Method for determining the prognosis of a patient with a neurological disease

Abstract

The present invention provides a method for the determining the prognosis for a patient diagnosed with a neurological disease. The present invention also provides a method for the identification of human subjects for placement in clinical drug trials of drugs being tested for the treatment of neurological disease and for determining a patient's future disease risk.

What is claimed is:  
     
         1 . A method of determining the prognosis for a patient already diagnosed with a non-AD neurological disease, said method comprising: 
 a) identifying a patient with said disease;    b) determining the apoE genotype or phenotype of said patient;    c) converting the data obtained in step b) into a prognosis for said patient.    
     
     
         2 . The method of  claim 1 , wherein said prognosis includes a prediction of drug efficacy, patient outcome, or a forecast of patient disease risk.  
     
     
         3 . The method of  claim 1 , wherein the method further comprises determining the BChE genotype or phenotype of said patient.  
     
     
         4 . The method of  claim 1 , wherein said method further comprises obtaining a patient profile.  
     
     
         5 . The method of  claim 4 , wherein said patient profile includes a determination of said patient's sex.  
     
     
         6 . The method of  claim 4 , wherein said patient profile includes the genotype of said patient.  
     
     
         7 . The method of  claim 4 , wherein said patient profile includes the age of said patient.  
     
     
         8 . The method of  claim 1 , wherein said patient is diagnosed with a disease or determined as being predisposed to a disease selected from the group consisting of stroke, Parkinson's disease, multiple sclerosis, multi-infarct dementia (MID), vascular dementia, cardiovascular injury, and cardiovascular accident.  
     
     
         9 . The method of  claim 1 , wherein said patient is diagnosed as having stroke or as being predisposed to sustain a stroke.  
     
     
         10 . The method of  claim 1 , wherein said patient is diagnosed as having Parkinson's disease or as being predisposed to acquire Parkinson's disease.  
     
     
         11 . The method of  claim 1 , wherein said patient is diagnosed as having multiple sclerosis or as being predisposed to acquire multiple sclerosis.  
     
     
         12 . A method for identifying a patient for participation in a clinical trail of a drug for the treatment of a neurological disease, said method compromising: 
 a) identifying a patient already diagnosed with said disease or as being predisposed to acquire or be at risk for said disease;    b) determining the apoE genotype or phenotype of said patient;    c) converting the data obtained in step b) and determining the prognosis of said patient, said prognosis including a prediction of whether the patient is a candidate for a drug trial for the treatment of a neurological disease.    
     
     
         13 . The method of  claim 12 , wherein said method further comprises determining the BChE genotype or phenotype of said patient.  
     
     
         14 . The method of  claim 12  wherein said drug is from the group comprising aspirin, antithrombotics, ticlopidine, Ticlid™, cholinomimetics, tacrine, levodopa-carbidopa, Sinernet™, interferon β-1B, or Betaseron™.  
     
     
         15 . The method of  claim 12  wherein said drug is tacrine.  
     
     
         16 . The method of  claim 12  wherein said patient is asymptomatic.  
     
     
         17 . A method of determining a prognosis of future risk of a disease for a mammal asymptomatic for said disease, said method comprising: 
 a) determining the apoE genotype or phenotype of said mammal;    b) converting the data obtained in step a) into a prognosis for said human, said prognosis including a prediction of a human's future disease risk, drug treatment efficacy for said disease, or treatment outcome.    
     
     
         18 . The method of  claim 17 , wherein said mammal is a human.  
     
     
         19 . The method of  claim 17 , wherein the method further comprises determining the BChE genotype or phenotype of said mammal.  
     
     
         20 . The method of  claim 17 , wherein said method further comprises obtaining a patient profile of said mammal.  
     
     
         21 . The method of  claim 20 , wherein said patient profile includes a determination of said mammal's sex.  
     
     
         22 . The method of  claim 20 , wherein said patient profile includes the genotype of said mammal.  
     
     
         23 . The method of  claim 20 , wherein said patient profile includes the age of said mammal.  
     
     
         24 . A kit for determining a prognosis, said kit including a means for converting the patient profile into a prognosis.  
     
     
         25 . The kit of  claim 24 , wherein said kit contains a means for performing the steps of said conversion.  
     
     
         26 . The kit of  claim 24 , wherein said kit contains a means for compiling the data for said patient profile.  
     
     
         27 . The kit of  claim 24 , wherein said kit contains a computer software program to perform the data analysis.