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

• US 20020086290A1
• Filed: 04/13/2000
• Published: 07/04/2002
• Est. Priority Date: 12/16/1997
• Status: Abandoned Application

• Current Assignee: McGill University
• Original Assignee: McGill University
• Inventors: Wiebusch, Heiko, Sevigny, Pierre, Schappert, Keith
• Application Number:
  US09/548,540
• Publication Number:
  US 20020086290A1
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: A61K 49/0004 Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Q 2600/156 Polymorphic or mutational markers
• CPC Class Codes: G01N 33/6896 Neurological disorders, e.g. Alzheimer's disease
• CPC Class Codes: Y10S 435/81 Packaged device or kit

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.

Claims

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.

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.

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.

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.

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.

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.

24. A kit for determining a prognosis, said kit including a means for converting the patient profile into a prognosis.