METHODS AND COMPOSITIONS FOR THE TREATMENT OF SYMPTOMS OF NEUROLOGICAL AND MENTAL HEALTH DISORDERS
First Claim
1. A method for treating one or more symptoms associated with a neurological or mental health disorder in a patient diagnosed with the neurological or mental health disorder comprising administering to the patient a therapeutically effective amount of a pharmaceutical composition comprising one or more digestive enzymes.
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Accused Products
Abstract
A therapeutic composition for the treatment of the symptoms of neurological and mental health disorders, such as Alzheimer'"'"'s, bipolar disorder, obsessive compulsive disorder, and oppositional defiant disorder, and the method for preparing the therapeutic agents is disclosed. The therapeutic agent is a stable pharmaceutical preparation containing, but not limited to, digestive/pancreatic enzymes. The therapeutic agent may be manufactured by a variety of encapsulation technologies. Delivery of the therapeutic agent may be made orally, through injection, by adherence of a medicated patch or other method. Further, a method of using fecal chymotrypsin level as an indicator of the presence of neurological and mental health disorders, such as Alzheimer'"'"'s, bipolar disorder, obsessive compulsive disorder, and oppositional defiant disorder, or the likelihood of an individual to develop these disorders is disclosed.
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Citations
60 Claims
- 1. A method for treating one or more symptoms associated with a neurological or mental health disorder in a patient diagnosed with the neurological or mental health disorder comprising administering to the patient a therapeutically effective amount of a pharmaceutical composition comprising one or more digestive enzymes.
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20. A method of diagnosing a patient comprising:
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obtaining a fecal sample from the patient; determining a level of chymotrypsin present in the fecal sample; and diagnosing the patient as having a neurological or mental health disorder if the determined fecal chymotrypsin level is 8.4 U/gram or less and the patient exhibits at least one symptom associated with the neurological or mental health disorder, wherein the neurological or mental health disorder is selected from the group consisting of;
Alzheimer'"'"'s, bipolar disorder, obsessive compulsive disorder, oppositional defiant disorder, and a combination thereof. - View Dependent Claims (21, 22, 23, 24, 25, 26)
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27. A method of identifying a patient likely to benefit from administration of a pharmaceutical composition comprising one or more digestive enzymes comprising:
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obtaining a fecal sample from the patient; determining a level of chymotrypsin present in the fecal sample; and identifying the patient as likely to benefit from administration of the pharmaceutical composition if the determined fecal chymotrypsin level is 8.4 U/gram or less and the patient is diagnosed with a neurological or mental health disorder, wherein the neurological or mental health disorder is selected from the group consisting of;
Alzheimer'"'"'s, bipolar disorder, obsessive compulsive disorder, oppositional defiant disorder, and a combination thereof. - View Dependent Claims (28, 29, 30, 31)
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32. A pharmaceutical composition comprising one or more digestive enzymes, wherein the one or more digestive enzymes comprise at least one lipase and at least one protease, and wherein the ratio of total proteases to total lipases (in USP units) ranges from about 1:
- 1 to about 20;
1. - View Dependent Claims (33)
- 1 to about 20;
- 34. A pharmaceutical composition comprising at least one amylase, a mixture of proteases comprising chymotrypsin and trypsin, at least one lipase, and papain.
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37. A pharmaceutical preparation for treating an individual exhibiting one or more symptoms of a neurological or mental health disorder comprising a therapeutically effective amount of a digestive enzyme, wherein the neurological or mental health disorder is selected from the group consisting of:
- Alzheimer'"'"'s, bipolar disorder, obsessive compulsive disorder, oppositional defiant disorder, and a combination thereof.
- View Dependent Claims (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57)
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58. A method of treating an individual having a neurological or mental health disorder with a therapeutically effective amount of digestive enzymes comprising the steps of:
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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 digestive enzymes to the individual if the level of fecal chymotrypsin in the individual is less than the normal fecal chymotrypsin level wherein the neurological or mental health disorder is selected from the group consisting of;
Alzheimer'"'"'s, bipolar disorder, obsessive compulsive disorder, oppositional defiant disorder, and a combination thereof. - View Dependent Claims (59, 60)
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Specification