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WO 2008/074896 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date PCT (10) International Publication Number 26 June 2008 (26.06.2008) WO 2008/074896 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 36/185 (2006.01) A61P 25/28 (2006.01) kind of national protection available): AE, AG, AL, AM, A61P 25/00 (2006.01) A61P 25/30 (2006.01) AT,AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, A6IP 25/16 (2006.01) CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, (21) International Application Number: IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, PCT/EP2007/064523 LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, (22) International Filing Date: PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SV, SY, 2 1 December 2007 (21.12.2007) TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of regional protection available): ARIPO (BW, GH, (30) Priority Data: GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, 2006/0942 2 1 December 2006 (21.12.2006) IE ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), 0705001.6 15 March 2007 (15.03.2007) GB European (AT,BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, 60/923,084 12 April 2007 (12.04.2007) US FR, GB, GR, HU, IE, IS, IT, LT,LU, LV,MC, MT, NL, PL, PT, RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, (71) Applicant and GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). (72) Inventor: PRENDERGAST, Patrick T. [IE/AU]; Kenil- worth Station, Byrock, New South Wales 2831 (AU). Published: — with international search report (74) Agent: MURGITRO YD & COMPANY; Unit 1, Block 8, — before the expiration of the time limit for amending the Blanchardstown Corporate Park, Cruiserath Road, Dublin claims and to be republished in the event of receipt of 15, Dublin (IE). amendments (54) Title: COMPOSITIONS AND METHODS FOR TREATMENT OF CHRONIC NEUROLOGICAL DISORDERS (57) Abstract: The present invention provides a composition comprising at least one extract of magnolia,or an analogue, derivative, metabolite or pro-drug thereof, and lecithin. The extract of magnolia may be selected from the group consisting of magnolol (5,5'- diallyl-2,2'-dihydroxybiphenyl, 1), honokiol (5,5'-diallyl-2,4'-dihydroxybiphenyl, 2), taspine and asimilobine. The invention further provides a method of treatment of a chronic neurological disorder using the composition of the invention. The chronic neurological disorder for treatment may be selected from, but is not limited to, drug dependence, in particular drug cravings, Alzheimer's disease and Parkinson's disease. COMPOSITIONS AND METHODS FOR TREATMENT OF CHRONIC NEUROLOGICAL DISORDERS Field of the Invention The present invention relates to compositions and methods for the treatment of chronic neurological disorders. In particular, the present invention provides compositions comprising at least one extract derived from the magnolia plant. The invention further extends to the use of pharmaceutical compositions comprising at least one magnolia extract in the treatment of drug dependency. The compositions of the present invention have further utility in methods of treatment of chronic neurological disorders such as neurodegenerative diseases, including Alzheimer's disease and Parkinson's disease. Background to the Invention Drug or substance dependence is a disorder caused by various types of addictive substances. The number of individuals suffering from drug dependence is estimated to exceed 30 million worldwide. Furthermore, drug dependence has a detrimental effect on society as a whole due to the number of social problems caused by drug dependence and related organic mental disorders. Thus, there is a worldwide demand for an effective treatment for drug dependence. There are two types of drug or substance dependency, namely psychological dependence and physical dependence. Psychological dependence is a dependency of the mind referring to a condition wherein an individual possesses a heightened desire and compulsion to take a certain drug. Physical dependence refers to a condition wherein an individual experiences withdrawal symptoms when levels of the drug are depleted in the subject or when the pharmacological effect of the drug weakens or stops. Most addictive drugs can cause dependence after a single use and once the user is addicted, the symptoms can persist long after the use of the drug is terminated. For these reasons, drug dependency is considered to be a chronic neurological disorder. Furthermore, overdose of such drugs may have a deteriorating effect on the living body and may even cause death. Examples of substances generally known to cause drug dependency include cocaine, opium (heroin, morphine, etc), alcohols, amphetamine (or amphetamine-like substances), caffeine, cannabinoids, hallucinogen, inhalants, nicotine, phencyclidine (or phencyclidine-like substances), sedatives, hypnotic agents and anxiolytic agents. Subjects suffering from drug dependency are often found to be dependent on more than one of these substances. Addictive drugs/substances are classified into the following types according to the symptoms of their use: morphine type, alcohol type, barbiturate type, amphetamine type, cocaine type, cannabinoid type, organic solvent type and hallucinogen type. Methamphetamine (also known as Deoxyephedrine, Pervertin, Anadrex, Metamfetamine, Methylamphetamine, meth or crystal meth) is a highly addictive stimulant drug which activates certain systems in the brain. Specifically, methamphetamine acts as a dopaminergic and adrenergic reuptake inhibitor and as a sympathomimetic. It stimulates the mesolimbic reward pathway resulting in euphoria and excitement for a user. Users are thus prone to addiction and craving. Methamphetamine rapidly enters the brain and triggers a cascading release of dopamine and norepinephrine, and to a lesser extent serotonin. Users may become obsessed or perform repetitive tasks such as cleaning, hand-washing, or assembling and disassembling objects. Withdrawal is characterised by hypersomnia, polyphagia and depression-like symptoms, often accompanied by anxiety and drug-craving. From the onset of drug dependence, the role of the Central Nervous System (CNS) reward system in drug dependence has been examined. The reward system has been identified as the site responsible for intracranial self stimulation related behaviours in animals and plays a role in eliciting senses of pleasure, motivation and euphoria. Drug dependence is difficult to treat as many addictive substances stimulate the reward system, thereby eliciting senses of pleasure in users. Furthermore, the influence of such stimulation remains even after the drug is depleted from the body. This system is therefore closely related to cravings and addiction. The regions of the brain that are closely associated with the reward system are the ventral segmental area (VTA), the nucleus accumbes (NAc), the locus ceruleus and the medical forebrain bundle. In particular, the dopaminergic system projecting from the VTA to the NAc plays a central role in the activation of the reward system. Dopamine derived from the VTA acts on the nerves of the NAc. Cocaine increases the NAc dopamine level through inhibition of dopamine transporters of nerve cells in the NAc. Therefore, an increase of dopamine levels in the NAc is implicated in the inductive mechanism of drug dependence, cravings and addiction. Research in the treatment of drug dependence has focused on the use of drugs that target dopamine or other neurotransmitters indirectly related to the dopaminergic nervous system, such as serotonin, GABA, glutamine acid, receptors thereof or intracellular signalling cascades associated with dopamine receptors. However, no investigation of this kind has resulted in the development of any substance which is effective in the treatment of drug dependence, cravings and addiction. Cocaine or amphetamine dependence is currently treated by psychotherapy. However, the results of treatment with psychotherapy are poor and there is no effective medical therapy available. Treatment with dopamine antagonists or agonists may also be used. However, such treatment has little therapeutic effect. Psychotic disorders induced by cocaine or amphetamine are treated by symptomatic treatment with antipsychotic drugs. Opium or nicotine dependence is treated by symptomatic treatment using alternative substances, such as methadone or nicotine patches. Although such therapy may be effective in the treatment of certain symptoms, the dependency and cravings continue. The inventor has now surprisingly found that a composition comprising an extract of magnolia formulated with lecithin is surprisingly effective in reducing or abolishing drug dependence, and in particular cravings for the drug methamphetamine. The inventor has further identified that the foregoing composition also exhibits a surprising effectiveness in the treatment of other chronic neurological diseases, such as Parkinson's disease and Alzheimer's disease. Summary of the Invention According to a first aspect of the present invention there is provided a composition comprising at least one extract of magnolia, or an analogue, derivative, metabolite or pro-drug thereof, and lecithin.
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