WO2015166463A1 - Administration of citicoline to improve cognitive performance, attentional performance, and motor function - Google Patents

Administration of citicoline to improve cognitive performance, attentional performance, and motor function Download PDF

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Publication number
WO2015166463A1
WO2015166463A1 PCT/IB2015/053178 IB2015053178W WO2015166463A1 WO 2015166463 A1 WO2015166463 A1 WO 2015166463A1 IB 2015053178 W IB2015053178 W IB 2015053178W WO 2015166463 A1 WO2015166463 A1 WO 2015166463A1
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WO
WIPO (PCT)
Prior art keywords
visit
day
group
placebo
groups
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2015/053178
Other languages
English (en)
French (fr)
Inventor
Deborah Yurgelun-Todd
Perry Renshaw
Miho Takada
Takeshi Ikeda
Masahiko Morita
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kyowa Hakko Bio Co Ltd
Original Assignee
Kyowa Hakko Bio Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to AU2015254865A priority Critical patent/AU2015254865B2/en
Priority to US15/307,411 priority patent/US11583546B2/en
Priority to EP15786597.3A priority patent/EP3137067B1/en
Priority to JP2016564605A priority patent/JP6584430B2/ja
Priority to ES15786597T priority patent/ES2915909T3/es
Priority to PL15786597T priority patent/PL3137067T3/pl
Application filed by Kyowa Hakko Bio Co Ltd filed Critical Kyowa Hakko Bio Co Ltd
Priority to CA2947252A priority patent/CA2947252C/en
Priority to NZ725643A priority patent/NZ725643B2/en
Publication of WO2015166463A1 publication Critical patent/WO2015166463A1/en
Anticipated expiration legal-status Critical
Priority to US18/069,325 priority patent/US12115181B2/en
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/66—Phosphorus compounds
    • A61K31/661—Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
    • A61K31/6615—Compounds having two or more esterified phosphorus acid groups, e.g. inositol triphosphate, phytic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the effective amount of citicoline or a salt thereof being administered is an amount that is less than 500 mg per day.
  • the studies conducted involve healthy subject groups generally administered with either high dose of citicoline (500 mg/day) or low dose of citicoline (250 mg/day).
  • Participants also provided a urine sample for drug screening and a blood sample for comprehensive chemistry panel (sodium, potassium, chloride, BUN, creatinine, glucose, calcium, magnesium, phosphorus), liver function tests (SGOT, SGPT, GGT, total bilirubin, albumin), a full blood count (WBC, RBC, platelet count).
  • comprehensive chemistry panel sodium, potassium, chloride, BUN, creatinine, glucose, calcium, magnesium, phosphorus
  • liver function tests SGOT, SGPT, GGT, total bilirubin, albumin
  • WBC full blood count
  • RBC platelet count
  • the KSADS-PL was administered to each participant during the first visit.
  • the KSADS-PL is a structured diagnostic interview used to assess current functioning and to determine whether participants met study inclusion criteria, including absence of a lifetime Axis I or Axis II psychiatric disorder both currently and lifetime. None of the 75 participants who completed the study met criteria for any past or current Axis I or II disorder.
  • the CDRS is an investigator-administered scale that is widely used as observational measures of depressive symptoms in children.
  • the scale was
  • the CPT is a test of sustained attention that has been adapted for computerized administration.
  • the test requires participants to attend vigilantly to a series of target and distracter stimuli for a 14-minute duration. Attention scores include reaction time, omission errors during which the participant should have responded but did not, and commission errors during which the participant failed to inhibit a response.
  • the CPT was administered at all three visits.
  • the MOSES is a scale designed to assess common symptoms or adverse events associated with psychopharmacological medications. This scale is divided into nine body areas representing a typical physical examination. The interviewer asks subjects whether they have each symptom on the measure and, if so, asks them to report the level of severity of the symptom on a scale from 0 (not present) to 4 (severe). This scale was administered on the second and third visits to assess presence or absence of adverse events.
  • the Placebo group showed no improvement between visit 1 and visit 3 on
  • the Exercise/Lifestyle Questionnaire included four summary categories (Exercise, Appetite, Smoke, and Alcohol), each of which consisted of multiple individual items. Within and between group analyses are reported below for each of the summary categories.
  • the 500 mg/day group showed significant increases in scores between visit 1 and visit 3 on mean dominant hand (p ⁇ 0.01) and the mean non-dominant hand (p ⁇ 0.01) (Table 60).
  • the Placebo group showed significant differences between visit 1 and visit 3 on the total speed score ( ⁇ 0.01), total accuracy score ( ⁇ 0.01), and total difference score
  • the 500 mg/day group showed significant differences between visit 1 and visit 3 on the total speed score (p ⁇ 0.01), total accuracy score (p ⁇ 0.01), speed difference score
  • PANAS-C Visit 1 to Visit 3 250 mg/day group
  • PANAS-C Visit 1 to Visit 3 500 mg/day group
  • PANAS-C Visit 3 and Visit Difference Scores 250 mg/day group and 500 mg/day roup
  • PANAS-C Visit 3 250 mg/day, Placebo groups, and 500 mg/day groups
  • CDRS Visit Difference Scores 250 mg/day, Placebo groups, and 500 mg/day groups
  • V3-V1 Total -1.04 6.43 -1.42 7.05 .85
  • BIS Visit 3 250 mg/day, Placebo groups, and 500 mg/day groups
  • ARS Visit 3 250 mg/day, Placebo groups, and 500 mg/day groups
  • PSQI Visit 3 and Visit Difference Scores 250 mg/day group and 500 mg/day group
  • PSQI Visit 3 250 mg/day, Placebo groups, and 500 mg/day groups
  • PSQI Visit Difference Scores 250 mg/day, Placebo groups, and 500 mg/day
  • Finger Tap Test Visit 3 250 mg/day, Placebo groups, and 500 mg/day groups
  • CVLT I & II Visit 3 250 mg/day, Placebo, and 500 mg/day groups
  • CVLT Visit Difference Scores 250 mg/day, Placebo, and 500 mg/day groups
  • ROCFT Visit 1 to Visit 3 500 mg/day group
  • Stroop Visit 3 250 mg/day, Placebo, and 500 mg/day groups
  • Stroop Visit Difference Scores 250 mg/day, Placebo, and 500 mg/day groups
  • CPT Visit 3 250 mg/day, Placebo, and 500 mg/day groups
  • Trail Making Test Visit 1 to Visit 3 500 mg/day group Table 107
  • Trail Making Test Visit 3 250 mg/day, Placebo, and 500 mg/day groups
  • Trail Making Test Visit Difference Scores 250 mg/day, Placebo, and 500 mg/day

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Physiology (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
PCT/IB2015/053178 2014-04-30 2015-04-30 Administration of citicoline to improve cognitive performance, attentional performance, and motor function Ceased WO2015166463A1 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
US15/307,411 US11583546B2 (en) 2014-04-30 2015-04-30 Administration of citicoline to improve cognitive performance, attentional performance, and motor function
EP15786597.3A EP3137067B1 (en) 2014-04-30 2015-04-30 Citicoline to improve motor function
JP2016564605A JP6584430B2 (ja) 2014-04-30 2015-04-30 認知パフォーマンス、注意パフォーマンス、及び運動機能を改善するためのシチコリン投与
ES15786597T ES2915909T3 (es) 2014-04-30 2015-04-30 Citicolina para mejorar la función motora
PL15786597T PL3137067T3 (pl) 2014-04-30 2015-04-30 Cytykolina poprawiająca funkcje motoryczne
AU2015254865A AU2015254865B2 (en) 2014-04-30 2015-04-30 Administration of citicoline to improve cognitive performance, attentional performance, and motor function
CA2947252A CA2947252C (en) 2014-04-30 2015-04-30 Administration of citicoline to improve cognitive performance, attentional performance, and motor function
NZ725643A NZ725643B2 (en) 2014-04-30 2015-04-30 Administration of citicoline to improve cognitive performance, attentional performance, and motor function
US18/069,325 US12115181B2 (en) 2014-04-30 2022-12-21 Administration of citicoline to improve cognitive performance, attentional performance, and motor function

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201461986502P 2014-04-30 2014-04-30
US61/986,502 2014-04-30

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US15/307,411 A-371-Of-International US11583546B2 (en) 2014-04-30 2015-04-30 Administration of citicoline to improve cognitive performance, attentional performance, and motor function
US18/069,325 Continuation US12115181B2 (en) 2014-04-30 2022-12-21 Administration of citicoline to improve cognitive performance, attentional performance, and motor function

Publications (1)

Publication Number Publication Date
WO2015166463A1 true WO2015166463A1 (en) 2015-11-05

Family

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Family Applications (1)

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PCT/IB2015/053178 Ceased WO2015166463A1 (en) 2014-04-30 2015-04-30 Administration of citicoline to improve cognitive performance, attentional performance, and motor function

Country Status (8)

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US (2) US11583546B2 (enExample)
EP (1) EP3137067B1 (enExample)
JP (1) JP6584430B2 (enExample)
AU (1) AU2015254865B2 (enExample)
CA (1) CA2947252C (enExample)
ES (1) ES2915909T3 (enExample)
PL (1) PL3137067T3 (enExample)
WO (1) WO2015166463A1 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100041621A1 (en) * 2008-08-15 2010-02-18 Perry Renshaw Methods and compositions for improving cognitive performance
JP6584430B2 (ja) 2014-04-30 2019-10-02 協和発酵バイオ株式会社 認知パフォーマンス、注意パフォーマンス、及び運動機能を改善するためのシチコリン投与

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020198172A1 (en) 1997-12-01 2002-12-26 Sandage Bobby W. Method of treating motor neuron diseases and demyelinating diseases with citicoline
US20070004670A1 (en) 1998-07-31 2007-01-04 Richard Wurtman Compositions containing citicoline, and methods of use thereof
WO2014069667A1 (en) 2012-10-30 2014-05-08 Kyowa Hakko Bio Co., Ltd. Agent for preventing or improving decline in brain function

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030114415A1 (en) * 2001-12-14 2003-06-19 Wurtman Richard J. Compositions and methods for treating and preventing memory impairment using citicoline
CA2517290A1 (en) * 2003-02-26 2004-09-10 Kyowa Hakko Kogyo Co., Ltd. Muscle-building agent and preventive or remedy for muscle weakening
US20070248696A1 (en) * 2006-04-25 2007-10-25 Mind Sports Nutrition Inc. Composition and method for enhancing neuromuscular facilitation and cognitive functions
US20100041621A1 (en) * 2008-08-15 2010-02-18 Perry Renshaw Methods and compositions for improving cognitive performance
US20100041620A1 (en) * 2008-08-15 2010-02-18 Perry Renshaw Methods for improving frontal brain bioenergetic metabolism
US9883831B1 (en) * 2014-01-30 2018-02-06 Texas Health Biomedical Advancement Center, Inc. Digital medical evaluation and testing on a touch screen device
JP6584430B2 (ja) 2014-04-30 2019-10-02 協和発酵バイオ株式会社 認知パフォーマンス、注意パフォーマンス、及び運動機能を改善するためのシチコリン投与

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020198172A1 (en) 1997-12-01 2002-12-26 Sandage Bobby W. Method of treating motor neuron diseases and demyelinating diseases with citicoline
US20070004670A1 (en) 1998-07-31 2007-01-04 Richard Wurtman Compositions containing citicoline, and methods of use thereof
WO2014069667A1 (en) 2012-10-30 2014-05-08 Kyowa Hakko Bio Co., Ltd. Agent for preventing or improving decline in brain function

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
ALVAREZ X. ANTON ET AL.: "Citicoline improves memory performance in elderly subjects", METHODS FIND EXP CLIN PHARMACOL., vol. 19, no. 3, 1997, pages 201 - 10, XP055234026 *
See also references of EP3137067A4
SILVERI M. M. ET AL.: "Citicoline enhances frontal lobe bioenergetics as measured by phosphorus magnetic resonance spectroscopy", NMR BIOMED., vol. 21, no. 10, 2008, pages 1066 - 75, XP055234021 *
STEVEN E. BRUCE: "Improvements in quantitative EEG following consumption of a natural citicoline-enhanced beverage", INT J FOOD SCI NUTR., vol. 63, no. 4, 2012, pages 421 - 5, XP055360326 *
TOSHIMASA SATO ET AL.: "Time courses of brain activation and their implications for function: A multichannel near-infrared spectroscopy study during finger tapping", NEUROSCI RES., vol. 58, no. 3, 2007, pages 297 - 304, XP022149658 *

Also Published As

Publication number Publication date
US20170049796A1 (en) 2017-02-23
CA2947252C (en) 2022-05-10
JP6584430B2 (ja) 2019-10-02
AU2015254865B2 (en) 2020-07-02
US20230181614A1 (en) 2023-06-15
US12115181B2 (en) 2024-10-15
JP2017520513A (ja) 2017-07-27
EP3137067A1 (en) 2017-03-08
CA2947252A1 (en) 2015-11-05
NZ725643A (en) 2021-08-27
ES2915909T3 (es) 2022-06-27
PL3137067T3 (pl) 2022-06-27
EP3137067A4 (en) 2017-12-27
AU2015254865A1 (en) 2016-11-24
EP3137067B1 (en) 2022-05-04
US11583546B2 (en) 2023-02-21

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