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(12) United States Patent (10) Patent No.: US 7,619,005 B2 Epstein Et Al

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(12) United States Patent (10) Patent No.: US 7,619,005 B2 Epstein Et Al US007619005B2 (12) United States Patent (10) Patent No.: US 7,619,005 B2 Epstein et al. (45) Date of Patent: *Nov. 17, 2009 (54) METHODS FORTREATING COGNITIVE 5,220,068 A 6/1993 Knoll et al. IMPAIRMENT INHUMANS WITH MULTIPLE 5,225,446 A 7/1993 Milgram SCLEROSIS 5,422,355 A 6/1995 White et al. 5,684,018 A 11/1997 Alexander 5,914, 129 A 6/1999 Mauskop (75) Inventors: Mel H. Epstein, Bristol, RI (US); 6,104,956 A 8, 2000 Naritoku et al. Kjesten A. Wiig, Providence, RI (US); 6,204.245 B1 3/2001 Siegel et al. Randall L. Carpenter, Waban, MA 6,228,875 B1 5, 2001 Tsai et al. (US) 6,251,938 B1 6/2001 Chorev et al. 6,284,760 B1 9, 2001 Marston et al. (73) Assignee: Cognition Pharmaceuticals LLC, New 6,451,806 B2 9, 2002 Farrar York, NY (US) 6,492.427 B2 12/2002 Shankar et al. 6,635,675 B2 10/2003 Kranzler et al. (*) Notice: Subject to any disclaimer, the term of this 6,699.495 B2 3/2004 Blume et al. patent is extended or adjusted under 35 6,828,351 B2 12/2004 Epstein et al. U.S.C. 154(b) by 157 days. 7,244,769 B2* 7/2007 Epstein et al. .............. 514,654 2002/0066457 A1 6/2002 Landfield et al. 2002fO115725 A1 8/2002 Epstein et al. This patent is Subject to a terminal dis 2007/0099999 A1* 5/2007 Epstein et al. .............. 514,649 claimer. 2007/0100000 A1* 5/2007 Epstein et al. .... ... 514,649 (21) Appl. No.: 11/133,144 2007/01 17869 A1* 5/2007 Epstein et al. .............. 514,649 FOREIGN PATENT DOCUMENTS (22) Filed: May 19, 2005 EP 1743 641 A2 1 1707 (65) Prior Publication Data GB 2 122 617 1, 1984 WO WO97/17067 A1 5, 1997 US 2006/01 11448A1 May 25, 2006 WO WO 97.26871 A1 7/1997 WO WO99,16746 A1 4f1999 Related U.S. Application Data WO WOOO/O1379 A1 1, 2000 WO WOOO,32556 A1 6, 2000 (63) Continuation-in-part of application No. PCT/US2004/ WO WOOO,594.79 A1 10, 2000 015974, filed on May 21, 2004, which is a continua WO WOO1/O9897 A1 2, 2001 tion-in-part of application No. 10/791,223, filed on WO WOO2,39998 A2 5, 2002 Mar. 2, 2004, which is a continuation-in-part of appli WO WO O2/O53104 A2 T 2002 cation No. 10/444,970, filed on May 23, 2003, now abandoned, which is a continuation-in-part of applica OTHER PUBLICATIONS tion No. 10/139,606, filed on May 2, 2002, now aban doned, which is a continuation-in-part of application Chertkow, H., “Mild Cognitive Impairment.” Curr. Opin. in Neurol. 15:401–407 (2002). No. 10/003,740, filed on Oct. 31, 2001, now Pat. No. Clarke, A., “A New Formulation of Selegiline: Improved Bioavail 6,828,351. ability and Selectivity for MAO-B Inhibition.” J. Neural. Transm. (60) Provisional application No. 60/245,323, filed on Nov. 110: 1241-1255 (2003). 1, 2000, provisional application No. 60/473,168, filed Gauthier, S., et al., “Mild Cognitive Impairment.” The Lancet on May 23, 2003. 367: 1262-1270 (2006). Grundman, M., et al., “Mild Cognitive Impairment Can Be Distin guished From Alzheimer Disease and Normal Aging for Clinical (51) Int. Cl. Trials.” Arch. Neurol. 61:59-66 (2004). A6 IK3I/35 (2006.01) Halgren, E., et al., “Human Hippocampal Formation EEG A6 IK 3/445 (2006.01) Desynchronizes During Attentiveness and Movement.” (52) U.S. Cl. ....................................... 514/654; 514/317 Electroencephalography and Clinical Neurophysiology 44:778-781 (58) Field of Classification Search ....................... None (1978). See application file for complete search history. (Continued) (56) References Cited Primary Examiner Brian-Yong S Kwon U.S. PATENT DOCUMENTS (74) Attorney, Agent, or Firm—Hamilton, Brook, Smith & 2,828,343 A 3, 1958 Tindall Reynolds, P.C. 3,728.445 A 4, 1973 Bardani 3.996,381 A 12/1976 Florvallet al. (57) ABSTRACT 4,034,113 A 7/1977 Shulgin 4,105,695 A 8/1978 Partyka et al. Cognitive impairments in humans with multiple Sclerosis are 4,479,932 A 10, 1984 Bodor treated and cognition is improved with an amphetamine com 4,598,094. A 7, 1986 Wurtman et al. pound. In one embodiment, the method includes administer 4,636,494. A 1, 1987 Growdon et al. ing an 1-amphetamine compound. In another embodiment, 4,647,591 A 3, 1987 Cherkin et al. 5,019,594 A 5, 1991 Wurtman et al. the method includes administering an 1-methamphetamine 5,075,338 A 12/1991 Knoll et al. compound. 5,096,712 A 3, 1992 Wurtman 5,151,449 A 9/1992 Milgram 8 Claims, 55 Drawing Sheets US 7,619,005 B2 Page 2 OTHER PUBLICATIONS BartZokis, G., et al., “Selegiline Effects on Cocaine-Induced Changes in Medial Temporal Lobe Metabolism and Subjective Ratings of Kwon, Y. S., et al., “Selegiline Potentiates the Effects of Egb 761 in Euphoria.” Neuropsychopharmacology, 2006): 582-590 (1999). Response to Ischemic Brain Injury.” Neurochemistry International Bauer, R. and Evey, L., “Differential Effects of L-Amphetamine on 45:157-170 (2004). Ontogeny of Active Avoidance, Intertitial Responses, and Locomotor Lynch, G., et al., “The Nature and Causes of Hippocampal Long-term Activity.” Psychopyharmacology 75: 299-304 (1981). Potentiation.” Progress in Brain Research 83:233-250 (1990). Beckett, A.M., et al., “Metabolic Oxidation on Aliphatic Basic Nitro Meeker, J.S. and Reynolds, P.C., “Postmortem Tissue gen Atoms and Their O-carbon Atoms-Some Unifying Principles.” Methamphetamine Concentrations Following Selegiline Administra Letters to the Editor; J. Pharm. Pharmac. 23:809-812 (1971). tion.” J. of Analytical Toxicology 14:330-331 (1990). Berlyne, D. E., "Arousal, Reward and Learning.” Ann. N. Y. Acad. Mild Cognitive Impairment. Alzheimer's Society Information Sheet Sci., 159(3): 1059-1070 (1969). online). Mar. 2005. Retrieved from the Internet <URL: http://www. Biel, J. H. "Structure-Activity Relationships of Amphetamine and alzheimers.org.uki>. Derivatives.” Amphetamines and Related Compounds, 3-19 (1970). Mild Cognitive Impairment-Alzheimer's Disease Part XVI, online Biel, J. H. and Bopp. B. A., “Amphetamines: Structure-Activity Nov. 2006 retrieved on Jan. 24, 2007. 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