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United States Patent (19) 11 Patent Number: 5,192,753 Mcgeer Et Al

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United States Patent (19) 11 Patent Number: 5,192,753 Mcgeer Et Al USOO5192753A United States Patent (19) 11 Patent Number: 5,192,753 McGeer et al. 45 Date of Patent: Mar. 9, 1993 54 ANTI-RHEUMATOID ARTHRITIC DRUGS mentia: Prevalance and Incidence', In: B. Reisberg (ed) N THE TREATMENT OF DEMENTIA Alzheimer's Disease, The Free Press, 1983, 141-148. 76 Inventors: Patrick L. McGeer, 4727 West 2nd R. Sulkava, J. Wikstrom, A. Aromaa et al., "Prevalence Ave., Vancouver, B. C., Canada, of Severe Dementia in Finland’, Neurology 1985; 35: V6T Cl; Joseph Rogers, 7646 W. 1025-1029. Julie Dr., Glendale, Ariz. 85308; S. Itagaki, P. L. McGeer, H. Akiyama, "Presence of John Sibley, 87 Leddy Crescent, T-cytotoxic Suppressor and Leucocyte Common Anti Saskatoon, Saskatchewan, Canada, gen Positive Cells in Alzheimer's Disease Brain Tissue", S7H 3Y9; Edith McGeer, 4727 West Neuroscience Letters 1988; 91: 259-264. 2nd Ave., Vancouver, B.C., Canada, J. Rogers, J. Luber-Narod, S. D. Styren, and W. H. V6T 1C Civin, "Expression of Immune System-Associated An tigens By Cells of the Human Central Nervous System: (21) Appl. No.: 689,499 Relationship to the Pathology of Alzheimer's Disease" (22 Filed: Apr. 23, 1991 Neurobiology of Aging, 1988, vol. 9. 339-349. 51 Int. Cl. ................... A61K 31/60; A61K 31/615; P. L. McGeer, H. Akiyama, S. Itagaki, and E. G. A61K 31/54; A61K 31/44; A61K 3/425; McGeer, "Immune System Response in Alzheimer's A61K 31/42; A61K 31/415, A61K 31/40; Disease', The Canadian Journal of Neurological Sci A61K 31/38; A61K 31/195; A61K 31/19 ences 1989; 16:56-527. 52 U.S. C. .................................... 514/159; 514/162; P. L. McGeer, H. Akiyama, S. Itagaki and E. G. 514/165; 514/226.5; 514/356; 514/365; McGeer, "Activation of the Classical Complement 514/375; 514/404; 514/419,514/420; 514/423; Pathway in Brain Tissue of Alzheimer Patients', Neu 514/428; 514/429; 514/448; 514/567; 514/569; roscience Letters 1989; 107: 341-346. 514/570 P. L. McGeer, E. G. McGeer, J. Rogers and J. Sibley, 58 Field of Search ............... 514/165, 570, 549, 552, "Anti-inflammatory Drugs and Alzheimer Disease", 514/560, 878, 879, 159, 162,226.5, 356, 375, The Lancet 1990; 335: 1037. 404, 419, 420, 423, 428,429, 448, 567, 569 Primary Examiner-Frederick E. Waddell 56) References Cited Assistant Examiner-Raymond J. Henley, III FOREIGN PATENT DOCUMENTS Attorney, Agent, or Firm-Barrigar & Oyen 61-106520 5/1986 Japan. 57) ABSTRACT OTHER PUBLICATIONS This invention pertains to the novel use of anti Martindale, The Extra Pharmacopoeia, 28th Ed. (1982) rheumatoid arthritic drugs in the treatment of dementia. pp. 234-282. A method of treating dementia in human beings which W. N. Kelley, E. D. Harris, Jr., S. Ruddy, and C. B. comprises administering to the human being a therapeu Sledge, "The Textbook of Rheumatology', 1989 W. B. Saunders Company. tic amount of a non-steroidal anti-inflammatory drug D. A. Evans, H. H. Funkenstein, and M. S. Albert et al. (NSAID) which has the ability to inhibit prostaglandin "Prevalence of Alzheimer disease in a community pop synthesis in the human being. ulation of older Persons', JAMA 1989; 262:2551-2556. J. A. Mortiner, "Alzheimer's Disease and Senile De 6 Claims, 2 Drawing Sheets U.S. Patent Mar. 9, 1993 Sheet 1 of 2 5,192,753 O 3 6 MONTHS OF TREATMENT FIG. 2 B. Alzheimer's Assessment Scale O 3. 6 m MONTHS OF TREATMENT FIG.2 U.S. Patent Mar. 9, 1993 Sheet 2 of 2 5,192,753 C. Boston Naming Test 3 O 3 6 MONTHS OF TREATMENT FIG.3 4. D. Token Test U O 83 O 5 -2 93-4 U -6 -8 d -O O 3 6 MONTHS OF TREATMENT FIG.4 5,192,753 1. 2 indoprofen, tiaprofenic acid, benoxaprofen, pir ANTI-RHEUMATOIDARTHRITICDRUGSIN THE profen, tolmetin, zomepirac, clopinac, indometha TREATMENT OF DEMENTIA cin, sulindac; (3) Enolic acids: phenylbutazone, oxyphenbutazone, FIELD OF THE INVENTION azapropazone, feprazone, piroxicam, isoxicam, This invention pertains to the novel use of non-steroi sudoxican. dal anti-inflammatory drugs in the treatment of demen The dosage of each agent will vary. For each patient, it will be the dosage that is required to inhibit effec tia (Alzheimer disease) in human beings. tively prostaglandin synthesis in vivo, but not to induce BACKGROUND OF THE INVENTION O unwanted side effects such as gastrointestinal bleeding. Non-steroidal anti-inflammatory drugs (NSAIDs) are Daily doses of an agent can range from 10 mg to 3g per the drugs of choice for the treatment of rheumatoid 100 kg body weight. arthritis (Textbook of Rheumatology, eds. Kelley, W. The composition can comprise a NSAID cycloox N., Harris, E. D. Jr., Ruddy, S., Sledge, C. B., Saunders ygenase inhibitor and a therapeutically acceptable car Co., 1989). They have fewer side effects than other 15 rier. The substance can be present in the composition at classes of anti-arthritic drugs and are therefore almost a dosage of 5 mg to 1 gm. universally prescribed for this condition. They are char acterized by their ability to inhibit prostaglandin syn DRAWINGS thesis through anti-cyclooxygenase activity. They can In the drawings: be classified chemically as derivatives of arylcarboxylic 20 FIG. 1 illustrates a graphical depiction of Mini-Men acids, including salicylic and anthranilic acid deriva tal Status test results plotted by change of score against tives; arylalkanoic acids, including arylacetic, arylpro months of treatment. pionic, heteroarylacetic, indoleacetic and indeneacetic FIG. 2 illustrates a graphical depiction of Alzhei acids; and enolic acids, including pyrazolidinediones mer's Assessment Scale test results plotted by change of and oxicans. 25 score against months of treatment. While drugs in this class are among the most widely FIG. 3 illustrates a graphical depiction of Boston used in medicine, there is no literature or teaching in the Naming Test test results plotted by change of score art to indicate that any NSAID has been used in the against months of treatment. treatment of Alzheimer's disease (dementia). This brain FIG. 4 illustrates a graphical depiction of Token Test disorder is estimated to affect 0.5-1% of the general 30 population in industrialized countries and threatens to test results plotted by change of score against months of become more prevalent as the average age of the human treatinent. population increases. DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION SUMMARY OF THE INVENTION 35 We have determined that patients with rheumatoid We have conducted research which has demon arthritis, most of whom will have been treated with one strated that changes characteristic of an inflammatory or more of these agents, have a much lower prevalence process occur in Alzheimer brain tissue. The cellular of Alzheimer disease than the age-matched general and protein alterations that we have observed are simi population. We have also determined in a 6 month pilot lar to those seen in other tissues of the body in diseases trial, that Alzheimer cases given indomethacin, a widely where there is an autoimmune disorder, or a persistent, used NSAID, showed little or no mental deterioration. non-lethal pathogen. Rheumatoid arthritis is typical of NSAIDs are relatively safe agents. While they all have such diseases. Such diseases respond to a variety of side effects, such side effects are well known due to anti-inflammatory agents, which have in common the their very extensive use in a wide range of inflammatory 45 ability to inhibit cells which attack the human body's diseases where long term treatment is common. own tissues. Based on this research and not wishing to The invention pertains to a method of treating de be adversely bound by any theories, we have reasoned mentia in human beings which comprises administering that rheumatoid arthritics, who require long term treat to the human being a therapeutic amount of a substance ment with such agents to keep immune system cells selected from the non-steroidal anti-inflammatory 50 from attacking the joint tissue, would be spared from group of cyclooxygenase inhibitors. Alzheimer's disease because such immune system cells The invention also pertains to a composition for treat would be similarly inhibited from attacking their brain ing dementia in human beings which composition com tissue. We have further reasoned that Alzheimer disease prises a substance or substances selected from the group can be effectively treated with any drug of the NSAID consisting of non-steroidal anti-inflammatory cycloox 55 class since drugs of this class are almost universally ygenase inhibitors, therapeutically acceptable salts prescribed at some stage in rheumatoid arthritis. thereof, and therapeutically acceptable carriers. We have conducted a survey of patients suffering Within the terms of the invention, the NSAIDs in from rheumatoid arthritis to determine the prevalence clude, but are not restricted to, the following chemical of Alzheimer disease in such patients. We have found agents that inhibit prostaglandin synthesis primarily by that the prevalence is dramatically lower than the prev their activity against the enzyme cyclooxygenase: alence of dementia in the age-matched general popula (1) Arylcarboxylic acids: salicylic acid, acetylsali tion. The prevalence of Alzheimer disease in the age cylic acid, diflunisal, choline magnesium trisalicy group 65 years and over in North America is reported late, salicylate, benorylate, flufenamic acid, mefe to be from 2.5 to 10.3%, depending on the survey namic acid, meclofenamic acid, niflumic acid; 65 (Evans, D. A., Funkenstein, H. H., Albert, M. S. et al. (2) Arylalkanoic acids: diclofenac, fenclofenac, al Prevalence of Alzheimer Disease in a community popu clofenac, fentiazac, ibuprofen, flurbiprofen, keto lation of older persons. JAMA 1989; 262: 2551-2556; profen, naproxen, fenoprofen, fenbufen, suprofen, Mortiner, J.
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