Uridine therapy for patients with elevated purine levels

Details Uridine therapy for patients with elevated purine levels Uridine therapy for patients with elevated purine levels

2000-10-12

2004-04-27

Wilson, James O. (Department: 1623)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Carbohydrate doai

C514S049000, C536S028500, C536S028530

Reexamination Certificate

active

06727231

ABSTRACT:

TECHNICAL FIELD
This invention relates to the diagnosis and treatment of disorders associated with elevated purine levels, such as pervasive developmental disorders.
BACKGROUND
A variety of grave disorders of human development are associated with elevated purine levels. Patients with these disorders may have seizures, transient ischemic attacks, and neurological and neuromuscular impairments such as ataxia and spasticity. In addition, such patients may exhibit profound developmental, behavioral, and psychological problems. For example, they may exhibit symptoms of Pervasive Developmental Disorder (PDD). PDD is a diagnostic category first used in the 1980s to describe a group of patients who typically exhibit one or more severe impairments including: reduced or absent social interaction, cognitive delay, attentional deficits, impaired learning, distorted sensory perception, deficient imaginative activity, and deficiency or absence of verbal and nonverbal communication skills. In addition, all have a limited number of interests and demonstrate activities that tend to be repetitive. The various types of PDD are typically diagnosed following the guidelines in the Diagnostic and Statistical Manual of Mental Disorders (DSM)(American Psychiatric Association, Washington, D.C., pages 66-71, 1994). The fourth edition of these guidelines, DSM-IV, identifies five separate disorders under the category of Pervasive Developmental Disorders: (1) Autistic Disorder, (2) Rett's Disorder, (3) Childhood Disintegrative Disorder, (4) Asperger's Disorder, and (5) Pervasive Developmental Disorder Not Otherwise Specified, or PDDNOS.
Autistic disorder or autism is a severely debilitating developmental disorder characterized by deficiency in verbal communication and socialization. In addition, children with autistic disorder typically have moderate to severe behavioral problems. Many children with autism also have mental retardation. Autism is generally diagnosed in children between the ages of 2 and 6, typically using the criteria established in DSM-IV ((APA, 1994, p. 70-71).
A child is diagnosed as having autistic disorder if the child fits into all of categories A, B, and C as follows.
A. A total of six (or more) items from (1), (2), and (3), with at least two from (1), and one each from (2) and (3):
(1) qualitative impairment in social interaction, as manifested by at least two of the following: (a) marked impairment in the use of multiple nonverbal behaviors such as eye-to-eye gaze, facial expression, body postures, and gestures to regulate social interaction; (b) failure to develop peer relationships appropriate to developmental level; (c) a lack of spontaneous seeking to share enjoyment, interests, or achievements with other people (e.g., by a lack of showing, bringing, or pointing out objects of interest); and (d) lack of social or emotional reciprocity.
(2) qualitative impairments in communication as manifested by at least one of the following: (a) delay in, or total lack of, the development of spoken language (not accompanied by an attempt to compensate through alternative modes of communication such as gesture or mime); (b) in individuals with adequate speech, marked impairment in the ability to initiate or sustain a conversation with others; (c) stereotyped and repetitive use of language or idiosyncratic language; and (d) lack of varied, spontaneous make-believe play or social imitative play appropriate to developmental level.
(3) restricted repetitive and stereotyped patterns of behavior, interests, and activities, as manifested by at least one of the following: (a) encompassing preoccupation with one or more stereotyped and restricted patterns of interest that is abnormal either in intensity or focus; (b) apparently inflexible adherence to specific, nonfunctional routines or rituals; (c) stereotyped and repetitive motor mannerisms (e.g., hand or finger flapping or twisting, or complex whole-body movements); and (d) persistent preoccupation with parts of objects.
B. Delays or abnormal functioning in at least one of the following areas, with onset prior to age 3 years:
(1) social interaction,
(2) language as used in social communication, or
(3) symbolic or imaginative play.
C. The disturbance is not better accounted for by Rett's Disorder or Childhood Disintegrative Disorder.
Asperger's Disorder, also referred to as Asperger's or Asperger's Syndrome, is a developmental disorder characterized by a lack of social skills; difficulty with social relationships; poor coordination and concentration; and a restricted range of interests, but normal intelligence and adequate language skills. Individuals with Asperger's Disorder do not possess a significant delay in language development, but they may have difficulty understanding certain aspects of conversation such as irony and humor. Asperger's patients tend to have an average or above average intelligence. A child is diagnosed with Asperger's Disorder if they meet the diagnostic criteria set forth in the DSM-IV in categories A through F as follows (APA, 1994, p. 77).
A. Qualitative impairment in social interaction, as manifested by at least two of the following:
(1) marked impairment in the use of multiple nonverbal behaviors such as eye-to-eye gaze, facial expression, body postures, and gestures to regulate social interaction;
(2) failure to develop peer relationships appropriate to developmental level;
(3) a lack of spontaneous seeking to share enjoyment, interests, or achievements with other people (e.g., by a lack of showing, bringing, or pointing out objects of interest); and
(4) lack of social or emotional reciprocity.
B. Restricted repetitive and stereotyped patterns of behavior, interests, and activities, as manifested by at least one of the following:
(1) encompassing preoccupation with one or more stereotyped and restricted patterns of interest that is abnormal either in intensity or focus;
(2) apparently inflexible adherence to specific, nonfunctional routines or rituals;
(3) stereotyped and repetitive motor mannerisms (e.g., hand or finger flapping or twisting, or complex whole-body movements); and
(4) persistent preoccupation with parts of objects.
C. The disturbance causes clinically significant impairment in social, occupational, or other important areas of functioning.
D. There is no clinically significant general delay in language (e.g., single words used by age 2 years, communicative phrases used by age 3 years).
E. There is no clinically significant delay in cognitive development or in the development of age-appropriate self-help skills, adaptive behavior (other than in social interaction), and curiosity about the environment in childhood.
F. Criteria are not met for another specific Pervasive Developmental Disorder, or Schizophrenia.
When an individual has several of the symptoms of the other specific PDDs, but does not quite meet all of the criteria or is not severely impaired, Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS) may be diagnosed. Children with PDDNOS either (a) do not fully meet the criteria of symptoms clinicians use to diagnose any of the four specific types of PDD above, and/or (b) do not have the degree of impairment described in any of the above four PDD specific types.
Besides their developmental and behavioral problems, a significant subgroup of children diagnosed with autistic disorder, other PDDs, and/or neuromuscular symptoms, have also been shown to have an abnormal purine metabolism, as evidenced, for example, by hyperuricosuria, a condition in which the patient, e.g., a child, excretes an abnormally high level of uric acid in his or her urine than normal children and other autistic children. See, Page and Coleman,
Biochimica et Biophysica Acta,
61913:1-6 (2000). Some of these patients also exhibit a marked abnormality of about a two to four-fold increase in de novo purine synthesis. A low purine diet, which lowers urate excretion, has been shown to improve the symptoms in some of these patients. In addition, some of these patients have ben

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