Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Patent
1996-05-06
1999-12-28
Duffy, Patricia A.
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
435 721, 435 792, 436503, 436518, 436811, G01N 3353
Patent
active
060080019
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention is generally in the field of diagnostic assays. More specifically, the present invention provides an assay for the diagnosis of mental disorders, particularly schizophrenia.
PRIOR ART
The following is a list of prior publications referred to in the present specification: disease process? Br. Med. J., 280:66-68. and Drug Treatment of Psychiatric Disorders: Adults and Children. Williams and Wilkins, Baltimore. re-examination of the positive-negative dichotomy, Br. J. Psychiatr., 151:145-151. immunological disorder? Psychiatr. Clin. North. Am., 9:115-132. against brain in sera from schizophrenic patients? Review and Perspectus. Biol. Psychiatry, 20:94-119. schizophrenia an autoimmunologic receptor disorder? Med. Hypothes. 12:85-93. Neuromodulating activity of antibrain antibodies. Int. Rev. Neurobiol., 26:249-314. Elizur., A, 1991. Platelet autoantibodies in dementia and schizophrenia--possible implication for mental disorders, An. N.Y Acad. Sc. 621:205-217. Detection and quantification of platelet-bound antibodies with immunoperoxidase, Br. J. Haematol, 42:605-611.
The acknowledgement herein of the above art, should not be construed as an indication that this art is in any way relevant to the patentability of the invention as defined in the appended claims.
The above publications will be acknowledged in the following by indicating their number from the above list:
BACKGROUND OF THE INVENTION
It is becoming clear today that mental disorders are a scientific reflection of the biological abnormalities in the brain. However, notwithstanding the growing understanding of brain anatomy and function, which allows at time a post-mortem diagnosis of a mental disorder, for most mental disorders there are no available objective assays which will allow their diagnosis in living individuals. Psychiatrists or neurologists when attempting to diagnose a mental disorder, have to rely on a series of tests, which very often cannot be interpreted unequivocally. Such a test series is generally a tedious process and there are thus no effective means available today to a practitioner, for a large scale screening of mental disorders.
Schizophrenia is one of the most severe and prevalent mental disorders. Due to its varied symptomatology and to its complex etiology, it is still debatable whether schizophrenia represents a distinct mental disorder, or several different mental diseases grouped under a common name.
A correlation between the occurrence of schizophrenia and the occurrence of various physiological phenomena has been found, but the relevancy of these phenomena to the disease's etiology is still debatable.sup.1-3. Despite lack of consistent experimental evidence, hypotheses concerning the involvement of autoimmune elements in schizophrenia have been suggested.sup.4-7. However, positive indication to the presence of autoantibodies in schizophrenic patients were obtained only in about 25% of tested patients.sup.4,5.
The existence of elevated levels of autoantibodies on blood platelets of both schizophrenic and demented patients has been reported recently.sup.8. In that study, the level of autoantibodies present on the surfaces of blood platelets (termed hereinafter "platelet associated antibodies" (PAA)) isolated from schizophrenic patients, patients with other effective mental disorders, dementia patients, (both treated with neuroleptics and untreated) and normal control subjects was determined by the use of anti-human IgA, IgE, IgG and IgM antibodies. The results of this study demonstrated that schizophrenic patients and demented patients had on the average about twice the level of PAA as compared to age-matched normal controls. Notwithstanding this statistically significant difference in the level of PAA between schizophrenic and demented patients versus normal controls, the difference was too small to serve as a basis for diagnosis of schizophrenia or dementia, or for screening populations for these mental disorders owing to the high proportion of both false positive and
REFERENCES:
patent: 4717654 (1988-01-01), Savoca
T. J. Crow, "Molecular Pathology of Schizophrenia: More Than One Disease Process?", British Medical Journal,vol. 280, pp. 66-68, Jan. 12, 1980.
Peter F. Liddle, "The Symptoms of Chronic Schizophrenia. A Re-examination of the Positive-Negative Dichotomy", British Journal of Psychiatry, vol. 151, pp. 145-151, 1987.
Lynn E. Delisi, M.D. et al., "Is Schizophrenia a Viral or Immunologic Disorder?", Psychiatric Clinics of North America, vol. 9, No. 1, pp. 115-132, Mar. 1986.
Lynn E. Delisi et al., "Are There Antibodies Against Brain in Sera from Schizophrenic Patients? Review and Prospectus", Biol. Psychiatry, vol. 20, 110-115, 1985.
H. H. Fudenberg et al., "Is Schizophrenia an Immunologic Receptor Disorder?", Medical Hypotheses, vol. 12, pp. 85-93, 1983.
Branislav D. Jankovic, "From Immunoneurology to Immunopsychiatry: Neuromodulating Activity of Anti-Brain Antibodies", International Review of Neurobiology, vol. 26, pp. 249-314, 1985.
Meir Shinitzky et al., "Platelet Autoantibodies in Dementia and Schizophrenia Possible Implication for Mental Disorders", Annals New York Academy of Sciences, vol. 621, pp. 205-217.
Michel Leporrier et al., "Detection and Quantification of Platelet-bound Antibodies with Immunoperoxidase", British Journal of Haematology, vol. 42, pp. 605-611, 1979.
Brian R. Clark et al., "Enzyme-Linked immunosorbent Assay (ELISA): Theoretical and Practical Aspects", Enzyme-Immunoassay, published 1980 by CRC Press, Inc. (Boca Raton, FL), pp. 167-179.
Alister Voller et al., "Enzyme-Linked Immunosorbent Assay", Manual of Clinical Laboratory Immunology, published 1989 by American Society for Microbiology (Washington, D.C.), pp. 99-109.
Tanning, Tissue Antigens, 25:19-27, 1985.
Leporrer et al, British Journal of Haematology, 42:605-611, 1979.
Shinitzky et al, Annals New York Academy of Scunces, 621:205-217, 1991.
Harlow et al, Antobodies: A Laboratory Manual, Cold Spring Harbor Press, NY 1988, pp. 205-217, 234-237 and 560-566 and 626-631.
Duffy Patricia A.
Yeda Research and Development Co. Ltd.
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