Methods and compositions for the treatment of symptoms of prion diseases
A therapeutic composition for the treatment of the symptoms of prion diseases and the method for preparing the therapeutic agents is disclosed. The therapeutic composition is a stable pharmaceutical composition comprising one or more digestive and/or pancreatic enzymes. The therapeutic composition may be manufactured by a variety of encapsulation technologies. Delivery of the therapeutic composition may be made orally, through injection, by adherence of a medicated patch or other method. Further, a method of using fecal chymotrypsin level as a biomarker for the presence of a prion disease, or the likelihood of an individual to develop a prion disease is disclosed.
1. A method of identifying a subject with an infectious prion disease that can be treated with digestive enzymes, the method comprising:
obtaining a fecal sample from the subject;
measuring a level of fecal chymotrypsin (FCT) present in the fecal sample using an enzymatic photospectrometry method; and
thereby determining that the subject having the prion disease will benefit from administration of a composition that comprises digestive enzymes when the level of fecal chymotrypsin is 8.4 U/gram or less, wherein the prion disease is not Fatal Familial Insomnia.
2. The method of claim 1 , wherein the infectious prion disease comprises Gerstmann-Sträussler-Scheinker Syndrome.
3. The method of claim 1 , wherein the infectious prion disease comprises a Creutzfeldt-Jakob Disease, and the Creutzfeldt-Jakob Disease comprises an iatrogenic Creutzfeldt-Jakob Disease, or a variant Creutzfeldt-Jakob Disease.
4. The method of claim 1 , further comprising administering the subject an of a pharmaceutical composition that comprises digestive enzymes.
5. The method of claim 4 , wherein the pharmaceutical composition is a dosage formulation selected from the group consisting of a pill, a tablet, a capsule, a microcapsule, a mini-capsule, a time-released capsule, a mini-tab, a sprinkle, and a combination thereof.
6. The method of claim 4 , wherein the digestive enzymes comprise a protease, an amylase, and a lipase.
7. The method of claim 4 , wherein the pharmaceutical composition further comprises one or more enzymes selected from the group consisting of a cellulase, a sucrase, a maltase, a papaya , and a papain.
8. The method of claim 4 , wherein the digestive enzymes comprise pancreatic enzymes.
9. The method of claim 4 , wherein the digestive enzymes are, independently, animal enzymes, microbial enzymes, plant enzymes, or synthetically-prepared enzymes.
10. The method of claim 9 , wherein the digestive enzymes comprise animal enzymes derived from a pig.
11. The method of claim 4 , wherein the pharmaceutical composition comprises at least one amylase, a mixture of proteases comprising chymotrypsin and trypsin, at least one lipase, and papain.
12. The method of claim 6 , wherein a ratio of total protease to total lipase in U.S.P. units in the pharmaceutical composition ranges from about 1:1 to about 20:1.
13. The method of claim 12 , wherein the ratio of total protease to total lipase in U.S.P. units in the pharmaceutical composition ranges from about 4:1 to about 10:1.