Method of treating and diagnosing Parkinson's disease and related dysautonomic disorders

• US 9,233,146 B2
• Filed: 09/23/2014
• Issued: 01/12/2016
• Est. Priority Date: 08/14/2000
• Status: Active Grant

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M.
• Primary Examiner(s): Tate, Chris R
• Assistant Examiner(s): White, Douglas F
• Application Number:
  US14/493,734
• Publication Number:
  US 20150023944A1
• Time in Patent Office: 476 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A23V 2200/32 having an effect on the health of the digestive tract
• CPC Class Codes: A23V 2200/322 having an effect on the health of the nervous system or on mental function
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/465 acting on ester bonds (3.1), e.g. lipases, ribonucleases
• CPC Class Codes: A61K 38/47 acting on glycosyl compounds (3.2), e.g. cellulases, lactases
• CPC Class Codes: A61K 38/4826 Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1)
• CPC Class Codes: A61K 38/4873 Cysteine endopeptidases (3.4.22), e.g. stem bromelain, papain, ficin, cathepsin H
• CPC Class Codes: A61K 38/54 Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
• CPC Class Codes: A61P 1/14 Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: C12N 9/94 Pancreatin
• CPC Class Codes: C12Y 301/01003 Triacylglycerol lipase (3.1.1.3)
• CPC Class Codes: C12Y 302/01 Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
• CPC Class Codes: C12Y 304/00 Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
• CPC Class Codes: C12Y 304/21001 Chymotrypsin (3.4.21.1)
• CPC Class Codes: C12Y 304/21004 Trypsin (3.4.21.4)
• CPC Class Codes: C12Y 304/22002 Papain (3.4.22.2)
• CPC Class Codes: G01N 30/00 Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation G01N3/00, G01N5/00, G01N7/00, G01N9/00, G01N11/00, G01N13/00, G01N15/00, G01N17/00, G01N19/00, G01N21/00, G01N22/00, G01N23/00, G01N24/00, G01N25/00, G01N27/00, G01N29/00 take precedence
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72

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

1. A method of assaying and treating an individual having a Dysautonomic Disorder comprising the steps of:

measuring a level of fecal chymotrypsin in a stool sample of the individual;

comparing the level of fecal chymotrypsin with a normal fecal chymotrypsin level; and

administering a pharmaceutical composition comprising a therapeutically effective amount of digestive enzymes to the individual if the level of fecal chymotrypsin in the individual is less than the normal fecal chymotrypsin level, wherein the digestive enzymes comprise a protease, an amylase and a lipase.

2. The method of claim 1, wherein the level of fecal chymotrypsin in the stool sample is measured using a technique selected from the group consisting of enzymatic photospectrometry, colorimetry, treatment with substrates, assays, and a combination thereof.

3. The method of claim 1, wherein the normal fecal chymotrypsin level is approximately 8.4 U/gram.

4. The method of claim 1, wherein the protease comprises chymotrypsin and trypsin.

5. The method of claim 1, wherein the amount of amylase in the pharmaceutical composition comprises from about 10,000 to about 70,000 USP units/dose.

6. The method of claim 1, wherein the amount of protease in the pharmaceutical composition comprises from about 10,000 to about 80,000 USP units/dose.

7. The method of claim 1, wherein the amount of lipase in the pharmaceutical composition comprises from about 4,000 to about 80,000 USP units/dose.

8. The method of claim 1, wherein the digestive enzymes comprise pancreatin.

9. The method of claim 8, wherein the amount of pancreatin in the pharmaceutical composition comprises from about 2,000 to about 6,000 USP units/dose.

10. The method of claim 4, wherein the amount of chymotrypsin in the pharmaceutical composition comprises from about 2 to about 7 mg/dose.

11. The method of claim 4, wherein the amount of trypsin in the pharmaceutical composition comprises from about 60 to about 100 mg/dose.

12. The method of claim 1, wherein the method treats a symptom of the Dysautonomic Disorder selected from the group consisting of constipation, tremors, falls, difficulty in ambulation and a combination thereof.

13. The method of claim 1, wherein the Dysautonomic Disorder is Parkinson'"'"'s Disease.