JP2018030804A - Recognition function reduction inhibitor formed of hydrogen gas - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a recognition function reduction inhibitor.SOLUTION: There are provided a recognition function reduction inhibitor for inhibiting reduction of a recognition function due to aging containing hydrogen gas, a recognition function reduction inhibitor for inhibiting reduction of a recognition function due to aging formed of hydrogen gas, and a cognitive impairment inhibitor for inhibiting a cognitive impairment containing loss of memory, Alzheimer disease and blood vessel dementia containing hydrogen gas. In an opening label preliminary experiment, an effect which is given to a cognitive function of women aged 65 and older by suction of hydrogen gas for four weeks, is analyzed. As a result, a recognition function marker of a group of women aged 65 and older who appear to be well, is improved. The hydrogen gas may be a medicament useful for maintaining health of recognition force related to age.SELECTED DRAWING: None

Description

  The present invention relates to a cognitive function deterioration inhibitor made of hydrogen gas.

1. Introduction Cognitive decline is accompanied by aging, which is one of the most noticeable and difficult to control features of aging. Various pharmacological and non-pharmacological measures have been used to tackle cognitive impairment related to old age, where clinically mixed results are mixed. Hydrogen molecule (H ₂ ) is a new biomedical gas with multifunctional and therapeutic properties. H ₂ has recently been reported to relieve cognitive impairment and neurodegeneration in some animal models, but previous studies have not evaluated its effectiveness in clinical trials. In this open label preliminary experiment, we analyzed the effect of 4 weeks of H ₂ inhalation on cognitive function in women over 65 years of age.

2. Materials and Methods Participants (n = 13) who volunteered to participate in this open label preliminary experiment (registered in ClinicalTrials.gov, NCT02830854) were elderly women (68.0 ± 3.0 years old) The body weight was 66.9 ± 10.3 kg and the height was 161.1 ± 5.8 cm. Exclusion criteria include serious illness or psychotic complications. The survey was conducted in accordance with the guidelines of the Declaration of Helsinki, and the local IRB approved the survey protocol. All participants were required to submit informed consent, maintain a normal lifestyle during the study, and continue normal dietary intake. Participants inhaled H ₂ for 15 minutes per day for 4 weeks. H ₂ gas (4%) was provided by a biological gas supply device (MIZ Corporation, Kanagawa, Japan), and a research inspector monitored for daily H ₂ inhalation during the trial. The primary measure of treatment efficacy from baseline to week 4 was the change in the Mini Mental State Exam (MMSE) score. In addition, other cognitive markers and side effects were assessed at baseline and 4 weeks after the start of the study. Participants' cognitive function was assessed using the MMSE and Alzheimer's Disease Scale Subscale (ADAS-Cog). MMSE is a 30-point questionnaire survey that is used extensively in clinical and research environments to determine the degree of cognitive impairment in the elderly. ADAS-Cog is a cognitive test device consisting of 11 tasks, which determines memory impairment, language impairment, execution disorder, lack of attention, and other cognitive powers for dementia testing. In addition to the tests described above, participants were required to report adverse events of H2 intervention during the study period through a self-reported, open-ended questionnaire survey of side effects (eg nausea, headache). The Wilcoxon signed rank test was used to establish whether there was a significant difference between participant responses during the intervention period (baseline versus post-dose). Significance P ≦ 0.05 was set.

3. Results All participants completed the follow-up procedure. In other words, it was also reported side effects of H ₂ intervention. None were excluded from the study due to adverse events. The compliance rate for living regulations was 95.8%. Table 1 shows changes in cognitive function during the study (baseline vs. 4 weeks follow-up).

H ₂ intervention significantly increased the MMSE total score (mean 13.7%, P <0.01), thereby tracking from mild dementia at baseline (25.6 out of 30) Cognitive function improved to normal cognitive ability at the time of the survey (score higher than cut score 27). Furthermore, inhalation of H ₂ significantly improved the ADAS-Cog score, improved performance in the word reproduction test (P <0.01), and improved word recognition after administration (P = 0.01). . The other nine areas in the ADAS-Cog score (name-calling work, command, structural execution, thought execution, orientation, conversational ability, test command memory, spoken disabilities, comprehension) were performed correctly during both tests ( For example, score = 0) (not disclosed).

4). In consideration humans first administration, in the open-label clinical trial to investigate the efficacy of H ₂ on cognitive performance in the elderly, for 15 minutes every day for four weeks, by inhaling the H ₂ gas, women over the 65-year-old looks healthy The cognitive markers of the population improved. After dosing, 12 women (out of 13) had higher MMSE scores, and ADAS-Cog tests after H ₂ intervention reported improved word recognition. Furthermore, there were no signs of subjectively reported side effects from inhalation of H ₂ and it was considered acceptable safety. Since this preliminary experiment is considered to confirm the results of previous animal studies, it is considered that H ₂ gas is a useful drug in order to maintain cognitive health related to age. Cognitive impairment seems to be closely related to oxidative stress in the elderly. Since exogenous H ₂ acts as a selectively acting antioxidant, it helps maintain or restore the redox reaction balance in the central nervous system, thus extending the cognitive life. According to Nagata et al., Consumption of H ₂ reduced brain oxidative stress, preventing hippocampal-dependent learning and memory processing decline in mice caused by oxidative stress. Accordingly, the randomized controlled trial, other cognitive markers during intervention (e.g., the brain functional image analysis, based biomarkers cerebrospinal fluid and blood) by monitoring, H ₂ gas, only large sample Rather, it was confirmed that it actually creates the power to improve human cognition. If efficacy and safety are proven in well-designed clinical trials, H2 gas should be considered as an innovative treatment for cognitive impairment such as memory loss, Alzheimer's disease, and vascular dementia Can do.

Claims (3)

  An inhibitor of cognitive function deterioration caused by aging, including hydrogen gas.   An inhibitor of cognitive function deterioration caused by aging consisting of hydrogen gas.   A cognitive impairment inhibitor including memory loss, Alzheimer's disease, and vascular dementia, comprising hydrogen gas.