Cognitive function level testing kit and testing method

Abstract

To provide a kit and a method for testing easily a cognition function level by an olfactory test.SOLUTION: A cognition function level can be determined easily according to a response content from a subject in an olfactory test, by using two or more kinds of perfume liquids, one or more choice sheets for showing multiple choices containing a correct answer for each perfume, and a determination sheet for showing correct answer contents and a score given according to correctness of the answers, and also showing an index of the cognition function level according to the total score.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to a kit and method for conveniently testing the level of cognitive function through an olfactory test. [Background technology]

[0002] In recent years, as the aging of society continues to progress, the number of dementia patients is steadily increasing. Furthermore, Japan is also implementing a national policy called the Dementia Measures Promotion Principles, and it is necessary to address dementia as a social issue. In this context, there is no specific cure for dementia, and prevention is a more important issue than treatment. In addition, since it is known that the progression of dementia can be slowed by early preventive intervention, it would be extremely meaningful if the risk could be identified at a stage before clinical symptoms such as cognitive decline begin to appear.

[0003] On the other hand, it is known that the cognitive function level can be tested by an olfactory test because a decline in the cognitive function level is accompanied by a decline in the olfactory function (e.g., Non-Patent Document 1). However, conventionally, kits and methods for easily testing the cognitive function level by an olfactory test have not been sufficiently studied. [Prior art documents] [Non-patent literature]

[0004] [Non-Patent Document 1] Sayaka Katsunuma, The Journal of Japanese Nose, 53(1), pp. 73-74, 2014 Summary of the Invention [Problem to be solved by the invention]

[0005] An object of the present invention is to provide a kit and method for easily testing the level of cognitive function through an olfactory test. [Means for solving the problem]

[0006] The present inventors have conducted intensive research to solve the above problems, and have found that it is possible to easily determine the cognitive function level according to the answers given by a subject in an olfactory test by using two or more flavor liquids, a choice sheet showing multiple choices including a correct answer for each flavor liquid, and a judgment sheet showing the correct answers for each flavor liquid and a score given according to whether the answers are correct or incorrect, and showing an index of the cognitive function level according to the total score. The present invention was completed through further research based on this finding.

[0007] That is, the present invention provides the following aspects. Item 1. A kit for testing a cognitive function level by an olfactory test, comprising: Two or more types of fragrance liquids used in olfactory testing; A multiple choice sheet to use in answering the smell test, and A judgment sheet for judging a cognitive function level, The option sheet shows a plurality of options including a correct answer for each fragrance liquid used in the olfactory test, The assessment sheet shows the correct answer for each fragrance liquid used in the olfactory test, a score awarded depending on whether the answer is correct or incorrect, and an indicator of the cognitive function level depending on the total score, in this test kit. Item 2. The test kit according to Item 1, wherein the flavor liquid comprises at least two types selected from the group consisting of a butter-like flavor liquid, a toothpaste-like flavor liquid, and an India ink-like flavor liquid. Item 3. The test kit according to Item 2, further comprising at least one fragrance liquid selected from the group consisting of an apple-like fragrance liquid, a cypress-like fragrance liquid, and a soap-like fragrance liquid as the fragrance liquid. Item 4. The test kit according to any one of Items 1 to 3, wherein the flavor liquid includes a butter flavor liquid, a toothpaste flavor liquid, an ink flavor liquid, an apple flavor liquid, a cypress flavor liquid, and a soap flavor liquid. Item 5. The test kit according to any one of Items 1 to 4, wherein the option sheet shows, for each fragrance liquid, one option indicating the correct scent, one or more dummy options indicating scents that are not the correct answer, one option indicating "I don't know," and one option indicating "none of these." Item 6. A method for testing a cognitive function level using the test kit according to any one of items 1 to 5, A step of having a subject smell the fragrance of each of the fragrance liquids and answering the fragrance he or she felt from the options shown on the option sheet; and A testing method comprising a step of checking the subject's answers against the judgment sheet. Effect of the Invention

[0008] According to the test kit and test method of the present invention, the cognitive function level can be easily tested by a non-invasive olfactory test, making it possible to efficiently screen individuals who are at risk of developing dementia or who already have dementia. [Brief description of the drawings]

[0009] [Figure 1] FIG. 13 is a diagram showing an example of an option sheet used in the present invention. [Diagram 2] FIG. 1 is a diagram showing an example of a judgment sheet used in the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] 1. Cognitive function level test kit The test kit of the present invention is a kit for testing a cognitive function level by an olfactory test, and includes two or more types of fragrance liquids used in the olfactory test, an option sheet used for answering the olfactory test, and a judgment sheet for judging the cognitive function level, the option sheet showing a plurality of options including a correct answer for each fragrance liquid used in the olfactory test, and the judgment sheet showing the correct answer and a score for each fragrance liquid used in the olfactory test, and showing the cognitive function level judged according to the total score. The test kit of the present invention will be described in detail below.

[0011] [Fragrance liquid for olfactory testing] The test kit of the present invention includes two or more types of fragrance liquids used in an olfactory test for examining the level of cognitive function.

[0012] It is preferable that the fragrance liquid has an aroma that makes it easy to evaluate the level of cognitive function, and examples include butter-like fragrance liquid, toothpaste-like fragrance liquid, ink-like fragrance liquid, apple-like fragrance liquid, hinoki cypress fragrance liquid, soap-like fragrance liquid, vanilla ice cream-like fragrance liquid, sweaty socks-like fragrance liquid, mandarin orange-like fragrance liquid, and coffee-like fragrance liquid.

[0013] The butter-like flavor liquid is a flavor liquid that exhibits a scent reminiscent of butter. Those skilled in the art can prepare the butter-like flavor liquid by a known flavoring method using a known flavor component. For example, the butter-like flavor liquid can be prepared by blending a flavor component such as δ-decalactone, acetaldehyde, methylbutanone, or heptanal as a main component. The butter-like flavor liquid may be composed of only a flavor component, or may contain, in addition to the flavor component, water, a paraffin-based hydrocarbon, a monohydric lower alcohol, a polyhydric alcohol, or other solvent; a surfactant, a solubilizer, or other additive. The content of the flavor component in the butter-like flavor liquid is not particularly limited as long as it can exhibit a scent reminiscent of butter, and may be, for example, 0.001 to 100% by weight. From the viewpoint of further improving the accuracy of the test of the cognitive function level, the content of the flavor component in the butter-like flavor liquid is preferably 0.001 to 10% by weight, more preferably 0.005 to 1.0% by weight.

[0014] A toothpaste flavoring liquid is a flavoring liquid that exhibits an aroma reminiscent of toothpaste. A person skilled in the art can prepare a toothpaste flavoring liquid by a known flavoring method using a known flavoring component. For example, a toothpaste flavoring liquid can be prepared by blending flavoring components such as carvone, mint oil, menthofuran, menthol, menthone, menthyl acetate, pulegone, and lotundiholone as main components. A toothpaste flavoring liquid may be composed of only a flavoring component, or may contain, in addition to the flavoring component, water, a paraffin-based hydrocarbon, a monohydric lower alcohol, a polyhydric alcohol, and other solvents; a surfactant, a solubilizer, and other additives. The content of the flavoring component in the toothpaste flavoring liquid is not particularly limited as long as it can exhibit an aroma reminiscent of toothpaste, and may be, for example, 0.001 to 100% by weight. From the viewpoint of further improving the accuracy of the test of the cognitive function level, the content of the flavor component in the toothpaste flavor liquid is preferably 0.001 to 10% by weight, and more preferably 0.005 to 5.0% by weight.

[0015] The ink-mixed fragrance liquid is a fragrance liquid that exhibits a scent reminiscent of ink. Those skilled in the art can prepare the ink-mixed fragrance liquid by a known fragrance blending method using known fragrance components. For example, the ink-mixed fragrance liquid can be prepared by blending a fragrance component such as borneol as a main component. The ink-mixed fragrance liquid may be composed of only fragrance components, or may contain water, paraffin-based hydrocarbons, monohydric lower alcohols, polyhydric alcohols, and other solvents; surfactants, solubilizers, and other additives in addition to the fragrance components. The content of the fragrance components in the ink-mixed fragrance liquid is not particularly limited as long as it can exhibit a scent reminiscent of ink, and may be, for example, 0.0005 to 100% by weight. From the viewpoint of further improving the accuracy of the test of the cognitive function level, the content of the fragrance components in the ink-mixed fragrance liquid is preferably 0.001 to 10% by weight, more preferably 0.001 to 1% by weight.

[0016] The apple-like fragrance liquid is a fragrance liquid that has a scent reminiscent of apples. Those skilled in the art can prepare the apple-like fragrance liquid by a known fragrance blending method using known fragrance ingredients. For example, the apple-like fragrance liquid can be prepared by blending one or more fragrance ingredients selected from 2-(tert-butyl)cyclohexyl acetate, allyl heptanoate, ethylene brassylate, hexyl acetate, hexanol, hexanal, trans-2-hexenal, ethyl butyrate, butyl acetate, butyl butyrate, etc., as the main ingredient. The apple-like fragrance liquid may be composed of only fragrance ingredients, or may contain, in addition to the fragrance ingredients, water, paraffin-based hydrocarbons, monohydric lower alcohols, polyhydric alcohols, and other solvents; surfactants, solubilizers, and other additives. The content of the flavor component in the apple flavor liquid is not particularly limited as long as it can exhibit a scent reminiscent of apples, and may be, for example, 0.001 to 100% by weight. From the viewpoint of further improving the accuracy of the test of cognitive function level, the content of the flavor component in the apple flavor liquid is preferably 0.01 to 50% by weight, more preferably 0.02 to 10% by weight.

[0017] The hinoki-style fragrance liquid is a fragrance liquid that exhibits a scent reminiscent of hinoki. Those skilled in the art can prepare the hinoki-style fragrance liquid by a known fragrance blending method using known fragrance ingredients. For example, the hinoki-style fragrance liquid can be prepared by blending one or more fragrance ingredients selected from α-cedrene, cedrol, thujopsene, hinokitiol, α-pinene, etc. as the main ingredient. The hinoki-style fragrance liquid may be composed of only fragrance ingredients, or may contain, in addition to the fragrance ingredients, water, paraffin-based hydrocarbons, monohydric lower alcohols, polyhydric alcohols, and other solvents; surfactants, solubilizers, and other additives. The content of the fragrance ingredients in the hinoki-style fragrance liquid is not particularly limited as long as it can exhibit a scent reminiscent of hinoki, and may be, for example, 0.001 to 100% by weight. From the viewpoint of further improving the accuracy of the test of the cognitive function level, the content of the fragrance component in the hinoki-like fragrance liquid is preferably 0.005 to 50% by weight, and more preferably 0.005 to 10% by weight.

[0018] A soap-flavored liquid is a fragrance liquid that has a scent reminiscent of soap. Those skilled in the art can prepare a soap-flavored liquid by a known fragrance blending method using known fragrance components. For example, a soap-flavored liquid can be prepared by blending one or more fragrance components selected from methyl dihydrojasmonate, phenyl alcohol, 2-phenylethanol, geraniol, nerol, citronellol, aldehyde, etc., as the main component. The soap-flavored liquid may be composed of only fragrance components, or may contain, in addition to the fragrance components, water, paraffin-based hydrocarbons, monohydric lower alcohols, polyhydric alcohols, and other solvents; surfactants, solubilizers, and other additives. The content of the fragrance components in the soap-flavored liquid is not particularly limited as long as it can present a scent reminiscent of soap, and may be, for example, 0.001 to 100% by weight. From the viewpoint of further improving the accuracy of the test of the cognitive function level, the content of the fragrance component in the soap-like fragrance liquid is preferably 0.001 to 10% by weight, and more preferably 0.002 to 1.0% by weight.

[0019] The vanilla ice cream flavoring liquid is a flavoring liquid that exhibits a scent reminiscent of vanilla ice cream. A person skilled in the art can prepare the vanilla ice cream flavoring liquid by a known flavoring method using a known flavoring component. For example, the vanilla ice cream flavoring liquid can be prepared by blending a flavoring component such as vanillin as a main component. The vanilla ice cream flavoring liquid may be composed of only a flavoring component, or may contain, in addition to the flavoring component, water, a paraffin-based hydrocarbon, a monohydric lower alcohol, a polyhydric alcohol, or other solvent; a surfactant, a solubilizer, or other additive. The content of the flavoring component in the vanilla ice cream flavoring liquid is not particularly limited as long as it can exhibit a scent reminiscent of vanilla ice cream, and may be, for example, 0.001 to 100% by weight, preferably 0.002 to 10% by weight, and more preferably 0.02 to 10% by weight.

[0020] The sweaty socks fragrance liquid is a fragrance liquid that gives off a scent reminiscent of sweaty socks. Those skilled in the art can prepare the sweaty socks fragrance liquid by using known fragrance ingredients and known fragrance blending methods. For example, the sweaty socks fragrance liquid can be prepared by blending a fragrance ingredient such as isovaleric acid as the main ingredient. The sweaty socks fragrance liquid may be composed of only fragrance ingredients, or may contain water, paraffinic hydrocarbons, monohydric lower alcohols, polyhydric alcohols, and other solvents; surfactants, solubilizers, and other additives in addition to the fragrance ingredients. The content of the fragrance ingredients in the sweaty socks fragrance liquid is not particularly limited as long as it can give off a scent reminiscent of sweaty socks, and may be, for example, 0.001 to 100% by weight, preferably 0.005 to 25% by weight, and more preferably 0.05 to 5.0% by weight.

[0021] The mandarin orange flavor liquid is a flavor liquid that exhibits a scent reminiscent of mandarin oranges. Those skilled in the art can prepare the mandarin orange flavor liquid by a known flavor blending method using known flavor ingredients. For example, the mandarin orange flavor liquid can be prepared by blending flavor ingredients such as D-limonene, myrcene, α-pinene, linalool, etc. as the main ingredient. The mandarin orange flavor liquid may be composed of only the flavor ingredients, or may contain water, paraffin-based hydrocarbons, monohydric lower alcohols, polyhydric alcohols, and other solvents; surfactants, solubilizers, and other additives in addition to the flavor ingredients. The content of the flavor ingredients in the mandarin orange flavor liquid is not particularly limited as long as it can exhibit a scent reminiscent of mandarin oranges, and may be, for example, 0.001 to 100% by weight, preferably 0.05 to 50% by weight, and more preferably 0.1 to 10.0% by weight.

[0022] The coffee flavor liquid is a flavor liquid that exhibits an aroma reminiscent of coffee. Those skilled in the art can prepare the coffee flavor liquid by a known flavor blending method using known flavor components. For example, the coffee flavor liquid can be prepared by blending flavor components such as methylcyclopentenolone, furfural, vanillin, and furfuryl mercaptan as main components. The coffee flavor liquid may be composed of only the flavor components, or may contain, in addition to the flavor components, water, paraffin-based hydrocarbons, monohydric lower alcohols, polyhydric alcohols, and other solvents; surfactants, solubilizers, and other additives. The content of the flavor components in the coffee flavor liquid is not particularly limited as long as it can exhibit an aroma reminiscent of mandarin oranges, and may be, for example, 0.00 to 100% by weight, preferably 0.002 to 10% by weight, and more preferably 0.0025 to 5.0% by weight.

[0023] In the test kit of the present invention, it is sufficient that two or more types of fragrance liquids are contained, but from the viewpoint of further improving the accuracy of the test of cognitive function level, preferably three or more types, more preferably 3 to 10 types, even more preferably 4 to 8 types, and particularly preferably 5 to 7 types.

[0024] In addition, the combination of flavor liquids used in the test kit of the present invention is not particularly limited, but from the viewpoint of further improving the test accuracy of the cognitive function level, it is preferable that two or more types of butter-like flavor liquid, toothpaste-like flavor liquid, and ink-like flavor liquid are included in combination, preferably three types of these are included in combination. Furthermore, from the viewpoint of further improving the test accuracy of the cognitive function level, the combination of flavor liquids used in the test kit of the present invention is preferably a combination of two or more types of butter-like flavor liquid, toothpaste-like flavor liquid, and ink-like flavor liquid with at least one type of apple-like flavor liquid, cypress-like flavor liquid, and soap-like flavor liquid; more preferably, the combination of three types of butter-like flavor liquid, toothpaste-like flavor liquid, and ink-like flavor liquid with apple-like flavor liquid. More preferably, the combination of three types of fragrance liquid, namely, butter-scented fragrance liquid, toothpaste-scented fragrance liquid, and ink-scented fragrance liquid, with two or more types of fragrance liquid, namely, apple-scented fragrance liquid, cypress-scented fragrance liquid, and soap-scented fragrance liquid; particularly preferably, the combination of six types of fragrance liquid, namely, butter-scented fragrance liquid, toothpaste-scented fragrance liquid, ink-scented fragrance liquid, apple-scented fragrance liquid, cypress-scented fragrance liquid, and soap-scented fragrance liquid.

[0025] In one embodiment of the test kit of the present invention, the flavor liquid is provided in a spray container (such as a spray container), a drop container, or an application container (such as a pen-shaped container). When the flavor liquid is provided in such a container, the flavor liquid contained in the container may be sprayed, dropped, or applied to the base material to be scented, and an olfactory test may be performed. That is, in the test kit of the present invention, when the flavor liquid is contained in a spray container, a drop container, or an application container, the test kit of the present invention may further include a base material to be scented. In the test kit of this embodiment, the amount of flavor liquid contained in the container may be an amount used for one test, or may be an amount used for two or more tests. In the test kit of this embodiment, the amount of the fragrance liquid sprayed, dropped or applied to the fragrance substrate is not particularly limited as long as the fragrance of each fragrance liquid can be imparted to the fragrance substrate, and may be appropriately set according to the composition of the fragrance liquid used, for example, 10 to 1000 μl, preferably 50 to 500 μl, and more preferably 100 to 400 μl. The material of the fragrance substrate is not particularly limited as long as it can be scented with the fragrance liquid, and examples of the material include paper, nonwoven fabric, woven fabric, knitted fabric, plastic, etc. The shape of the fragrance substrate is also not particularly limited as long as it can be used for olfactory testing, and examples of the material include sheet, cup, block, sponge, etc.

[0026] In another embodiment of the test kit of the present invention, the fragrance liquids are provided in a sealed state in a container having an openable opening. When the fragrance liquids are provided in the container in a sealed state, the olfactory test may be performed by opening the container and smelling the fragrance emitted from the opening. In the test kit of this embodiment, the amount of the fragrance liquids contained in the container is not particularly limited as long as the fragrance of each fragrance liquid is exhibited when the opening is opened, and may be, for example, 10 to 1000 μl, preferably 50 to 500 μl, and more preferably 100 to 400 μl.

[0027] In yet another embodiment of the test kit of the present invention, the fragrance liquid is provided in a state where it is impregnated into a substrate such as paper, nonwoven fabric, woven fabric, knitted fabric, filter paper, sponge, gel, etc. and sealed. When the fragrance liquid is provided in a state where it is impregnated into the substrate, the substrate impregnated with the fragrance liquid may be removed and the odor may be smelled to perform an olfactory test. In the test kit of this embodiment, the amount of the fragrance liquid impregnated into the substrate is not particularly limited as long as the odor of each fragrance liquid is exhibited, and may be, for example, 10 to 1000 μl, preferably 50 to 500 μl, more preferably 100 to 400 μl per substrate.

[0028] In the test kit of the present invention, it is preferable that the containers for the flavor liquids are assigned a code for each flavor liquid so that two or more flavor liquids are not mixed up.

[0029] [Choice sheet] The test kit of the present invention includes a choice sheet that is used by the subject to answer the olfactory test.

[0030] The choice sheet shows a plurality of choices including a correct answer for each fragrance liquid. The choice sheet preferably shows one choice indicating the correct fragrance, one or more dummy choices indicating fragrances that are not the correct answer, one choice indicating "I don't know," and one choice indicating "not included in these." The choice sheet may show one or more dummy choices, but in order to test the cognitive function level with higher accuracy, it is preferable to show two or more, and more preferably two to four. The type of fragrance shown in the dummy choice may be set to a fragrance that easily distinguishes between correct and incorrect depending on the level of cognitive function, taking into consideration the type of fragrance that is the correct answer.

[0031] For example, one example of a multiple-choice sheet to be used when answering an olfactory test using a butter-flavoring liquid is a multiple-choice sheet showing a total of six options: "butter" (correct answer option), "urine odor" (dummy option), "cinnamon" (dummy option), "apple" (dummy option), "I don't know," and "none of these."

[0032] For example, one example of a choice sheet to be used when answering an olfactory test using toothpaste flavoring liquid is a choice sheet showing a total of six options: "Toothpaste" (correct answer option), "Sewer" (dummy option), "Wasabi" (dummy option), "Rubber" (dummy option), "I don't know," and "None of these."

[0033] For example, in the case of ink fragrance liquid, a choice sheet may be presented showing a total of six options: "ink" (correct answer), "miso" (dummy option), "curry" (dummy option), "sweat odor" (dummy option), "I don't know," and "It's not one of these."

[0034] For example, one example of a choice sheet to be used when answering an olfactory test using apple flavoring liquid is a choice sheet showing a total of six options: "apple" (correct answer option), "hinoki" (dummy option), "soil" (dummy option), "garlic" (dummy option), "I don't know," and "none of these."

[0035] For example, one example of a choice sheet to be used when answering an olfactory test using hinoki fragrance liquid is a choice sheet showing a total of six options: "hinoki" (correct answer option), "curry" (dummy option), "coffee" (dummy option), "garlic" (dummy option), "I don't know," and "none of these."

[0036] For example, one example of a choice sheet to be used when answering an olfactory test using a soap-like fragrance liquid is a choice sheet showing a total of six options: "soap" (correct answer option), "food waste" (dummy option), "garlic" (dummy option), "glue" (dummy option), "I don't know," and "none of these."

[0037] For example, one example of a choice sheet to be used when answering an olfactory test using vanilla ice cream flavoring liquid is a choice sheet showing a total of six options: "vanilla ice cream" (correct answer option), "peppermint" (dummy option), "garlic" (dummy option), "sweat odor" (dummy option), "I don't know," and "none of these."

[0038] For example, one example of a multiple-choice sheet to be used when answering an olfactory test using a sweaty sock fragrance liquid is a multiple-choice sheet showing a total of six options: "sweaty socks" (correct answer option), "tatami mat" (dummy option), "soy sauce" (dummy option), "rose" (dummy option), "I don't know," and "none of these."

[0039] For example, one example of a choice sheet to be used when answering an olfactory test using a mandarin orange fragrance liquid is a choice sheet showing a total of six options: "mandarin orange" (correct answer option), "incense" (dummy option), "household gas" (dummy option), "curry" (dummy option), "I don't know," and "none of these."

[0040] For example, one example of a choice sheet to be used when answering an olfactory test using a coffee flavoring liquid is a choice sheet showing a total of six options: "coffee" (correct answer option), "incense" (dummy option), "food waste" (dummy option), "rubber" (dummy option), "I don't know," and "none of these."

[0041] It is desirable to code the option sheet for each fragrance liquid used in the olfactory test so that the subject does not confuse the option groups from which to select answers during the olfactory test.

[0042] For example, in the case where a hinoki-style fragrance liquid, a soap-style fragrance liquid, a butter-style fragrance liquid, an apple-style fragrance liquid, an ink-style fragrance liquid, and a toothpaste-style fragrance liquid are used as the fragrance liquids in the test kit of the present invention, an example of the option sheet is shown in Figure 1. In the option sheet shown in Figure 1, the scent "A" column shows the option to be used when using a hinoki-style fragrance liquid, the scent "B" column shows the option to be used when using a soap-style fragrance liquid, the scent "C" column shows the option to be used when using a butter-style fragrance liquid, the scent "D" column shows the option to be used when using an apple-style fragrance liquid, the scent "E" column shows the option to be used when using an ink-style fragrance liquid, and the scent "F" column shows the option to be used when using a toothpaste-style fragrance liquid.

[0043] [Judgment sheet] The test kit of the present invention includes a judgment sheet for judging the cognitive function level. By using the judgment sheet, the result of the olfactory test of the subject is scored, and the cognitive function level can be easily judged.

[0044] The assessment sheet shows the correct answer for each fragrance liquid used in the olfactory test and a score to be given depending on whether the answer is correct or incorrect. The score to be given depending on whether the answer is correct or incorrect may be appropriately set for each fragrance liquid used so that the cognitive function level can be easily identified.

[0045] For example, in the case of using a butter-flavored liquid, a toothpaste-flavored liquid, an ink-flavored liquid, and other flavored liquids as necessary, the scores to be awarded according to the correctness or incorrectness of the olfactory test answers for each flavored liquid may be set so as to satisfy the ratios shown in Table 1 (hereinafter, sometimes referred to as "score gradient pattern A").

[0046] [Table 1]

[0047] For example, in the case of using a combination of three fragrance liquids, i.e., an apple-like fragrance liquid, a cypress-like fragrance liquid, and a soap-like fragrance liquid, as the other fragrance liquids in the score gradient pattern A, the scores to be awarded according to the correctness or incorrectness of the olfactory test answers for each fragrance liquid can be set to satisfy the ratio shown in Table 2 (hereinafter sometimes referred to as "score gradient pattern A'").

[0048] [Table 2]

[0049] As another suitable example, when using a butter-like flavoring liquid, a toothpaste-like flavoring liquid, an ink-like flavoring liquid, and other flavoring liquids as necessary, the score to be awarded depending on whether the answer to the olfactory test for each flavoring liquid is correct or incorrect may be set to satisfy the ratio shown in Table 3 (hereinafter, sometimes referred to as "score gradient pattern B"). [Table 3]

[0050] For example, in the case of using a combination of three other fragrance liquids, i.e., an apple-like fragrance liquid, a cypress-like fragrance liquid, and a soap-like fragrance liquid, in the score gradient pattern B, the scores to be awarded according to the correctness or incorrectness of the olfactory test answers for each fragrance liquid can be set to satisfy the ratio shown in Table 4 (hereinafter sometimes referred to as "score gradient pattern B'"). [Table 4]

[0051] The assessment sheet also shows an index of the cognitive function level according to the total score calculated from the scores given for each fragrance liquid used in the olfactory test according to whether the answer is correct or incorrect. For example, by setting an index of the cognitive function level according to the total score based on the cutoff value of the total score of those with a good cognitive function level and those whose cognitive function level is on a downward trend, and the cutoff value of the total score of those whose cognitive function level is on a downward trend and those whose cognitive function level is of concern, it is possible to show an index of whether the cognitive function level corresponds to "good", "on a downward trend", or "with concern".

[0052] The total score of the olfactory test result may vary even for the same subject depending on the combination of the fragrance liquids used in the test kit of the present invention, the fragrance intensity of the fragrance liquid, the olfactory test method, etc., so in order to further improve the test accuracy of the cognitive function level, it is sufficient to determine an index of the cognitive function level according to the total score using the test kit actually used. For example, an olfactory test is performed in advance on a plurality of people with good cognitive function levels (e.g., healthy people confirmed not to have mild cognitive impairment), a plurality of people with a tendency for cognitive function levels to decline (e.g., people diagnosed with mild cognitive impairment), and a plurality of people with concerns about their cognitive function levels (e.g., people diagnosed with dementia), and the total scores of each are obtained, and the cutoff values ​​of the total score of those with good cognitive function levels and those with a tendency for cognitive function levels to decline, and the cutoff values ​​of the total score of those with a tendency for cognitive function levels to decline and those with a clearly declining cognitive function level are obtained, and based on these cutoff values, an index of whether the cognitive function level corresponds to "good", "tending to decline", or "concern" according to the total score can be displayed. The cutoff value can be determined by ROC (receiver operating characteristic curve) analysis of the total score.

[0053] For example, when the option sheet shown in FIG. 1 is used, an example of the judgment sheet is shown in FIG. 2. In the option sheet shown in FIG. 2, the options shown in the option sheet for each fragrance liquid (red to red) are listed in the "score table" column, and the correct answer option is assigned a score (number). In the option sheet shown in FIG. 2, the score assigned to the correct answer option is assigned in the case of a correct answer, and the score assigned in the case of an incorrect answer is 0. In the option sheet shown in FIG. 2, the "score table" column also has a column for entering a total score. In addition, in the option sheet shown in FIG. 2, the "index of cognitive function level" column shows an index of cognitive function level according to the total score, and an index is shown that a total score of 9 to 10 points indicates a good cognitive function level, a total score of 5 to 8 points indicates a tendency for the cognitive function level to decline, and a total score of 4 points or less indicates concerns about the cognitive function level.

[0054] In the test kit of the present invention, the choice sheet and the determination sheet may be provided together on a single sheet, and may be configured so that they can be separated when used.

[0055] [How to use the test kit] To test the cognitive function level using the test kit of the present invention, first, the subject smells each fragrance liquid and answers the fragrance that he / she senses from the options shown on the option sheet. The subject may smell two or more fragrance liquids consecutively, but in order to prevent olfactory habituation, a break of several minutes may be taken between each fragrance liquid, or several fragrance liquids may be consecutively smelled after a break of several minutes.

[0056] Next, the subject's answers are checked against the assessment sheet to calculate a total score (the sum of the scores given for each fragrance liquid) according to whether the subject's answers are correct or incorrect, and the subject's cognitive function level is determined based on the total score. The subject himself may check the answers against the assessment sheet, or someone other than the subject may check the answers against the assessment sheet.

[0057] 2. How to test cognitive function level The test method of the present invention is a method for testing a cognitive function level using the kit, and is characterized by including a step of having a subject smell the fragrance of each fragrance liquid and answering the scent that he or she senses from among the options shown on a choice sheet, and a step of checking the subject's answers against the assessment sheet. The embodiments of the test method of the present invention are as shown in the above section "Cognitive Function Level Test Kit".

[0058] 3. Study of suitable flavoring liquid and score for cognitive function level test The following shows the results of examining fragrance liquids and scores that can test cognitive function levels with high accuracy. However, the present invention should not be construed as being limited to the results shown below.

[0059] Test Example ·subject The subjects were 100 healthy subjects, 61 subjects with mild cognitive impairment (MCI), and 62 subjects with Alzheimer's disease (AD).

[0060] The 100 healthy subjects were those with a Mini-mental State Examination (MMSE) score of 28 or higher.

[0061] The 61 MCI patients had an MMSE score of 24 to 27 and were diagnosed with mild cognitive impairment with memory impairment by a dementia specialist based on the diagnostic criteria of Petersen et al. (Petersen RC: Mild cognitive impairment as a diagnostic entity. J. Intern. Med. 2004; 256(3): 183-194.).

[0062] The 62 AD patients had an MMSE score of 23 or less and were diagnosed with Alzheimer's disease by a dementia specialist based on either the International Classification of Diseases-10 (ICD-10), the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5), or the National Institute on Aging and Alzheimer's Association (NIA-AA).

[0063] Preparation of fragrance liquid Fragrance liquids (total of 20 kinds, 10 types of fragrance) with various fragrances of the composition shown below were prepared. Note that fragrance liquid B contains 10 to 454 times the amount of fragrance compared to fragrance liquid A containing the same fragrance. Butter-like flavoring liquid A: A flavoring liquid containing 0.01% by weight of a butter-like flavoring component (containing δ-decalactone) and exhibiting a buttery scent. Butter-like flavoring liquid B: A flavoring liquid containing 0.5% by weight of a butter-like flavoring component (containing δ-decalactone) and exhibiting a buttery scent. Toothpaste flavoring liquid A: A flavoring liquid that contains 0.01% by weight of toothpaste flavoring ingredients (including carvone) and has a toothpaste scent. Toothpaste-like fragrance liquid B: A fragrance liquid containing 2.5% by weight of toothpaste-like fragrance ingredients (containing carvone) that gives off the scent of toothpaste. Ink-like fragrance liquid A: A fragrance liquid that contains 0.001% by weight of an ink-like fragrance component (containing borneol) and has the scent of ink. Ink-like fragrance liquid B: A fragrance liquid that contains 0.1% by weight of an ink-like fragrance component (containing borneol) and has the scent of ink. Apple-like fragrance liquid A: A fragrance liquid containing 0.04% by weight of apple-like fragrance ingredients (containing 2-(tert-butyl)cyclohexyl acetate, allyl heptanoate, ethylene brassylate, and hexyl acetate) and exhibiting an apple scent. Apple-like fragrance liquid B: A fragrance liquid containing 5.0% by weight of apple-like fragrance ingredients (containing 2-(tert-butyl)cyclohexyl acetate, allyl heptanoate, ethylene brassylate, and hexyl acetate) and exhibiting an apple scent. Soap-like fragrance liquid A: A fragrance liquid containing 0.00% by weight of soap-like fragrance ingredients (including methyl dihydrojasmonate and phenyl alcohol) and having a soapy scent. Soap-like fragrance liquid B: A fragrance liquid containing 0.12% by weight of soap-like fragrance ingredients (including methyl dihydrojasmonate and phenyl alcohol) that gives off a soapy scent. Hinoki-like fragrance liquid A: A fragrance liquid that contains 0.011% by weight of hinoki-like fragrance ingredients (including α-cedrene, cedrol, and thujopsene) and has a hinoki scent. Hinoki-like fragrance liquid B: A fragrance liquid containing 5.0% by weight of hinoki-like fragrance ingredients (including α-cedrene, cedrol and thujopsene) that gives off a hinoki scent. Vanilla ice cream flavoring liquid A: A flavoring liquid containing 0.02% by weight of vanilla ice cream flavoring ingredients (including vanillin) and exhibiting the scent of vanilla ice cream. Vanilla ice cream flavoring liquid B: A flavoring liquid containing 5.0% by weight of vanilla ice cream flavoring ingredients (including vanillin) and exhibiting the scent of vanilla ice cream. Sweaty socks fragrance liquid A: A fragrance liquid that contains 0.1% by weight of sweaty socks fragrance ingredients (containing isovaleric acid) and gives off the scent of sweaty socks. Sweaty socks fragrance liquid B: A fragrance liquid containing 2.5% by weight of sweaty socks fragrance ingredients (containing isovaleric acid) that gives off the scent of sweaty socks. Orange-like fragrance liquid A: A fragrance liquid containing 0.5% by weight of orange-like fragrance ingredients (containing limonene) that gives off an orange scent. Orange fragrance liquid B: Contains 5.0% by weight of orange fragrance (containing limonene) and has an orange scent. Coffee-like flavor liquid A: A flavor liquid containing 0.0025% by weight of a coffee-like flavor component (containing methylcyclopentenolone) and exhibiting a coffee aroma. Coffee-like flavor liquid B: A flavor liquid containing 1.0% by weight of a coffee-like flavor component (containing methylcyclopentenolone) and exhibiting a coffee aroma.

[0064] ·Olfaction test First, the fragrance liquid was sprayed twice into a 95 ml paper cup with a sprayer to attach about 300 μl of the fragrance liquid to the paper cup, thereby preparing a fragrance paper cup. A fragrance paper cup was prepared for each of the 20 fragrance liquids.

[0065] Five test order patterns P to T shown in Table 5 were prepared, and the test order patterns were set randomly for the subjects. According to the set test order pattern, scented paper cups (paper cups with fragrance liquid A attached) of test order No. 1 to No. 10 were arranged on the table, and the subjects were made to smell the scents in the order of test order No. 1 to No. 5 and answer questions. After that, a two-minute break was taken to prevent olfactory habituation, and then the subjects were made to smell the scents in the order of test order No. 6 to No. 10 and answer questions. After that, a five-minute break was taken to prevent olfactory habituation. Next, according to the set test order pattern, scented paper cups (paper cups with fragrance liquid B attached) of test order No. 11 to No. 20 were arranged on the table, and the subjects were made to smell the scents in the order of test order No. 11 to No. 15 and answer questions. After that, a two-minute break was taken to prevent olfactory habituation, and then the subjects were made to smell the scents in the order of test order No. 16 to No. 20 and answer questions.

[0066] Each time the subjects smelled the scented paper cup, they were asked to answer whether or not they sensed a certain scent. If they answered that they sensed a certain scent, they were shown options A to F set for each fragrance liquid shown in Table 6, and asked to answer which of A to F the scent they sensed corresponded to.

[0067] [Table 5]

[0068] [Table 6]

[0069] ·result Table 7 shows the average percentage of subjects who correctly answered the scent (correct answer rate) in the test of 20 types of fragrance liquids for healthy subjects, MCI subjects, and AD subjects. When comparing fragrance liquids containing the same fragrance, fragrance liquid A, which has a low fragrance concentration, with fragrance liquid B, which has a high fragrance concentration, there was a tendency for fragrance liquid B to have a higher correct answer rate. However, in terms of the difference in correct answer rate between MCI and healthy subjects, and between MCI and AD, the same tendency was observed between fragrance liquid A and fragrance liquid B. Furthermore, in the test of 20 types of fragrance liquids, the correct answer rate was highest in the order of healthy subjects, followed by MCI, and then AD.

[0070] However, the difference in the correct answer rate between MCI and healthy subjects was larger for toothpaste-like flavoring liquid, butter-like flavoring liquid, and ink-like flavoring liquid than for other flavoring liquids. In addition, the difference in the correct answer rate between MCI and AD was large for toothpaste-like flavoring liquid, butter-like flavoring liquid, and ink-like flavoring liquid, and the difference in the correct answer rate between MCI and AD was particularly remarkable for ink-like flavoring liquid. Furthermore, the difference in the correct answer rate between MCI and MCI was relatively large for apple-like flavoring liquid, cypress-like flavoring liquid, and soap-like flavoring liquid, and the difference in the correct answer rate between MCI and MCI was also large. From the above results, it was revealed that by performing an olfactory test using toothpaste, butter-like flavoring liquid, and ink-like flavoring liquid, the discrimination between MCI and healthy subjects and between MCI and AD were high, and MCI could be tested with high accuracy. It was also revealed that MCI can be tested with higher accuracy by performing an olfactory test using an apple-like fragrance liquid, a cypress-like fragrance liquid, and a soap-like fragrance liquid in addition to the above-mentioned fragrance liquid.

[0071] [Table 7]

[0072] Next, ROC analysis was performed to examine the test accuracy when multiple flavoring liquids were combined. Specifically, based on the results of 10 types of flavoring liquid B with high flavoring concentrations, a correct answer for one flavoring liquid B was scored as 1 point, and ROC analysis was performed using the total score when each flavoring liquid was combined as shown in Tables 8 and 9, and the AUC (Area Under the Curve), cutoff value, sensitivity, and specificity of the ROC curve were obtained. SAS (release 9.4) (SAS Institute Japan Co., Ltd.) was used for the ROC analysis, and the cutoff value was calculated by the Youden Index method. The results are shown in Tables 8 and 9. When the test results of the flavoring liquids exhibiting the scents of toothpaste, butter, and ink were combined, the AUC and sensitivity in the ROC analysis were high between MCI and healthy subjects, and between MCI and AD, and the specificity was low, and it was found that it was possible to distinguish between MCI and healthy subjects, and between MCI and AD, and that a highly accurate test for MCI was possible. In particular, it was confirmed that the accuracy of the MCI test could be further improved by performing an olfactory test using at least one of the toothpaste-like flavoring liquid, butter-like flavoring liquid, and India ink-like flavoring liquid, and particularly a combination of these four types of flavoring liquid.

[0073] [Table 8]

[0074] [Table 9]

[0075] As described above, by performing ROC analysis with a score of 1 point for each correct answer for one flavor liquid, it was confirmed that the olfactory test using toothpaste flavor liquid, butter flavor liquid, India ink flavor liquid, apple flavor liquid, cypress flavor liquid, and soap flavor liquid is particularly effective for highly accurate MCI testing. Next, the score for a correct answer for each flavor liquid was changed to that shown in Table 10, and the test accuracy when the six flavor liquids were combined was examined by ROC analysis. The results are shown in Table 11. As a result, it was found that the test accuracy of MCI was further improved when the score for a correct answer for each flavor liquid was scored, as in the score gradient patterns A' and B'. In particular, it was confirmed that the test accuracy of MCI was significantly improved by scoring according to the score gradient pattern A'.

[0076] [Table 10]

[0077] [Table 11]

Claims

1. A kit for testing a cognitive function level by an olfactory test, comprising: Two or more kinds of fragrance liquids used in olfactory testing; A multiple choice sheet to use in answering the smell test, and A judgment sheet for judging a cognitive function level, The option sheet shows a plurality of options including a correct answer for each fragrance liquid used in the olfactory test, The assessment sheet shows the correct answer for each fragrance liquid used in the olfactory test and a score awarded depending on whether the answer is correct or incorrect, and also shows an indicator of the cognitive function level depending on the total score.

2. 2. The test kit according to claim 1, wherein the flavor liquid comprises at least two types selected from the group consisting of a butter-like flavor liquid, a toothpaste-like flavor liquid, and an India ink-like flavor liquid.

3. The test kit according to claim 2 , further comprising at least one fragrance liquid selected from the group consisting of an apple-like fragrance liquid, a cypress-like fragrance liquid, and a soap-like fragrance liquid as the fragrance liquid.

4. The test kit according to any one of claims 1 to 3, wherein the fragrance liquid includes a butter-like fragrance liquid, a toothpaste-like fragrance liquid, an ink-like fragrance liquid, an apple-like fragrance liquid, a cypress-like fragrance liquid, and a soap-like fragrance liquid.

5. The test kit according to any one of claims 1 to 4, wherein the option sheet shows, for each fragrance liquid, one option indicating the correct scent, one or more dummy options for scents that are not the correct answer, one option for "I don't know," and one option for "none of these."

6. A method for testing a cognitive function level using the test kit according to any one of claims 1 to 5, A step of having a subject smell the fragrance of each of the fragrance liquids and answering the fragrance he or she felt from the options shown on the option sheet; and A testing method comprising a step of checking the subject's answers against the judgment sheet.

Images