JP6818331B2 - 軽度認知障害を治療又は予防するための組成物 - Google Patents
軽度認知障害を治療又は予防するための組成物 Download PDFInfo
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- 229910000359 iron(II) sulfate Inorganic materials 0.000 description 1
- SZVJSHCCFOBDDC-UHFFFAOYSA-N iron(II,III) oxide Inorganic materials O=[Fe]O[Fe]O[Fe]=O SZVJSHCCFOBDDC-UHFFFAOYSA-N 0.000 description 1
- 229960000310 isoleucine Drugs 0.000 description 1
- 229940113094 isopropylparaben Drugs 0.000 description 1
- 239000007951 isotonicity adjuster Substances 0.000 description 1
- 229960003136 leucine Drugs 0.000 description 1
- 125000002463 lignoceryl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 229960004488 linolenic acid Drugs 0.000 description 1
- KQQKGWQCNNTQJW-UHFFFAOYSA-N linolenic acid Natural products CC=CCCC=CCC=CCCCCCCCC(O)=O KQQKGWQCNNTQJW-UHFFFAOYSA-N 0.000 description 1
- 229960003646 lysine Drugs 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 239000001630 malic acid Substances 0.000 description 1
- 235000011090 malic acid Nutrition 0.000 description 1
- 150000004667 medium chain fatty acids Chemical class 0.000 description 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- WVJKHCGMRZGIJH-UHFFFAOYSA-N methanetriamine Chemical compound NC(N)N WVJKHCGMRZGIJH-UHFFFAOYSA-N 0.000 description 1
- 229960004452 methionine Drugs 0.000 description 1
- 125000000956 methoxy group Chemical group [H]C([H])([H])O* 0.000 description 1
- 229910052750 molybdenum Inorganic materials 0.000 description 1
- 239000011733 molybdenum Substances 0.000 description 1
- 125000002950 monocyclic group Chemical group 0.000 description 1
- RZRNAYUHWVFMIP-UHFFFAOYSA-N monoelaidin Natural products CCCCCCCCC=CCCCCCCCC(=O)OCC(O)CO RZRNAYUHWVFMIP-UHFFFAOYSA-N 0.000 description 1
- 125000002819 montanyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 239000003703 n methyl dextro aspartic acid receptor blocking agent Substances 0.000 description 1
- DUWWHGPELOTTOE-UHFFFAOYSA-N n-(5-chloro-2,4-dimethoxyphenyl)-3-oxobutanamide Chemical compound COC1=CC(OC)=C(NC(=O)CC(C)=O)C=C1Cl DUWWHGPELOTTOE-UHFFFAOYSA-N 0.000 description 1
- 125000003136 n-heptyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
- 235000010298 natamycin Nutrition 0.000 description 1
- 239000004311 natamycin Substances 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 229910052759 nickel Inorganic materials 0.000 description 1
- 125000002465 nonacosyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 239000006191 orally-disintegrating tablet Substances 0.000 description 1
- 229960003104 ornithine Drugs 0.000 description 1
- 235000006408 oxalic acid Nutrition 0.000 description 1
- 125000006353 oxyethylene group Chemical group 0.000 description 1
- 239000003002 pH adjusting agent Substances 0.000 description 1
- 229920001277 pectin Polymers 0.000 description 1
- 235000010987 pectin Nutrition 0.000 description 1
- 239000001814 pectin Substances 0.000 description 1
- 125000002460 pentacosyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 235000021317 phosphate Nutrition 0.000 description 1
- 150000003013 phosphoric acid derivatives Chemical class 0.000 description 1
- SHUZOJHMOBOZST-UHFFFAOYSA-N phylloquinone Natural products CC(C)CCCCC(C)CCC(C)CCCC(=CCC1=C(C)C(=O)c2ccccc2C1=O)C SHUZOJHMOBOZST-UHFFFAOYSA-N 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 239000010665 pine oil Substances 0.000 description 1
- 229920000656 polylysine Polymers 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 229940068965 polysorbates Drugs 0.000 description 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 1
- 229910000027 potassium carbonate Inorganic materials 0.000 description 1
- 235000011181 potassium carbonates Nutrition 0.000 description 1
- 235000011118 potassium hydroxide Nutrition 0.000 description 1
- 235000010241 potassium sorbate Nutrition 0.000 description 1
- 239000004302 potassium sorbate Substances 0.000 description 1
- 229940069338 potassium sorbate Drugs 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 229960002429 proline Drugs 0.000 description 1
- 239000001294 propane Substances 0.000 description 1
- 230000000069 prophylactic effect Effects 0.000 description 1
- 125000002572 propoxy group Chemical group [*]OC([H])([H])C(C([H])([H])[H])([H])[H] 0.000 description 1
- 235000019423 pullulan Nutrition 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 239000001397 quillaja saponaria molina bark Substances 0.000 description 1
- IUVKMZGDUIUOCP-BTNSXGMBSA-N quinbolone Chemical compound O([C@H]1CC[C@H]2[C@H]3[C@@H]([C@]4(C=CC(=O)C=C4CC3)C)CC[C@@]21C)C1=CCCC1 IUVKMZGDUIUOCP-BTNSXGMBSA-N 0.000 description 1
- 150000003254 radicals Chemical class 0.000 description 1
- 229960000342 retinol acetate Drugs 0.000 description 1
- QGNJRVVDBSJHIZ-QHLGVNSISA-N retinyl acetate Chemical compound CC(=O)OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C QGNJRVVDBSJHIZ-QHLGVNSISA-N 0.000 description 1
- 235000019173 retinyl acetate Nutrition 0.000 description 1
- 239000011770 retinyl acetate Substances 0.000 description 1
- 235000019192 riboflavin Nutrition 0.000 description 1
- 239000002151 riboflavin Substances 0.000 description 1
- 150000003287 riboflavins Chemical class 0.000 description 1
- 229930182490 saponin Natural products 0.000 description 1
- 150000007949 saponins Chemical class 0.000 description 1
- 229930195734 saturated hydrocarbon Natural products 0.000 description 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 description 1
- CDAISMWEOUEBRE-UHFFFAOYSA-N scyllo-inosotol Natural products OC1C(O)C(O)C(O)C(O)C1O CDAISMWEOUEBRE-UHFFFAOYSA-N 0.000 description 1
- 229910052711 selenium Inorganic materials 0.000 description 1
- 239000011669 selenium Substances 0.000 description 1
- 229940091258 selenium supplement Drugs 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229960001153 serine Drugs 0.000 description 1
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 description 1
- 235000012239 silicon dioxide Nutrition 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 229910000029 sodium carbonate Inorganic materials 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 229940080237 sodium caseinate Drugs 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 235000019259 sodium dehydroacetate Nutrition 0.000 description 1
- 229940079839 sodium dehydroacetate Drugs 0.000 description 1
- 235000011121 sodium hydroxide Nutrition 0.000 description 1
- JXKPEJDQGNYQSM-UHFFFAOYSA-M sodium propionate Chemical compound [Na+].CCC([O-])=O JXKPEJDQGNYQSM-UHFFFAOYSA-M 0.000 description 1
- 235000010334 sodium propionate Nutrition 0.000 description 1
- 239000004324 sodium propionate Substances 0.000 description 1
- 229960003212 sodium propionate Drugs 0.000 description 1
- 239000011781 sodium selenite Substances 0.000 description 1
- 229960001471 sodium selenite Drugs 0.000 description 1
- 235000015921 sodium selenite Nutrition 0.000 description 1
- DSOWAKKSGYUMTF-GZOLSCHFSA-M sodium;(1e)-1-(6-methyl-2,4-dioxopyran-3-ylidene)ethanolate Chemical compound [Na+].C\C([O-])=C1/C(=O)OC(C)=CC1=O DSOWAKKSGYUMTF-GZOLSCHFSA-M 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 235000010199 sorbic acid Nutrition 0.000 description 1
- 239000004334 sorbic acid Substances 0.000 description 1
- 229940075582 sorbic acid Drugs 0.000 description 1
- 235000019710 soybean protein Nutrition 0.000 description 1
- 229940032147 starch Drugs 0.000 description 1
- 235000003702 sterols Nutrition 0.000 description 1
- 150000003432 sterols Chemical class 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 1
- 235000019408 sucralose Nutrition 0.000 description 1
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- LSNNMFCWUKXFEE-UHFFFAOYSA-L sulfite Chemical class [O-]S([O-])=O LSNNMFCWUKXFEE-UHFFFAOYSA-L 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 238000002636 symptomatic treatment Methods 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 239000008399 tap water Substances 0.000 description 1
- 235000020679 tap water Nutrition 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 229960002898 threonine Drugs 0.000 description 1
- 229940113082 thymine Drugs 0.000 description 1
- 229910052718 tin Inorganic materials 0.000 description 1
- 239000011135 tin Substances 0.000 description 1
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 1
- 229940042585 tocopherol acetate Drugs 0.000 description 1
- 239000012929 tonicity agent Substances 0.000 description 1
- 229910021654 trace metal Inorganic materials 0.000 description 1
- 238000012549 training Methods 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 239000012581 transferrin Substances 0.000 description 1
- 229940121343 tricaprilin Drugs 0.000 description 1
- 125000002469 tricosyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 description 1
- VLPFTAMPNXLGLX-UHFFFAOYSA-N trioctanoin Chemical compound CCCCCCCC(=O)OCC(OC(=O)CCCCCCC)COC(=O)CCCCCCC VLPFTAMPNXLGLX-UHFFFAOYSA-N 0.000 description 1
- 229960004799 tryptophan Drugs 0.000 description 1
- 229960004441 tyrosine Drugs 0.000 description 1
- 125000002948 undecyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 229930195735 unsaturated hydrocarbon Natural products 0.000 description 1
- 229940035893 uracil Drugs 0.000 description 1
- 229960004295 valine Drugs 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 235000021470 vitamin B5 (pantothenic acid) Nutrition 0.000 description 1
- 235000019166 vitamin D Nutrition 0.000 description 1
- 239000011710 vitamin D Substances 0.000 description 1
- 150000003710 vitamin D derivatives Chemical class 0.000 description 1
- 150000003712 vitamin E derivatives Chemical class 0.000 description 1
- 235000019168 vitamin K Nutrition 0.000 description 1
- 239000011712 vitamin K Substances 0.000 description 1
- 150000003721 vitamin K derivatives Chemical class 0.000 description 1
- 229940045997 vitamin a Drugs 0.000 description 1
- 229940046008 vitamin d Drugs 0.000 description 1
- 229940046010 vitamin k Drugs 0.000 description 1
- 239000008215 water for injection Substances 0.000 description 1
- 235000021119 whey protein Nutrition 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
〔1〕 式I:
[式中
R1及びR2は、独立して、水素又は−COR3であり、ここで、R1及びR2は同時に−COR3ではなく、
R3は、炭素数1〜30の飽和又は不飽和の脂肪族炭化水素基であり、
Aは、−CH2−CH2−N+(CH3)3、−CH2−CH2−N+H3、−CH2−CH(NH2)(COO−)、又はC1−6アルキル、C1−6アルコキシ及び水酸基からなる群より選択される1〜6個の置換基で置換されていてもよいC3−6シクロアルキルである]
の構造を有する化合物と補助成分とを含む軽度認知障害を治療又は予防するための組成物であって、脳波解析システムを用いて軽度認知障害を有すると識別された被験体に、式Iの構造を有する化合物として1日あたり8〜60mg/kg体重を投与することを特徴とする、組成物。
〔2〕 R1が、水素であり、R2が、−COR3である、〔1〕に記載の組成物。
〔3〕 Aが、−CH2−CH2−N+(CH3)3である、〔1〕又は〔2〕に記載の組成物。
〔4〕 式Iの構造を有する化合物が、リゾレシチンである、〔1〕〜〔3〕のいずれかに記載の組成物。
〔5〕 リゾレシチンが、大豆由来リゾレシチンである、〔4〕に記載の組成物。
〔6〕 脳波解析システムを用いて軽度認知障害を有すると識別された被験体が、脳波解析システムNATESASにおいて、AD総合における類似性値が0超の被験体である、〔1〕〜〔5〕のいずれかに記載の組成物。
〔7〕 1質量部の式Iの構造を有する化合物に対して1〜16質量部の補助成分を含む、〔1〕〜〔6〕のいずれかに記載の組成物。
〔8〕 補助成分が、核酸、コラーゲン、ビタミンB1、ビタミンB2、ビタミンB6、ビタミンB12、ビタミンC、ナイアシン、パントテン酸、乳酸菌生産物質、ドコサヘキサエン酸及びエイコサペンタエン酸からなる群より選択される少なくとも1種を含む、〔1〕〜〔7〕のいずれかに記載の組成物。
また、本発明によれば、式Iの構造を有する化合物だけでなく補助成分を組成物に含有することで、式Iの構造を有する化合物単独では軽度認知障害を治療又は予防する効果がほとんどないか又は小さいにもかかわらず、軽度認知障害を治療又は予防する効果が顕著に高くなる。これは、脳細胞の必須栄養素となりうる式Iの構造を有する化合物に、他の栄養素となりうる補助成分を加えて複合栄養化することにより、脳細胞及び/又は脳組織の代謝が向上し、その結果として、認知症の改善が図られるものと推測される。
したがって、本発明によれば、我が国で社会問題化している認知症の根治的な治療等が可能となるから、超高齢社会化に伴う介護負担の増大や医療費増大に歯止めをかけることで、医療経済等にも資することができる。
[式中
R1及びR2は、独立して、水素又は−COR3であり、ここで、R1及びR2は同時に−COR3ではなく、
R3は、炭素数1〜30の飽和又は不飽和の脂肪族炭化水素基であり、
Aは、−CH2−CH2−N+(CH3)3、−CH2−CH2−N+H3、−CH2−CH(NH2)(COO−)、又はC1−6アルキル、C1−6アルコキシ及び水酸基からなる群より選択される1〜6個の置換基で置換されていてもよいC3−6シクロアルキルである]
の構造を有する化合物と補助成分とを含む軽度認知障害を治療又は予防するための組成物であって、脳波解析システムを用いて軽度認知障害を有すると識別された被験体に、式Iの構造を有する化合物として1日あたり8〜60mg/kg体重を投与することを特徴とする、組成物を提供する。
の構造を有する。
脳波からその脳波の特徴量を抽出した脳波特徴データに、当該脳波特徴データに対応する脳疾患の状態を示す疾患情報を付した学習データを複数取得し、前記複数の学習データを機械学習することにより、脳疾患の判定を行う評価モデルを算出する評価モデル算出部と、被験者の脳波特徴データを取得し、前記評価モデルに基づいて、前記被験者の脳波特徴データが示す脳疾患の判定を行う判定部と、を備え、前記評価モデル算出部は、前記複数の学習データそれぞれの脳波特徴データに含まれる複数の特徴量のうち、機械学習によって抽出された脳疾患の判定に有効な特徴量のみを用いて前記評価モデルを算出する脳疾患診断支援システム。
脳疾患診断支援装置は、被験者の脳波に基づいて被験者が認知症を患っている確率を提示するシステムである。脳疾患診断支援装置は、この機能を実現するプログラムを実行することができる、例えばPCやサーバ装置である。
脳疾患診断支援装置は、脳波特徴データ取得部、操作受付部、評価モデル算出部、判定部、記憶部、表示部、を備えている。
脳波特徴データ取得部は、被験者の脳波特徴データを取得することができる。脳波特徴データとは、被験者の脳波からその脳波の特徴量を抽出したデータである。脳波は、例えば、国際10−20法に基づいて被験者の頭部の所定の位置に配置された電極のうち、耳朶に配置された電極とそれ以外の電極との間の電位差の変動を記録したデータであってもよい。また、脳波の特徴量とは、例えば、電極を配置した位置ごとに測定した電位における複数の周波数帯それぞれにおける電位の2乗(sNAT)、隣接する周波数帯間でのsNATの比(脳波の滑らかさ)である。また、脳波特徴データ取得部は、脳波特徴データにその脳波特徴データがどのような脳疾患を持つ者の脳波特徴データであるかを示す疾患情報を付した学習データを取得することができる。
操作受付部は、オペレータの脳疾患診断支援装置への指示操作を受け付けることができる。指示操作とは、例えば、脳波特徴データの取り込みを指示する操作や、その脳波特徴データの評価を行うことを指示する操作等である。
評価モデル算出部は、脳波特徴データ取得部が取得した複数の学習データを機械学習することにより、脳疾患の判定に用いる評価モデルを算出することができる。例えば、複数の学習データを、各学習データに付された疾患情報の種類ごとに分離する境界情報を算出する。評価モデル算出部が用いる機械学習は、例えば、SVM(Support Vector Machine)であってもよい。境界情報とは、例えば、健常者の脳波特徴データとアルツハイマー型認知症を有する被験体の脳波特徴データを分離する分離境界面を示す関数であってもよい。
判定部は、被験者の脳波特徴データを取得し、評価モデル算出部が算出した評価モデルに基づいて、被験者の脳波特徴データが示す脳疾患の判定を行うことができる。例えば、学習データに基づいて評価モデル算出部が算出した境界情報に基づいて、ある被験者の脳波特徴データを評価することができる。評価とは、例えば、ある被験者の脳波特徴データが、複数の脳疾患のうち、どの脳疾患であるのかを判定したり、その被験者の脳波特徴データが判定した脳疾患であることを示す確率を算出したりすることである。
記憶部は、複数の被験者の脳波特徴データや、評価モデル算出部が算出した境界情報など、種々の情報を記憶することができる。
表示部は、判定部の評価結果を、脳疾患診断支援装置に接続された表示装置に出力することができる。
[式中
R1及びR2は、−COR3であり、
各R3は、独立して、炭素数1〜30の飽和又は不飽和の脂肪族炭化水素基であり、
Aは、−CH2−CH2−N+(CH3)3、−CH2−CH2−N+H3、−CH2−CH(NH2)(COO−)、又はC1−6アルキル、C1−6アルコキシ及び水酸基からなる群より選択される1〜6個の置換基で置換されていてもよいC3−6シクロアルキルである]
の構造を有する化合物を酵素(例えば、ホスホリパーゼA1、ホスホリパーゼA2、ホスホリパーゼB等)を作用させること等により調製してもよい。式0の構造を有する化合物は、例えば、市販されているものを用いてもよいし、大豆、卵黄等から従来のリン脂質抽出方法等により抽出したものを用いてもよい。なお、このようにして得た式Iの構造を有する化合物の含有量は、例えば、従来のリン脂質定量法等により定量してもよい。
大豆原油を濾過し、ついで、約60℃〜約80℃に加温した状態で水を加えて攪拌した後、沈殿した含水ガム質から成る沈殿部を遠心分離によって分離することができる。その後、得られた含水ガム質を減圧下において加熱・乾燥することによって、リン脂質分:約60〜約65重量%、中性脂肪:約35〜約40重量%および微量の遊離脂肪酸とステロール類とからなる式0の構造を有する化合物を含むペースト状組成物を製造することができる。次に、このペースト状組成物に水を加えた後、ホスホリパーゼA1及び/又はA2を作用させて、各リン脂質の所定の脂肪酸エステル部分を加水分解する。そして、この反応の終了後に、加温等により酵素を失活させ、更に、減圧下において加熱・乾燥した後、濾過を行うことで、式Iの構造を有する化合物を混合物として調製することができる。
或いは、加熱乾燥した大豆を粉砕・圧縮することにより大豆油を得、これを上述した酵素を用いて分解し、必要に応じて、精製・濾過等をすることにより、式Iの構造を有する化合物を混合物として調製することができる。
式Iの構造を有する化合物、賦形剤、崩壊剤、結合剤等を混合し、水と共に造粒する。得られた顆粒を乾燥し、該顆粒を必要に応じて粉砕する。そして、これに滑沢剤等を加えて更に混合し、これを圧縮成形することで錠剤を得ることができる。
式Iの構造を有する化合物、賦形剤等を混合し、これに滑沢剤等を加え、更に混合する。そして、得られた混合物を硬カプセル(例えば、ゼラチン性のカプセル等)に充填することで、硬カプセル剤を得ることができる。
式Iの構造を有する化合物、賦形剤等を混合して得られたカプセル内容物を、公知のカプセル充填装置を用いて被膜内に充填することで、軟カプセル剤を得ることができる。
式Iの構造を有する化合物、賦形剤、ゲル化剤、乳化剤等を混合する。得られた混合物を型枠に充填して冷却固化することで、ゼリー剤を得ることができる。
賦形剤及びゲル化剤等を混合し、ここに、式Iの構造を有する化合物、ゲル化剤等を加え、更に混合する。次に、必要に応じて、更に賦形剤等を加えた後、所望の型に流し込み、冷却固化等することにより、グミ剤を得ることができる。
式Iの構造を有する化合物、溶剤等を混合することで、液剤を得ることができる。
被験体に脳波計を取り付けて脳波を測定し、得られた脳波データをVPN回線等により脳波解析システムNATESASに送り、脳波データを解析してもよい。脳波解析システムNATESASによって解析されたデータをVPN回線等により受けとり、解析により得られたAD総合における類似性値が0超の場合、被験体は、軽度認知障害と識別されてもよい。或いは、脳波解析システムNATESASによって解析された被験体の脳波のカラーマップと、脳波解析システムNATESAS上に構築されている健常者及び/又はアルツハイマー症患者等の脳波のカラーマップとを比較することで、被験体は、軽度認知障害と識別されてもよい。
軽度認知障害と識別された被験体に、本発明の組成物を例えば1日1〜3回摂取(好ましくは、経口摂取)させ、例えば、初回の摂取の約10分後、約20分後、約30分後、約40分後、約50分後、約1時間後、約2時間後、約4時間後、約6時間後、約12時間後、約1日後、約2日後、約3日後、約4日後、約5日後、約6日後、約1週間後、約2週間後、約1か月後、約2か月後、約3か月後、約6か月後、約1年後に同様に脳波を測定し、CL1〜CL4及びAD総合における類似性値を得ることができる。本発明の組成物を摂取する前に0超であったAD総合における類似性値が、本発明の組成物の摂取により値が低下した場合(好ましくは、0以下になった場合)、軽度認知障害を治療又は予防する効果があると判断してもよい。
ステンレス製容器に、63.9質量部の水を入れ、16.7質量部の賦形剤(ブドウ糖果糖液糖及びメープルシロップを含む)及びゲル化剤を加え、均一になるまで約75〜90℃で撹拌した。ここに、0.5質量部の乳化剤と0.06質量部の大豆由来リゾレシチン(式Iの構造を有する化合物)とを加えて混合した後、14.94質量部の果汁(マンゴー果汁及びリンゴ果汁を含む)、0.25質量部のクエン酸、1質量部の香料及び2.65質量部の賦形剤を加え、更に撹拌することで、実施例1の組成物(ゼリー剤)を得た(ゼリー剤 10g中、式Iの構造を有する化合物 0.6g)。
ステンレス製容器に、80質量部の賦形剤(水あめ、還元水あめ及びブドウ糖を含む)を入れ、約75〜90℃に加熱した後、約75〜90℃の少量の水で溶液状としたゼラチンを混合し、撹拌した。ここに、0.072質量部の乳化剤と、9.375質量部の大豆由来リゾレシチン(式Iの構造を有する化合物)とを加え、更に混合した。次に、0.641質量部の果汁(リンゴ果汁を含む)、2.152質量部のクエン酸、0.092質量部の香料及び0.467質量部のデンプンを加え、均一になるまで混合し、これを半球状の型枠に充填して冷却固化することで、実施例2の組成物(グミ剤)を得た(3.2g/1粒、式Iの構造を有する化合物 0.3g/1粒)。
47.2質量部の大豆由来リゾレシチン(式Iの構造を有する化合物)と52.8質量部のベニバナ油とを混合し、カプセル内容物を得た。次に、上記で得たカプセル内容物を、既存のロータリーダイ式カプセル成形装置を用いて被膜(グリセリン、ゼラチン及びカラギーナンを含む)内に充填し、実施例3の組成物(軟カプセル剤)を得た(0.53g/1粒、式Iの構造を有する化合物 0.25g/1粒)。
75.7質量部の大豆由来リゾレシチン(式Iの構造を有する化合物)、20.5質量部のベニバナ油及び3.8質量部の亜麻人油を混合し、実施例4の組成物(液剤)を得た(液剤 1.5g中、式Iの構造を有する化合物 1.136g)。
表1に示す背景を有する被験者3名を対象に、本発明の組成物の軽度認知障害に対する有効性を評価した。なお、被験者3名はいずれも、医師による問診の結果、認知症ではないと診断された。
各被験者の脳波を脳波計(日本光電工業株式会社製)で測定し(使用した電極:21極)、得られた脳波データを脳波解析システムNATESAS(登録商標)(医療機器認証番号:228AHBZX00042000)によって解析した(「摂取前」)。この解析により得られた、AD総合が0超である場合、軽度認知障害を有すると識別した。以下の表2〜4における摂取前の類似性値から明らかなように、被験者1〜3は、軽度認知障害を有すると識別された。
次に、軽度認知障害を有すると識別された被験者1〜3に、実施例1の組成物を2包(18.8g、式Iの構造を有する化合物として1.2g;即ち、式Iの構造を有する化合物として約17〜約20mg/kg体重)経口摂取させ、摂取40分後に脳波を脳波計で測定し、得られた脳波データを脳波解析システムNATESASによって解析した(「摂取40分後」)。更に、被験者1〜3において、軽度認知障害を有すると識別された翌日から、1日3回(朝、昼、夜)、1回あたり実施例1の組成物を1〜2包、1日あたり計4包(37.6g、式Iの構造を有する化合物として2.4g;即ち、式Iの構造を有する化合物として約34〜約41mg/kg体重)、約1か月間継続的に経口摂取させ、再度脳波を測定した(「摂取1か月後」)。結果を表2〜4及び図2A〜4Bに示す。
表3から明らかなように、被験者2においては、経口摂取前に0超であったAD総合及びCL4の類似性値が、本発明の組成物を経口摂取した40分後に0以下となった。また、経口摂取前及び摂取40分後に0超であったCL1の類似性値が、本発明の組成物を約1か月間継続して経口摂取した後に0以下となった。
表4から明らかなように、被験者3においては、経口摂取前及び摂取40分後に0超であったCL3の類似性値が、本発明の組成物を約1か月間継続して経口摂取した後に0以下となった。また、経口摂取前と比較して、摂取40分後及び摂取1か月後において、AD総合の数値が下がった。
Claims (7)
- 式I:
[式中
R1及びR2は、独立して、水素又は−COR3であり、ここで、R1及びR2は同時に−COR3ではなく、
R3は、炭素数1〜30の飽和又は不飽和の脂肪族炭化水素基であり、
Aは、−CH2−CH2−N+(CH3) 3 である]
の構造を有する化合物と補助成分とを含む軽度認知障害を治療するための組成物であって、脳波解析システムを用いて軽度認知障害を有すると識別された被験体に、式Iの構造を有する化合物として1日あたり8〜60mg/kg体重を投与することを特徴とし、該被験体の脳波を健常者の脳波に近づけるか又は戻すことが可能な、組成物。 - R1が、水素であり、R2が、−COR3である、請求項1に記載の組成物。
- 式Iの構造を有する化合物が、リゾレシチンである、請求項1又は2に記載の組成物。
- リゾレシチンが、大豆由来リゾレシチンである、請求項3に記載の組成物。
- 脳波解析システムを用いて軽度認知障害を有すると識別された被験体が、脳波解析システムNATESASにおいて、AD総合における類似性値が0超の被験体である、請求項1〜4のいずれか一項に記載の組成物。
- 1質量部の式Iの構造を有する化合物に対して1〜16質量部の補助成分を含む、請求項1〜5のいずれか一項に記載の組成物。
- 補助成分が、核酸、コラーゲン、ビタミンB1、ビタミンB2、ビタミンB6、ビタミンB12、ビタミンC、ビタミンE、ナイアシン、パントテン酸、乳酸菌生産物質、ドコサヘキサエン酸及びエイコサペンタエン酸からなる群より選択される少なくとも1種を含む、請求項1〜6のいずれか一項に記載の組成物。
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