Methods and compositions for the treatment of symptoms of prion diseases

Abstract

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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority under 35 U.S.C. §119 to U.S. Provisional Application 61 / 102818, filed Oct. 3, 2008, incorporated by reference in its entirety herein.TECHNICAL FIELD[0002]This disclosure relates to a treatment for the symptoms of prion diseases, and more particularly, to the use of pharmaceutical compositions comprising one or more digestive enzymes, such as one or more pancreatic enzymes, in the treatment of the symptoms of prion diseases. The disclosure also relates to a method of making pharmaceutical compositions comprising one or more digestive enzymes. The disclosure further relates to the use of an individual's fecal chymotrypsin level as a diagnostic marker for determining whether an individual has a prion disease, as well as to predict whether an individual will be beneficially treated with the described pharmaceutical compositions.BACKGROUND OF THE INVENTION[0003]Dysautonomias can result in symptoms in which one ...

AI Technical Summary

Benefits of technology

The present invention is about a method for treating prion diseases and other dysautonomic conditions by administering a pharmaceutical composition containing one or more digestive enzymes to a patient. The pharmaceutical composition may be lipid-encapsulated and can be administered through various delivery methods such as oral, injection, patch, or other suitable technology. The invention also provides a method for using fecal chymotrypsin level as a biomarker for the presence of prion diseases. The technical effects of the invention include improving the digestion of carbohydrates, fats, and proteins, reducing the burden of pancreatic enzymes, and restoring proper functioning of the gastrointestinal tract.

Problems solved by technology

No cure for prion disease currently exists.

Even if warned of an impending noise, the individual cannot suppress the startle response.

Cognitive dysfunction is generally not apparent early on; however, with progression, bradyphrenia, or slowness of thought processing, may become evident.

Cerebellar dysfunction results in severe dysarthria, gait and appendicular ataxia, ocular dysmetria, and lack of coordination in swallowing.

Advancing disease results in progressively greater loss of total sleep time, worsening ataxia, and more profound confusion, leading ultimately to an awake but stuporous state as death approaches.

As with other forms of prion disease, debilitation leading to feeding difficulties and loss of airway protection is the most common immediate cause of death.

In the later stages of the disease, patients have severe mental impairment and lose the ability to move or speak.