IP Library Granted Patent US 8,012,710
Granted Patent B2
US 8,012,710 · App. 12/487,868 · Granted Sep 6, 2011

Methods of treating and diagnosing Parkinsons disease and related dysautonomic disorders

Assignee: Curemark, LLC
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Quick Facts
Patent No.
US 8,012,710
App. No.
12/487,868
Granted
Sep 6, 2011
Kind
B2
Abstract

A method for treating a Parkinson's patient with digestive/pancreatic enzymes involves administering an effective amount of digestive/pancreatic enzymes to an individual having the disorder in order to improve a symptom of the disorder. In addition, a method is provided for determining whether an individual has, or may develop, Parkinson's disease or related dysautonomic disorders and for determining whether an individual will benefit from the administration of pancreatic/digestive enzymes to treat the dysautonomic disorder.

Claims (61)

1. A method of diagnosing a patient comprising:

a. obtaining a fecal sample from the patient;

b. determining a level of chymotrypsin present in the fecal sample; and

c. diagnosing the patient as having a likelihood to develop a dysautonomic disorder if the determined fecal chymotrypsin level is 8.4 U/gram or less, wherein said dysautonomic disorder is selected from the group consisting of Familial dysautonomia (FD), Diabetic autonomic failure, Parkinson's disease or Orthostatic intolerance.

2. The method of claim 1 , wherein the fecal chymotrypsin level is between 8.4 and 4.2 U/gram.

3. The method of claim 1 , wherein the fecal chymotrypsin level is less than 4.2 U/gram.

4. The method of claim 1 , wherein the level of chymotrypsin present in the fecal sample is determined using an enzymatic photospectrometry method.

5. The method of claim 1 , further comprising determining if the patient exhibits one or more symptoms of a dysautonomic disorder.

6. The method of claim 1 , wherein the patient exhibits one or more symptoms of a dysautonomic disorder.

7. The method of claim 1 , wherein the level of chymotrypsin present in the fecal sample is determined at 30° C.

8. A method of screening a patient comprising:

a. determining the level of chymotrypsin present in a fecal sample obtained from the patient; and

b. identifying the patient as having a likelihood to develop a dysautonomic disorder if the determined chymotrypsin level is 8.4 U/gram or less, wherein said dysautonomic disorder is selected from the group consisting of Familial dysautonomia (FD), Diabetic autonomic failure, Parkinson's disease or Orthostatic intolerance.

9. The method of claim 8 , wherein the level of chymotrypsin present in the fecal sample is determined using an enzymatic photospectrometry method.

10. The method of claim 8 , further comprising determining if the patient exhibits one or more symptoms of a dysautonomic disorder.

11. The method of claim 8 , wherein the level of chymotrypsin present in the fecal sample is determined at 30° C.

12. A method of confirming a diagnosis of a patient as having a dysautonomic disorder or a likelihood to develop a dysautonomic disorder, comprising:

a. obtaining a fecal sample from the patient;

b. determining a level of chymotrypsin present in the fecal sample; and

c. confirming the diagnosis of the patient as having a dysautonomic disorder or a likelihood to develop a dysautonomic disorder if the determined fecal chymotrypsin level is 8.4 U/gram or less, wherein said dysautonomic disorder is selected from the group consisting of Familial dysautonomia (FD), Diabetic autonomic failure, Parkinson's disease or Orthostatic intolerance.

13. The method of claim 12 , wherein the level of chymotrypsin present in the fecal sample is determined using an enzymatic photospectrometry method.

14. The method of claim 12 , further comprising determining if the patient exhibits one or more symptoms of a dysautonomic disorder.

15. The method of claim 12 , wherein the level of chymotrypsin present in the fecal sample is determined at 30° C.

16. A method of confirming a diagnosis of a patient as having a dysautonomic disorder or a likelihood to develop a dysautonomic disorder comprising:

a. determining the level of chymotrypsin present in a fecal sample obtained from the patient; and

b. confirming the diagnosis of the patient as having a dysautonomic disorder or a likelihood to develop a dysautonomic disorder if the determined chymotrypsin level is 8.4 U/gram or less, wherein said dysautonomic disorder is selected from the group consisting of Familial dysautonomia (FD), Diabetic autonomic failure, Parkinson's disease or Orthostatic intolerance.

17. The method of claim 16 , wherein the level of chymotrypsin present in the fecal sample is determined using an enzymatic photospectrometry method.

18. The method of claim 16 , further comprising determining if the patient exhibits one or more symptoms of a dysautonomic disorder.

19. The method of claim 16 , wherein the level of chymotrypsin present in the fecal sample is determined at 30° C.

20. A method of determining if an individual has a likelihood propensity to develop a dysautonomic disorder comprising:

a. determining the fecal chymotrypsin levels of the patient over a period of time; and

b. determining that the individual has a likelihood to develop a dysautonomic disorder if the determined fecal chymotrypsin levels exhibit a decreasing trend over time and at least one level is 8.4 U/gram or less, wherein said dysautonomic disorder is selected from the group consisting of Familial dysautonomia (FD), Diabetic autonomic failure, Parkinson's disease or Orthostatic intolerance.

21. The method of claim 20 , wherein the level of chymotrypsin present in the fecal sample is determined using an enzymatic photospectrometry method.

22. The method of claim 20 , further comprising determining if the patient exhibits one or more symptoms of a dysautonomic disorder.

23. The method of claim 20 , wherein the level of chymotrypsin present in the fecal sample is determined at 30° C.

24. A method of diagnosing a patient comprising:

a. determining a level of chymotrypsin present in a fecal sample obtained from the patient; and

b. diagnosing the patient as having a dysautonomic disorder or having a likelihood to develop a dysautonomic disorder if the determined fecal chymotrypsin level is less than a normal fecal chymotrypsin level, wherein said dysautonomic disorder is selected from the group consisting of Familial dysautonomia (FD), Diabetic autonomic failure, Parkinson's disease or Orthostatic intolerance.

25. The method of claim 24 , wherein the level of chymotrypsin present in the fecal sample is determined at 30° C.

26. The method of claim 24 , wherein the normal fecal chymotrypsin level is a level of fecal chymotrypsin associated with at least one other individual of the same approximate age that does not have the disorder.

27. The method of claim 24 , further comprising determining if the patient exhibits one or more symptoms of a dysautonomic disorder.

28. A method of screening a patient comprising:

a. determining a level of chymotrypsin present in a fecal sample obtained from the patient; and

b. identifying the patient as having a likelihood to develop a dysautonomic disorder if the determined fecal chymotrypsin level is less than a threshold fecal chymotrypsin level, wherein said dysautonomic disorder is selected from the group consisting of Familial dvsautonomia (FD), Diabetic autonomic failure, Parkinson's disease or Orthostatic intolerance.

29. The method of claim 28 , wherein the level of chymotrypsin present in the fecal sample is determined at 30° C.

30. The method of claim 28 , further comprising determining if the patient exhibits one or more symptoms of a dysautonomic disorder.

31. A method of confirming a diagnosis of a patient as having a dysautonomic disorder or having a likelihood to develop a dysautonomic disorder, comprising:

a. determining a level of chymotrypsin present in a fecal sample obtained from the patient; and

b. confirming the diagnosis of the patient as having a dysautonomic disorder or having a likelihood to develop a dysautonomic disorder if the determined fecal chymotrypsin level is less than a normal fecal chymotrypsin level, wherein said dysautonomic disorder is selected from the group consisting of Familial dysautonomia (FD), Diabetic autonomic failure, Parkinson's disease or Orthostatic intolerance.

32. The method of claim 31 , wherein the level of chymotrypsin present in the fecal sample is determined at 30° C.

33. The method of claim 31 , wherein the normal fecal chymotrypsin level is a level of fecal chymotrypsin associated with at least one other individual of the same approximate age that does not have the disorder.

34. The method of claim 31 , further comprising determining if the patient exhibits one or more symptoms of a dysautonomic disorder.

35. A method of confirming a diagnosis of a patient as having a dysautonomic disorder or having a likelihood to develop a dysautonomic disorder, comprising:

a. determining a level of chymotrypsin present in a fecal sample obtained from the patient; and

b. confirming the diagnosis of the patient as having a dysautonomic disorder or having a likelihood to develop a dysautonomic disorder if the determined fecal chymotrypsin level is less than a threshold fecal chymotrypsin level, wherein said dysautonomic disorder is selected from the group consisting of Familial dysautonomia (FD), Diabetic autonomic failure, Parkinson's disease or Orthostatic intolerance.

36. The method of claim 35 , wherein the level of chymotrypsin present in the fecal sample is determined at 30° C.

37. The method of claim 35 , further comprising determining if the patient exhibits one or more symptoms of a dysautonomic disorder.

38. The method of claim 1 , 12 , 16 , 20 , 24 , 28 , 31 or 35 herein the dysautonomic disorder is Parkinson's disease.

39. The method of claim 1 , 12 , 16 , 20 , 24 , 28 , 31 or 35 wherein the dysautonomic disorder is Familial dysautonomia (FD).

40. The method of claim 1 , 12 , 16 , 20 , 24 , 28 , 31 or 35 wherein the dysautonomic disorder is Diabetic autonomic failure.

41. The method of claim 1 , 12 , 16 , 20 , 24 , 28 , 31 or 35 wherein the dysautonomic disorder is Orthostatic intolerance.

Assignments (2)
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY DATA ERROR, LEFT OFF COMMA IN COMPANY NAME PREVIOUSLY RECORDED ON REEL 023026 FRAME 0989. ASSIGNOR(S) HEREBY CONFIRMS THE RECEIVING PARTY IS CUREMARK, LLC. Recorded Feb 14, 2017
From: FALLON, JOAN M.
To: CUREMARK, LLC
Reel/Frame 041716/0008 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 30, 2009
From: FALLON, JOAN M.
To: CUREMARK LLC
Reel/Frame 023026/0989 →
Continuity (6)
Continuation 12046252 · Mar 11, 2008
Division 11555697 · Nov 2, 2006
Continuation In Part 10730567 · Dec 8, 2003
Continuation 09929592 · Aug 14, 2001
Provisional Application 60224991 · Aug 14, 2000
Related Publication 20090285790A1 · Nov 19, 2009