Alzheimer's diagnosis

Abstract

Evaluation of VLP-1 levels in combination with at least one of amyloid-β peptide (Aβ), hyperphosphorylated tau (pTau) or total tau (tTau) levels in samples of biological fluid improves the accuracy of diagnosis of Alzheimer's disease.

1 . A kit for diagnosing Alzheimer's disease in a subject, which comprises antibodies immunoreactive with VLP-1 and antibodies immunoreactive with at least one of Aβ1-42, p-tau and t-tau, along with reagents for detecting said immunoreaction. 
     
     
         2 . The kit of  claim 1  which comprises antibodies immunoreactive with VLP-1 and antibodies reactive Aβ1-42. 
     
     
         3 . The kit of  claim 1  which further contains antibodies immunoreactive with p-tau or with t-tau. 
     
     
         4 . The kit of  claim 3  which contains antibodies immunoreactive with p-tau and immunoreactive with t-tau. 
     
     
         5 . The kit of  claim 1  wherein the antibodies are monoclonal. 
     
     
         6 . The kit of  claim 1  which compriese reagents for ELISA or radio immunoassays. 
     
     
         7 . A method of diagnosing Alzheimer's disease in a subject which method comprises determining the level of VLP-1 in a sample of biological fluid of a human subject in combination with determining the presence or absence of an ApoE ε4 allele in said subject;
 comparing the level of said VLP-1 with the level of VLP-1 in normal controls; 
 wherein a higher level of VLP-1 in combination with the presence of an ApoE ε4 allele in said subject results in a diagnosis for said subject of Alzheimer's disease. 
 
     
     
         8 . The method of  claim 7  wherein the sample is obtained from cerebrospinal fluid. 
     
     
         9 . The method of  claim 7  wherein the sample is obtained from plasma or serum. 
     
     
         10 . A kit for diagnosing Alzheimer's disease in a subject which comprises reagents for conducting the method of  claim 7 . 
     
     
         11 . The kit of  claim 10 , which comprises antibodies immunoreactive with VLP-1 and reagents for determining the presence of an ApoE ε4 allele.