Antibody array for measuring a panel of amyloids

Abstract

Described are assay methods, modules and kits useful in the detection, treatment and/or prevention of dementia and related conditions, including but not limited to Alzheimer's disease and mild cognitive disorders.

1 .- 15 . (canceled) 
     
     
         16 . A method for diagnosing Alzheimer's-related dementia in a patient comprising:
 (a) measuring, with a multiplexed assay kit comprising an array of autoantibodies configured to measure the level of; each biomarker of a panel in a test sample obtained from the patient, the panel comprising Aβ 16, Aβ 17, Aβ 42, Aβ 40, Aβ 38, total tau, P-tau, and C-tau;   b diagnosing from said measuring step the presence, and/or progression of Alzheimer's-related dementia formation in said patient.   
     
     
         17 .- 20 . (canceled) 
     
     
         21 . The method of  claim 16  wherein said method further comprises measuring a level of an additional autoantibody to at least one supplemental biomarker in said sample, wherein said supplemental biomarker comprises one or more of the following: an Aββpeptide, tau, a fragment or isoform of an Aβ peptide or tau, or combinations thereof, and said first biomarker and said supplemental biomarker are different, and determining from said levels of autoantibody and additional autoantibody the presence, absence, and/or progression of Alzheimer's-related dementia and/or plaque formation in said patient. 
     
     
         22 . The method of  claim 21  wherein said method further comprises comparing said levels of autoantibody and additional autoantibody in said sample to levels of autoantibody and additional autoantibody in a normal control sample and diagnosing the presence, absence and/or progression of Alzheimer's-related dementia and/or plaque formation in said patient based on said comparison. 
     
     
         23 . The method of  claim 21  wherein said at least one additional biomarker comprises A-beta peptide or a fragment or isoform thereof. 
     
     
         24 . The method of  claim 23  wherein said A-beta peptide is selected from the group consisting of Aβ 42, Aβ 40, Aβ 38, Aβ 39, Aβ 37, Aβ 34, Aβ 43, Aβ 16, Aβ 17 or combinations thereof. 
     
     
         25 . The method of  claim 21 , wherein said at least one additional biomarker comprises tau or a fragment or isoform thereof. 
     
     
         26 . (canceled) 
     
     
         27 . The method of  claim 16  further comprising conducting a PET scan of said patient's brain using a radioactive diagnostic agent to estimate plaque density in said patient, and said diagnosing step further comprises diagnosing the presence, absence, and/or progression of Alzheimer's-related dementia and/or plaque formation in said patient based on said PET scan and said autoantibody levels. 
     
     
         28 . The method of  claim 27  wherein said radioactive diagnostic agent is Amyvid, Pittsburgh Compound B, or combinations thereof. 
     
     
         29 . A method for diagnosing Alzheimer's-related dementia and plaque formation in a patient comprising:
 (a) measuring, with a multiplexed assay kit comprising an array of autoantibodies configured to measure the level of each biomarker of a panel in a test sample obtained from the patient, the panel comprising Aβ 16, Aβ 17, Aβ 42, Aβ 40, Aβ 38, total tau, P-tau, and C-tau;   (b) conducting a PET scan of said patient's brain using a radioactive diagnostic agent to estimate plaque density in said patient;   (c) diagnosing from said measuring step and said estimation of plaque density the presence, and/or progression of Alzheimer's-related dementia in said patient.   
     
     
         30 . A method of detecting Alzheimer's-related dementia in a patient comprising:
 (a) measuring, with a multiplexed assay kit comprising an array of autoantibodies configured to measure the level of each biomarker of a panel in a test sample obtained from the patient, the panel comprising Aβ 16, Aβ 17, Aβ 42, Aβ 40, Aβ 38, total tau, P-tau, and C-tau;   (b) detecting from said measuring step the presence, and/or progression of Alzheimer's-related dementia in said patient.   
     
     
         31 . The method of  claim 29 , wherein said method further comprises measuring a level of an additional autoantibody to at least one supplemental biomarker in said sample, wherein said supplemental biomarker comprises one or more of the following: an Aβ peptide, a fragment or isoform of an Aβ peptide or tau, or combinations thereof, and said first biomarker and said supplemental biomarker are different, and determining from said levels of autoantibody and additional autoantibody the presence, absence, and/or progression of Alzheimer's-related dementia and/or plaque formation in said patient. 
     
     
         32 . The method of  claim 31 , wherein said method further comprises comparing said levels of autoantibody and additional autoantibody in said sample to levels of autoantibody and additional autoantibody in a normal control sample and diagnosing the presence, absence and/or progression of Alzheimer's-related dementia and/or plaque formation in said patient based on said comparison. 
     
     
         33 . The method of  claim 31 , wherein said at least one additional biomarker comprises A-beta peptide or a fragment or isoform thereof. 
     
     
         34 . The method of  claim 33 , wherein said A-beta peptide is selected from the group consisting of Aβ 39, Aβ 37, Aβ 34, Aβ 43, or combinations thereof. 
     
     
         35 . The method of  claim 31 , wherein said at least one additional biomarker comprises a fragment or isoform of tau. 
     
     
         36 . The method of  claim 29 , wherein said radioactive diagnostic agent is AMYVID® (Florbetapir), Pittsburgh Compound B, or combinations thereof. 
     
     
         37 . The method of  claim 30 , wherein said method further comprises measuring a level of an additional autoantibody to at least one supplemental biomarker in said sample, wherein said supplemental biomarker comprises one or more of the following: an Aβ peptide, a fragment or isoform of an Aβ peptide or tau, or combinations thereof, and said first biomarker and said supplemental biomarker are different, and determining from said levels of autoantibody and additional autoantibody the presence, absence, and/or progression of Alzheimer's-related dementia and/or plaque formation in said patient. 
     
     
         38 . The method of  claim 37 , wherein said method further comprises comparing said levels of autoantibody and additional autoantibody in said sample to levels of autoantibody and additional autoantibody in a normal control sample and detecting the presence, absence and/or progression of Alzheimer's-related dementia and/or plaque formation in said patient based on said comparison. 
     
     
         39 . The method of  claim 37 , wherein said at least one additional biomarker comprises A-beta peptide or a fragment or isoform thereof. 
     
     
         40 . The method of  claim 39 , wherein said A-beta peptide is selected from the group consisting of Aβ 39, Aβ 37, Aβ 34, Aβ 43, or combinations thereof. 
     
     
         41 . The method of  claim 37 , wherein said at least one additional biomarker comprises a fragment or isoform of tau. 
     
     
         42 . The method of  claim 30 , further comprising conducting a PET scan of said patient's brain using a radioactive diagnostic agent to estimate plaque density in said patient, and said detecting step further comprises detecting the presence, absence, and/or progression of Alzheimer's-related dementia and/or plaque formation in said patient based on said PET scan and said autoantibody levels. 
     
     
         43 . The method of  claim 42 , wherein said radioactive diagnostic agent is AMYVID® (Florbetapir), Pittsburgh Compound B, or combinations thereof.