Aβ(x-≧41) using a second antibody or antibody fragment specific for Aβ(x-≧41).  
 
     
     
         46 . The method of  claim 42  wherein Aβ(x-≧41) is Aβ(x-42).  
     
     
         47 . The method of  claim 43  wherein the detecting step comprises detecting binding between the second antibody or antibody fragment and Aβ(x-≧41) using a third labeled antibody or antibody fragment that recognizes the second antibody or antibody fragment but not the first antibody or antibody fragment.  
     
     
         48 . The method of  claim 43  wherein the first antibody or antibody fragment has the specificity of an antibody raised against Aβ 13-28 .  
     
     
         49 . The method of  claim 43  wherein the second antibody or antibody fragment has the specificity of an antibody raised against amino acids 33-42 of Aβ.  
     
     
         50 . The method of  claim 44  wherein the detecting step comprises detecting binding between the second antibody or antibody fragment and Aβ(x-≧41) using a third labeled antibody or antibody fragment that recognizes the second antibody or antibody fragment but not the first antibody or antibody fragment.  
     
     
         51 . The method of  claim 44  wherein the first antibody or antibody fragment has the specificity of an antibody raised against amino acids 33-42 of Aβ.  
     
     
         52 . The method of  claim 44  wherein the second antibody or antibody fragment is specific for an epitope within a junction region of Aβ disposed between amino acids 13-26.  
     
     
         53 . The method of  claim 45  wherein the detecting step comprises detecting binding between the second antibody or antibody fragment and Aβ(x-≧41) using a third labeled antibody or antibody fragment that recognizes the second antibody or antibody fragment but not the first antibody or antibody fragment.  
     
     
         54 . The method of  claim 45  wherein the second antibody or antibody fragment has the specificity of an antibody raised against amino acids 33-42 of Aβ.  
     
     
         55 . The method of  claim 47  wherein the label is an enzymatic label.  
     
     
         56 . The method of  claim 49  wherein the first antibody or antibody fragment has the specificity of an antibody raised against Aβ 13-28 .  
     
     
         57 . The method of  claim 50  wherein the label is an enzymatic label.  
     
     
         58 . The method of  claim 52  wherein the second antibody or antibody fragment has the specificity of an antibody raised against Aβ 13-28 .  
     
     
         59 . The method of  claim 53  wherein the label is an enzymatic label.  
     
     
         60 . A kit comprising: 
 a first antibody or antibody fragment specific for Aβ(x-≧41) that does not cross-react with Aβ(x-≦40) and a second antibody or antibody fragment specific for tau.    
     
     
         61 . The kit of  claim 60  wherein the first antibody or antibody fragment has the specificity of an antibody raised against amino acids 33-42 of Aβ.  
     
     
         62 . The kit of  claim 60  further comprising a third antibody or antibody fragment specific for Aβ.  
     
     
         63 . The kit of  claim 60  wherein Aβ(x-≧41) is Aβ(x-42).  
     
     
         64 . The kit of  claim 60  wherein the first antibody and second antibody are whole immunoglobulins.  
     
     
         65 . The kit of  claim 60  further comprising a third antibody or antibody fragment that is labeled and that is specific for tau.  
     
     
         66 . The kit of  claim 62  wherein the third antibody or antibody fragment is specific for an epitope within a junction region of Aβ disposed between amino acids 13-26.  
     
     
         67 . The kit of  claim 62  further comprising a fourth labeled antibody or antibody fragment that recognizes the first antibody or antibody fragment but not the third antibody or antibody fragment.  
     
     
         68 . The kit of  claim 62  further comprising a fourth labeled antibody or antibody fragment that recognizes the third antibody or antibody fragment but not the first antibody or antibody fragment.  
     
     
         69 . The kit of  claim 66  wherein the third antibody or antibody fragment has the specificity of an antibody raised against Aβ 13-28 .  
     
     
         70 . The kit of  claim 67  wherein the label is an enzymatic label.  
     
     
         71 . The kit of  claim 68  wherein the label is an enzymatic label.  
     
     
         72 . The method of  claim 51  wherein the second antibody or antibody fragment recognizes an N-terminal region of Aβ.  
     
     
         73 . The method of  claim 54  wherein the first antibody or antibody fragment recognizes an N-terminal region of Aβ.  
     
     
         74 . The kit of  claim 62  wherein the third antibody or antibody fragment recognizes an N-terminal region of Aβ.  
     
     
         75 . The method of  claim 72  wherein the second antibody or antibody fragment recognizes an epitope within amino acids 1-16 of Aβ.  
     
     
         76 . The method of  claim 73  wherein the first antibody or antibody fragment recognizes an epitope within amino acids 1-16 of Aβ.  
     
     
         77 . The kit of  claim 74  wherein the third antibody or antibody fragment recognizes an epitope within amino acids 1-16 of Aβ.

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