JP2018172423A5 - - Google Patents
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- JP2018172423A5 JP2018172423A5 JP2018129003A JP2018129003A JP2018172423A5 JP 2018172423 A5 JP2018172423 A5 JP 2018172423A5 JP 2018129003 A JP2018129003 A JP 2018129003A JP 2018129003 A JP2018129003 A JP 2018129003A JP 2018172423 A5 JP2018172423 A5 JP 2018172423A5
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- JP
- Japan
- Prior art keywords
- inhibitor
- cognitive function
- decline
- impairment
- cognitive
- Prior art date
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- 230000003920 cognitive function Effects 0.000 claims description 8
- 239000003112 inhibitor Substances 0.000 claims description 7
- 230000002401 inhibitory effect Effects 0.000 claims description 7
- UFHFLCQGNIYNRP-UHFFFAOYSA-N hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims description 5
- 206010001897 Alzheimer's disease Diseases 0.000 claims description 3
- 206010057668 Cognitive disease Diseases 0.000 claims description 3
- 230000032683 aging Effects 0.000 claims description 3
- 239000007789 gas Substances 0.000 claims description 3
- 206010027175 Memory impairment Diseases 0.000 claims description 2
- 201000004810 vascular dementia Diseases 0.000 claims description 2
- 239000004480 active ingredient Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 description 2
- 230000001149 cognitive Effects 0.000 description 2
- 230000004044 response Effects 0.000 description 2
- 231100000486 side effect Toxicity 0.000 description 2
- 230000001629 suppression Effects 0.000 description 2
- 208000000044 Amnesia Diseases 0.000 description 1
- 206010012289 Dementia Diseases 0.000 description 1
- 206010019233 Headache Diseases 0.000 description 1
- 206010028813 Nausea Diseases 0.000 description 1
- 206010061920 Psychotic disease Diseases 0.000 description 1
- 206010041466 Speech disease Diseases 0.000 description 1
- 231100000494 adverse effect Toxicity 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 235000012631 food intake Nutrition 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000003340 mental Effects 0.000 description 1
- 230000001225 therapeutic Effects 0.000 description 1
Description
本明細書を以下の発明の記載を包含する。
（１）水素ガスを含む加齢に起因する認識機能の低下抑制剤。
（２）水素ガスからなる加齢に起因する認識機能の低下抑制剤。
（３）水素ガスを含む、記憶喪失、アルツハイマー病、及び血管性認知症を含む認知障害抑制剤。
２．マテリアルと方法
本オープンラベル予備実験(ClinicalTrials.gov、NCT02830854に登録済)への参加を志願した参加者(ｎ＝１３)は、地域社会に住む老齢の女性(６８．０±３．０歳、体重６６．９±１０．３kg、身長１６１．１±５．８cm)であった。除外基準としては、重篤な疾病か精神病併発症がある。本調査は、ヘルシンキ宣言のガイドラインに準拠して実行され、地元のＩＲＢが本調査プロトコルを承認した。参加者は全員、インフォームドコンセントを提出し、調査中は通常のライフスタイルを維持し、通常の食事摂取を続けるように要求された。参加者は、４週間に渡って１日当たり１５分間、Ｈ２を吸入した。Ｈ２ガス(４％)は、生物学的ガス供給装置(日本国神奈川県のＭＩＺ株式会社)から提供され、治験中、研究査察官が日々のＨ２吸入について監視した。ベースラインから４週目までの期間の治療効能の主要評価指標は、ミニメンタルステート検査（Mini Mental State Exam、ＭＭＳＥ)スコアの変化であった。さらに、他の認識力マーカーの検査と副作用の評価を、ベースラインと、調査開始から４週間後に行なった。参加者の認知機能は、ＭＭＳＥとアルツハイマー病検査尺度のサブスケール(ADAS-Cog)を使って評価された。ＭＭＳＥは、高齢者の認知障害度を判断するために臨床・調査環境で広範囲に使われる３０ポイント・アンケート調査である。ADAS-Cogは、11個のタスクから成る認識力検査装置であり、認知症の検査のために、記憶障害、言語障害、実行障害、注意力欠如、その他の認識力を判断するものである。上述の検査に加えて、参加者は、副作用(例えば、吐気、頭痛)の自己申告・自由回答式アンケート調査によって、調査期間中、H2インターベンションの有害事象を報告するように要求された。ウィルコクソンの符号順位検定を使って、インターベンションの期間に参加者の応答の間に有意な差があるかどうかを確証した(ベースライン対投与後)。有意度Ｐ≦０．０５に設定された。
This specification includes the description of the following invention.
(1) An inhibitor of decline in cognitive function caused by aging including hydrogen gas.
(2) An agent for suppressing deterioration in cognitive function caused by aging, which comprises hydrogen gas.
(3) An agent for suppressing cognitive impairment including memory loss, Alzheimer's disease, and vascular dementia, including hydrogen gas.
2. Materials and Methods Participants (n = 13) who volunteered to participate in this open label pilot study (registered with ClinicalTrials.gov, NCT 02830854) are elderly women (68.0 ± 3.0 years old, who live in the community). It was 66.9 ± 10.3 kg in weight and 161.1 ± 5.8 cm in height. Exclusion criteria include serious illness or psychotic complications. The study was conducted in accordance with the guidelines of the Helsinki Declaration and the local IRB approved the study protocol. All participants provided informed consent and were required to maintain their normal lifestyle during the study and to continue normal food intake. Participants inhaled H 2 for 15 minutes a day for 4 weeks. H2 gas (4%) is provided by a biological gas supply apparatus (Kanagawa, Japan in MIZ Ltd.), during the study, research inspectors were monitored for daily H 2 inhalation. The primary measure of therapeutic efficacy from baseline to week 4 was the change in Mini Mental State Exam (MMSE) score. In addition, testing of other cognitive markers and assessment of side effects were performed at baseline and 4 weeks after the start of the study. Participant cognitive function was assessed using the MMSE and the Alzheimer's disease test subscale (ADAS-Cog). MMSE is a 30-point questionnaire survey that is used extensively in clinical and research settings to determine cognitive impairment in older people. The ADAS-Cog is an 11 task recognition test apparatus that determines memory impairment, speech disorder, performance impairment, attention deficit, and other cognitive skills for dementia testing. In addition to the tests described above, participants were required to report adverse events of H2 interventions during the study period by self-reporting / free-response questionnaires of side effects (eg, nausea, headache). Wilcoxon's signed rank test was used to establish whether there was a significant difference between participants' responses during the intervention period (baseline vs. post dose). The significance level was set to P ≦ 0.05.
Claims (4)
吸入によるヒトへの投与において用いられるための、認知機能の低下の抑制剤。 An inhibitor of deterioration of human cognitive function caused by aging, which contains hydrogen gas as an active ingredient ,
An inhibitor of cognitive decline for use in human administration by inhalation .
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2018129003A JP6762620B2 (en) | 2018-07-06 | 2018-07-06 | Cognitive decline inhibitor consisting of hydrogen gas |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2018129003A JP6762620B2 (en) | 2018-07-06 | 2018-07-06 | Cognitive decline inhibitor consisting of hydrogen gas |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016163322A Division JP6395774B2 (en) | 2016-08-24 | 2016-08-24 | Cognitive function depressant comprising hydrogen gas |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2018172423A JP2018172423A (en) | 2018-11-08 |
| JP2018172423A5 true JP2018172423A5 (en) | 2019-07-18 |
| JP6762620B2 JP6762620B2 (en) | 2020-09-30 |
Family
ID=64108277
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018129003A Active JP6762620B2 (en) | 2018-07-06 | 2018-07-06 | Cognitive decline inhibitor consisting of hydrogen gas |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP6762620B2 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2024024985A1 (en) * | 2022-07-29 | 2024-02-01 | 博久 小野 | Hydrogen-gas-containing drug for causal treatment of alzheimer's disease (disease-modifying drug) |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2009114084A (en) * | 2007-11-02 | 2009-05-28 | Shigeo Ota | Neurogenesis promoting composition containing hydrogen molecule |
| TWI602585B (en) * | 2014-03-25 | 2017-10-21 | 林信湧 | Inhalation-type pharmaceutical composition for alzheimer's disease and preparation method thereof |
| WO2018012596A1 (en) * | 2016-07-13 | 2018-01-18 | 株式会社マイトス | Composition for prevention or treatment of mild cognitive impairment or dementia containing hydrogen as active ingredient |
| JP6395774B2 (en) * | 2016-08-24 | 2018-09-26 | ＭｉＺ株式会社 | Cognitive function depressant comprising hydrogen gas |
-
2018
- 2018-07-06 JP JP2018129003A patent/JP6762620B2/en active Active
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