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

• US 8,778,335 B2
• Filed: 03/11/2008
• Issued: 07/15/2014
• Est. Priority Date: 08/14/2000
• Status: Expired due to Term

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M.
• Primary Examiner(s): BALLARD, KIMBERLY
• Application Number:
  US12/046,252
• Publication Number:
  US 20080152637A1
• Time in Patent Office: 2,317 Days
• US Class Current: 424/94.2
• 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 treating an individual having Parkinson'"'"'s disease with a therapeutically effective amount of a pharmaceutical composition comprising a protease, a lipase, and an amylase, comprising:

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 the pharmaceutical composition comprising a protease, a lipase, and an amylase to the individual if the level of fecal chymotrypsin in the individual is less than the normal fecal chymotrypsin level.

2. The method of claim 1, wherein the pharmaceutical composition is administered to the individual in an amount effective to promote protein digestion in the individual.

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

6. The method of claim 1 or 4, wherein the pharmaceutical composition is an oral dosage form suitable for human use.

7. The method of claim 1 or 4, wherein one or more symptoms of Parkinson'"'"'s disease is ameliorated in the individual.

4. A method of treating an individual having Parkinson'"'"'s disease comprising:

administering a pharmaceutical composition comprising a protease, a lipase, and an amylase to the individual if the level of fecal chymotrypsin in the individual is less than a normal fecal chymotrypsin level, wherein the level of fecal chymotrypsin is measured in a stool sample of the individual.

5. The method of claim 4, wherein the normal fecal chymotrypsin level is approximately 8.4 U/gram.

8. The method of claim 4, wherein the individual having Parkinson'"'"'s disease has one or more symptoms selected from the group consisting of:

constipation, bowel movement frequency, tremors, falls, and difficulty in ambulation, and a combination thereof.