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WO 2016/135707 Al 1 September 2016 (01.09.2016) P O P C T

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WO 2016/135707 Al 1 September 2016 (01.09.2016) P O P C T (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2016/135707 Al 1 September 2016 (01.09.2016) P O P C T (51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, G01N 33/564 (2006.01) G01N 33/82 (2006.01) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (21) International Application Number: HN, HR, HU, ID, IL, EST, IR, IS, JP, KE, KG, KN, KP, KR, PCT/IB20 16/05 1093 KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (22) International Filing Date: MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, 26 February 2016 (26.02.2016) PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, (25) Filing Language: English TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (26) Publication Language: English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 62/126,347 27 February 2015 (27.02.2015) U S GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, (71) Applicant: NESTEC S.A. [CH/CH]; Avenue Nestle 55, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, 1800 Vevey (CH). DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, (72) Inventors: RUIZ, Juan A.; 4099 Highway 190 East Ser¬ SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, vice Rd., Covington, Louisiana 70433 (US). KOCH, JR., GW, KM, ML, MR, NE, SN, TD, TG). Harold O.; 4099 Highway 190 East Service Rd., Coving¬ ton, Louisiana 70433 (US). BARRENTINE, Lori W.; Published: 4099 Highway 190 East Service Rd., Covington, Louisiana — with international search report (Art. 21(3)) 70433 (US). DURGA, Jane; 4099 Highway 190 East Ser¬ vice Rd., Covington, Louisiana 70433 (US). — before the expiration of the time limit for amending the claims and to be republished in the event of receipt of (81) Designated States (unless otherwise indicated, for every amendments (Rule 48.2(h)) kind of national protection available): AE, AG, AL, AM, (54) Title: DIAGNOSIS OF MAJOR DEPRESSIVE DISORDER, MILD COGNITIVE IMPAIRMENT, AND ALZHEIMER'S DISEASE AND OTHER NEUROLOGIC AND PSYCHIATRIC DISORDERS (57) Abstract: The present invention provides methods for diagnosing a subject with depression, Unmatched Treatment Units e.g., major depressive disorder (MDD), mild cog¬ nitive impairment (MCI) or Alzheimer's dis¬ ease-related diseases (ADRD). The present inven¬ tion also provides methods for recommending or selecting a treatment therapy, such as a combina¬ Matched Treatment Units tion therapy or adjunctive therapy comprising a folate formulation and an antidepressant for MDD or comprising a folate formulation and an acet¬ ylcholinesterase inhibitor and/or memantine for Matched Control Units MCI or ADRD, for the subject. Unmatched Control Units o 0.2 0.4 0.6 1.0 Propensity Score FIG. 1 o DIAGNOSIS OF MAJOR DEPRESSIVE DISORDER, MILD COGNITIVE IMPAIRMENT, AND ALZHEIMER'S DISEASE AND OTHER NEUROLOGIC AND PSYCHIATRIC DISORDERS CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Application No. 62/126,347, filed February 27, 2015, the disclosure is hereby incorporated by reference in its entirety for all purposes. BACKGROUND OF THE INVENTION [0002] Major Depressive Disorder (MDD) is a neuropsychiatric condition that afflicts anywhere from 10 to 20% of the population. The most common age of onset is between 30 and 40 years, with a later peak between 50 and 60 years of age. In the United States, MDD is a contributing cause to the majority of the approximately 30,000 annual deaths by suicide. Diagnosis and severity of MDD are based on a clinician assessment of a defined set of specific signs and symptoms experienced by the subject during one or more major depressive episodes (See, e.g., American Psychiatric Association (2013), Diagnostic and statistical manual of mental disorders: DSM-5, Washington, D.C. American Psychiatric Association). This subjective diagnostic method relies on the subject's self-reported experiences and observed behavior. In addition, many MDD patients do not adequately respond to antidepressant treatment, with 70% of patients failing to achieve remission on their initial antidepressant and 2 out of 3 patients requiring more than one antidepressant (see, Trivedi MH, et al. AM J Psychiatry, 2006; 163(1): 28-40. Warden D, et al. Curr Psychiatry Rep. 2007; 9(6): 449-59). Since major depressive disorder is a heterogeneous illness, there is a need in the art for more effective methods of objectively diagnosing and/or assessing the severity and prognosis of MDD. [0003] Individuals diagnosed with mild cognitive impairment (MCI) have cognitive impairments beyond that expected for their age and education, but that typically do not interfere significantly with their daily activities (see, e.g., Petersen et al., Arch Neuro, 56(3):303-308, 1999; Gauthier et al., Lancet, 367: 1262-1270, 2006; Petersen et al., Arch Neurol, 66: 1447-1455, 2009). MCI is considered to be a clinical stage distinct from normal aging and dementia. Diagnosis of MCI can involve a comprehensive clinical assessment including clinical observation, neuroimaging, blood tests and neuropsychological testing, similar to that used for diagnosing Alzheimer's disease. MCI can be diagnosed if there is evidence of: a cognitive or memory complaint by the individual and/or a family member; cognitive or memory impairment for age; a change in functional abilities; generally preserved activities of daily life, possibly with increased difficulty; and an absence of dementia. Current methods for diagnosing the disorder are based on cognitive or memory assessments performed by a clinician. For example, subjects scoring higher than 24 of a Folstein Mini- Mental State Examination (MMSE) can be diagnosed with MCI. [0004] Alzheimer's disease and related disorders (ADRD) are debilitating conditions that impair memory, thought processes, and functioning, primarily among older adults. The effects of these diseases can be devastating, both for individuals afflicted with ADRD and for their families. People with ADRD require significant amounts of health care and intensive long-term services and support such as management of chronic conditions, medications, supervision and care, or assistance with personal care activities, such as eating, bathing, and dressing. In the United States, ADRD affects as many as 5 million people and nearly 40% of the population aged 85 and older. Roughly 13.2 million older Americans are projected to have ADRD by 2050. [0005] Alzheimer's disease (AD) is an age-related, non-reversible brain disorder that develops over a period of years. The symptoms of AD gradually lead to behavior and personality changes, a decline in cognitive abilities such as decision-making and language skills, and problems recognizing family and friends. AD ultimately leads to a severe loss of mental function. These losses are related to the worsening breakdown of the connections between certain neurons in the brain and their eventual death. AD is one of a group of disorders called dementias that are characterized by cognitive and behavioral problems. It is the most common cause of dementia among people age 65 and older. [0006] Cerebral folate deficiency (CFD) is defined as any neurological syndrome associated with low cerebrospinal fluid (CSF) 5-methyltetrahydrofolate (5MTHF) levels, the active folate metabolite, in the presence of normal folate metabolism outside the nervous system. CFD can result from either disturbed folate transport or from increased folate turnover within the central nervous system (CNS). [0007] There remains a need in the art for molecular marker-based methods for diagnosing the risk or aiding in the diagnosing of the risk for major depressive disorder (MDD), mild cognitive impairment (MCI), AD-related disorders and CFD in an individual. The present invention fulfills this and other needs as well. BRIEF SUMMARY OF THE INVENTION [0008] In one embodiment, the present invention provides a method for aiding in the diagnosis of a risk for major depressive disorder (MDD) and/or the risk of inadequate response to antidepressant treatments in a subject. The method comprises detecting or quantitating the level or amount of autoantibodies to folate receptor alpha (FRa) in a sample from the subject; and diagnosing the subject as having a risk for MDD by the presence of autoantibodies to folate receptor alpha (FRa). In some aspects, detecting or quantitating comprises performing an immunoassay with a folate receptor as an antigen. In other aspects, detecting or quantitating comprises using a homogeneous mobility shift assay (HMSA). [0009] In yet another embodiment, the present invention provides a method for treating a subject having MDD. The method comprises detecting or quantitating the level of autoantibodies to folate receptor alpha (FRa) in a sample from the subject; and administering a treatment comprising a therapeutically effective amount of a folate containing formulation and a therapeutically effective amount of an antidepressant drug to the subject to ameliorate at least one symptom of MDD if the presence of autoantibodies to FRa is detected or determined. [0010] In some aspects, the sample is selected from the group of whole blood, serum, plasma, urine, saliva and cerebral spinal fluid (CSF). In some embodiments, the sample is a serum sample. In other embodiments, the sample is a cerebral spinal fluid (CSF) sample. [0011] In some aspects, the subject has lower than normal levels of MTHF in CSF.
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