WO2018008764A1 - 軽度認知障害又はアルツハイマー型認知症の評価方法 - Google Patents
軽度認知障害又はアルツハイマー型認知症の評価方法 Download PDFInfo
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- WO2018008764A1 WO2018008764A1 PCT/JP2017/025051 JP2017025051W WO2018008764A1 WO 2018008764 A1 WO2018008764 A1 WO 2018008764A1 JP 2017025051 W JP2017025051 W JP 2017025051W WO 2018008764 A1 WO2018008764 A1 WO 2018008764A1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
- G01N33/6896—Neurological disorders, e.g. Alzheimer's disease
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/28—Neurological disorders
- G01N2800/2814—Dementia; Cognitive disorders
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/28—Neurological disorders
- G01N2800/2814—Dementia; Cognitive disorders
- G01N2800/2821—Alzheimer
Definitions
- MCI Mil Cognitive Impairment
- AD Alzheimer's disease
- the present invention relates to an evaluation method, an evaluation device, an evaluation program, an evaluation system, and a terminal device.
- Dementia refers to a state in which intellectual functions normally developed due to acquired brain lesions are generally and continuously reduced, resulting in problems in daily life. “Normally caused by chronic or progressive brain disease. It is a disease defined as "a syndrome consisting of many disorders of higher cerebral function such as memory, thinking, orientation, understanding, calculation, learning, language, judgment, etc.” (Non-patent Document 1). Alzheimer-type dementia accounts for the highest proportion of causative diseases of dementia consisting of about 60%.
- Typical neuropathological features of AD include senile plaques and neurofibrillary tangles in the brain. It is known that the cause of senile plaques is the deposition of a protein called amyloid ⁇ (A ⁇ ), and the cause of neurofibrillary tangles is an overphosphorylated tau protein. Large-scale observational studies conducted in recent years have revealed that these pathological features have begun before the onset of AD (Non-Patent Document 2). In recent years, positron emission tomography (PET) and single photon tomography (SPECT (signone photon emission computed) have been used to quantify the accumulation of A ⁇ and phosphorylated tau protein in brain tissue and brain tissue atrophy.
- PET positron emission tomography
- SPECT single photon tomography
- Non-patent Document 3 Non-patent Document 3
- acetylcholinesterase inhibitors and NMDA (N-methyl-D-aspartic acid) receptor inhibitors are used as therapeutic agents for AD.
- these drugs only have the effect of delaying the progression of symptoms for a certain period. Therefore, the pathologic modification therapy required for the fundamental treatment has not been established yet.
- antibody drugs and the like based on neuropathological findings such as the accumulation of A ⁇ and phosphorylated tau protein have been developed, but currently no candidate drug showing a clear effect has been obtained.
- Non-Patent Documents 4 and 5 Two diagnostic criteria are mainly proposed and widely accepted. It has been shown that many patients diagnosed with MCI develop AD with high probability after several years. Therefore, by providing a simple screening method that can discriminate MCI, more subjects can visit a specialized medical institution at an earlier stage, and more patients can be treated at an earlier stage. It is expected to increase the possibility of providing it, and thus contribute to preventing the increase in the number of people with dementia.
- MMSE Minimum Mental State Examination
- HDS-R Hasegawa-style simplified intelligence evaluation scale
- ADAS-cog Alzheimer's
- Patent Document 1 a method for measuring the concentration of amino acids and amino acid-related metabolites in blood and determining the morbidity risk based on the characteristics of a specific disease is known in cancer, metabolic syndrome, liver disease, and the like.
- Patent Document 4 an AD diagnosis technique using a specific amino acid concentration in blood as an index has been devised.
- Patent Document 5 a technique for discriminating MCI by a blood test, a technique has been devised in which the peptide fragment concentration in blood is used as an index (Patent Document 5).
- the present invention has been made in view of the above, and an evaluation method, an evaluation device, an evaluation program, an evaluation system, and a terminal device that can provide highly reliable information that can be referred to when knowing the state of MCI or AD The purpose is to provide.
- the evaluation method according to the present invention comprises 23 kinds of amino acids ( ⁇ -ABA, Ala, Arg, Asn, Cit, Gln, Glu, Gly, and Gly in the blood to be evaluated.
- the method includes an evaluation step of evaluating a state of mild cognitive impairment or Alzheimer-type dementia for the evaluation object using at least one concentration value.
- the evaluation apparatus is an evaluation apparatus including a control unit, and the control unit includes at least one of the 23 types of amino acids and the 14 types of amino acid-related metabolites in the blood to be evaluated.
- An evaluation means for evaluating the state of mild cognitive impairment or Alzheimer's dementia for the evaluation object using one concentration value is provided.
- the evaluation method according to the present invention is an evaluation method executed in an information processing apparatus including a control unit, and is executed in the control unit, the 23 kinds of amino acids in the blood to be evaluated, and the 14
- the method includes an evaluation step of evaluating a state of mild cognitive impairment or Alzheimer-type dementia for the evaluation target using a concentration value of at least one of the types of amino acid-related metabolites.
- the evaluation program according to the present invention is an evaluation program for execution in an information processing apparatus including a control unit, the 23 types of amino acids in the blood to be evaluated and the 23 kinds of amino acids to be executed in the control unit.
- the method includes an evaluation step of evaluating a state of mild cognitive impairment or Alzheimer's dementia with respect to the evaluation target using a concentration value of at least one of the 14 types of amino acid-related metabolites.
- a recording medium is a non-transitory computer-readable recording medium, and includes a programmed instruction for causing an information processing apparatus to execute the evaluation method.
- the evaluation system is an evaluation system configured by connecting an evaluation device including a control unit and a terminal device including the control unit via a network so as to communicate with each other.
- the control unit includes concentration data transmitting means for transmitting concentration data regarding at least one concentration value of the 23 types of amino acids and the 14 types of amino acid-related metabolites in the blood to be evaluated to the evaluation device; And a result receiving means for receiving an evaluation result relating to the condition of mild cognitive impairment or Alzheimer's dementia for the evaluation object transmitted from the evaluation device, wherein the control unit of the evaluation device transmits from the terminal device Density data receiving means for receiving the density data, and the small amount included in the density data received by the density data receiving means.
- evaluation means for evaluating the state of mild cognitive impairment or Alzheimer-type dementia for the evaluation object, and result transmission for transmitting the evaluation result obtained by the evaluation means to the terminal device And means.
- the terminal device is a terminal device including a control unit, and the control unit includes a result acquisition unit that acquires an evaluation result related to a mild cognitive impairment or an Alzheimer-type dementia state for an evaluation target.
- the evaluation result is obtained by using a concentration value of at least one of the 23 types of amino acids and the 14 types of amino acid-related metabolites in the blood of the evaluation target, and a mild cognitive impairment or Alzheimer type for the evaluation target. It is the result of evaluating the state of dementia.
- the terminal device is connected to the evaluation device that evaluates the state of mild cognitive impairment or Alzheimer-type dementia for the evaluation target via the network in the terminal device, and the control
- the unit further includes density data transmission means for transmitting density data relating to the at least one density value to the evaluation apparatus, and the result acquisition means receives the evaluation result transmitted from the evaluation apparatus.
- the evaluation device is an evaluation device including a control unit that is communicably connected to a terminal device via a network, and the control unit is an evaluation target transmitted from the terminal device.
- Concentration data receiving means for receiving concentration data relating to the concentration value of at least one of the 23 kinds of amino acids and the 14 kinds of amino acid-related metabolites in the blood of the blood, and the concentration data received by the concentration data receiving means
- Evaluation means for evaluating the state of mild cognitive impairment or Alzheimer-type dementia for the evaluation object using the at least one concentration value contained therein, and transmitting the evaluation result obtained by the evaluation means to the terminal device And a result transmitting means.
- FIG. 1 is a principle configuration diagram showing the basic principle of the first embodiment.
- FIG. 2 is a principle configuration diagram showing the basic principle of the second embodiment.
- FIG. 3 is a diagram illustrating an example of the overall configuration of the present system.
- FIG. 4 is a block diagram showing an example of the configuration of the evaluation apparatus 100 of this system.
- FIG. 5 is a diagram showing an example of information stored in the density data file 106a.
- FIG. 6 is a diagram illustrating an example of information stored in the evaluation result file 106b.
- FIG. 7 is a block diagram illustrating a configuration of the evaluation unit 102b.
- FIG. 8 is a block diagram illustrating an example of the configuration of the client apparatus 200 of the present system.
- Embodiments of an evaluation method according to the present invention (first embodiment) and embodiments of an evaluation apparatus, an evaluation method, an evaluation program, a recording medium, an evaluation system, and a terminal device according to the present invention (second embodiment) ) Will be described in detail with reference to the drawings. Note that the present invention is not limited to these embodiments.
- FIG. 1 is a principle configuration diagram showing the basic principle of the first embodiment.
- Concentration data relating to concentration values of 23 kinds of amino acids and one or more substances arbitrarily selected from the above-mentioned 14 kinds of amino acid-related metabolites is acquired (step S11).
- step S11 density data measured by a company or the like that performs density value measurement may be acquired.
- concentration data may be acquired by measuring concentration values from blood collected from an evaluation object by, for example, the following measurement method (A), (B), or (C).
- the unit of the concentration value may be, for example, a molar concentration, a weight concentration, or an enzyme activity, and may be obtained by adding / subtracting / dividing an arbitrary constant to / from these concentrations.
- you may use the peak area or peak height value of each substance in the chromatogram obtained from the mass spectrometer instead of the concentration value.
- Plasma is separated from blood by centrifuging the collected blood sample.
- sulfosalicylic acid is added to remove the protein, and then the concentration value is analyzed by an amino acid analyzer based on the post-column derivatization method using a ninhydrin reagent.
- C The collected blood sample is subjected to blood cell separation using a membrane, MEMS technology, or the principle of centrifugation to separate plasma or serum from the blood. Plasma or serum samples that are not measured immediately after plasma or serum are obtained are stored frozen at ⁇ 80 ° C. until the concentration is measured.
- concentration values use molecules that react or bind to target amino acids or amino acid-related metabolites, such as enzymes and aptamers, and analyze concentration values by quantifying substances that increase or decrease due to substrate recognition and spectroscopic values. To do.
- step S12 using at least one concentration value of the 23 types of amino acids and the 14 types of amino acid-related metabolites included in the concentration data acquired in step S11, MCI and / or AD for the evaluation target. Is evaluated (step S12). Note that before executing step S12, data such as missing values and outliers may be removed from the density data acquired in step S11.
- evaluating the state means, for example, examining the current state.
- the concentration data to be evaluated is acquired in step S11, and in step S12, the 23 types of amino acids and 14 described above are included in the concentration data to be evaluated acquired in step S11.
- the concentration value of at least one of the types of amino acid-related metabolites is evaluated for the evaluation target. This makes it possible to provide highly reliable information that can be used as a reference when knowing the state of MCI and / or AD.
- the evaluation method according to the present embodiment is useful as a simple and inexpensive MCI and / or AD determination inspection method suitable for mass screening.
- the concentration value of at least one of the 23 types of amino acids and the 14 types of amino acid-related metabolites reflects the state of MCI and / or AD for the evaluation target
- the density value may be converted by, for example, the following method, and the converted value may be determined to reflect the MCI and / or AD state of the evaluation target.
- the density value or the converted value itself may be treated as an evaluation result related to the MCI and / or AD state for the evaluation target.
- the possible range of the density value is a predetermined range (for example, a range from 0.0 to 1.0, a range from 0.0 to 10.0, a range from 0.0 to 100.0, or -10.0 to
- a predetermined range for example, a range from 0.0 to 1.0, a range from 0.0 to 10.0, a range from 0.0 to 100.0, or -10.0 to
- an arbitrary value is added / subtracted / divided / divided from / to the density value, or the density value is converted into a predetermined conversion method (for example, exponential conversion, logarithmic conversion). , Angle conversion, square root conversion, probit conversion, reciprocal conversion, Box-Cox conversion, or power conversion), or by combining these calculations for the density value. It may be converted.
- the value of an exponential function with the concentration value as an index and the Napier number as the base may be affected by a predetermined state (for example, MCI and / or AD may be affected).
- a predetermined state for example, MCI and / or AD may be affected.
- the density value may be converted so that the converted value when the sensitivity is 95% is 5.0 and the converted value when the sensitivity is 80% is 8.0.
- the concentration distribution may be converted into a normal distribution and then converted into a deviation value so that the average is 50 and the standard deviation is 10. These conversions may be performed by gender or age.
- the state of MCI and / or AD may be evaluated with respect to the evaluation target using the value obtained by converting the density value by, for example, the conversion method described above.
- position information regarding the position of a predetermined mark on a predetermined ruler that is visible on a display device such as a monitor or a physical medium such as paper is obtained from the 23 types of amino acids and the 14 types of amino acid-related metabolites. If at least one density value or a density value after conversion is converted, it is generated using the converted value, and the generated position information reflects the MCI and / or AD state of the evaluation target You may decide.
- the predetermined ruler is for evaluating the state of MCI and / or AD.
- the ruler is a ruler with a scale, and “a density value or a range that can be obtained after conversion, or , A part corresponding to the upper limit value and the lower limit value in “a part of the range”.
- the predetermined mark corresponds to the density value or the value after conversion, and is, for example, a circle mark or a star mark.
- the concentration value of at least one of the 23 types of amino acids and the 14 types of amino acid-related metabolites is a predetermined value (mean value ⁇ 1SD, 2SD, 3SD, N quantile, N percentile, or clinical significance.
- the state of MCI and / or AD may be evaluated with respect to the evaluation object when the value is lower than or lower than a predetermined value) or higher than the predetermined value or higher than the predetermined value.
- the concentration value itself but the deviation value (the value obtained by standardizing the concentration distribution by gender for each amino acid and each amino acid-related metabolite and then making the deviation value so that the average is 50 and the standard deviation is 10) May be used.
- the degree of possibility that the evaluation target is affected by MCI and / or AD may be qualitatively evaluated. Specifically, using at least one concentration value of the 23 types of amino acids and the 14 types of amino acid-related metabolites and one or more preset thresholds, the evaluation target is determined as MCI and / or You may classify
- a plurality of categories are categories for belonging to subjects who are highly likely to be affected by MCI and / or AD (for example, subjects considered to be affected by MCI and / or AD).
- Categorization and / or MCI and / or AD to belong to subjects with a low likelihood of suffering from MCI and / or AD (eg, subjects deemed not to have MCI and / or AD)
- a category may be included for belonging to subjects with a moderate likelihood of being affected.
- a plurality of categories include a category for assigning a subject having a high possibility of suffering from MCI and / or AD and a subject having a low possibility of suffering from MCI and / or AD.
- a section for belonging may be included.
- the density value may be converted by a predetermined method, and the evaluation target may be classified into any one of a plurality of categories using the converted value.
- Albumin total protein, triglyceride (neutral fat), HbA1c, glycated albumin, insulin resistance index, total cholesterol, LDL cholesterol, HDL cholesterol, amylase, total bilirubin, creatinine, estimated glomerular filtration rate (eGFR), uric acid, GOT (AST), GPT (ALT), GGTP ( ⁇ -GTP), glucose (blood glucose level), CRP (C-reactive protein), red blood cells, hemoglobin, hematocrit, MCV, MCH, MCHC, white blood cells, platelet count, etc.
- FIG. 2 is a principle configuration diagram showing the basic principle of the second embodiment.
- the description overlapping the first embodiment described above may be omitted.
- the control unit is included in the concentration data of the evaluation target (for example, an individual such as an animal or a human) acquired in advance regarding the concentration value of at least one of the 23 types of amino acids and the 14 types of amino acid-related metabolites in the blood.
- the state of MCI and / or AD is evaluated for the evaluation target using the at least one concentration value (step S21). This makes it possible to provide highly reliable information that can be used as a reference when knowing the state of MCI and / or AD.
- FIG. 3 is a diagram showing an example of the overall configuration of the present system.
- the present system includes an evaluation device 100 that evaluates the MCI and / or AD state of an individual to be evaluated, and a client device 200 that provides individual concentration data (corresponding to the terminal device of the present invention). ) Are communicably connected via the network 300.
- the network 300 has a function of connecting the evaluation apparatus 100 and the client apparatus 200 so that they can communicate with each other, such as the Internet, an intranet, or a LAN (including both wired and wireless).
- the network 300 includes a VAN, a personal computer communication network, a public telephone network (including both analog / digital), a dedicated line network (including both analog / digital), a CATV network, and a mobile line switching network.
- mobile packet switching network including IMT2000 system, GSM (registered trademark) system or PDC / PDC-P system
- wireless paging network including local wireless network such as Bluetooth (registered trademark), PHS network, satellite A communication network (including CS, BS or ISDB) may be used.
- FIG. 4 is a block diagram showing an example of the configuration of the evaluation apparatus 100 of the present system, and conceptually shows only the portion related to the present invention in the configuration.
- the evaluation device 100 includes a control unit 102 such as a CPU (central processing unit) that controls the evaluation device in an integrated manner, a communication device such as a router, and a wired or wireless communication line such as a dedicated line.
- the communication interface unit 104 that is communicably connected to the network 300, the storage unit 106 that stores various databases, tables, and files, and the input / output interface unit 108 that is connected to the input device 112 and the output device 114 are configured. These units are communicably connected via an arbitrary communication path.
- the evaluation apparatus 100 may be configured in the same housing as various analysis apparatuses (for example, an amino acid analysis apparatus).
- a configuration (hardware and software) that calculates (measures) and outputs (prints, monitors, etc.) a concentration value of at least one of the 23 types of amino acids and the 14 types of amino acid-related metabolites in the blood.
- the small analyzer provided may further include an evaluation unit 102b to be described later, and output the result obtained by the evaluation unit 102b using the above configuration.
- the communication interface unit 104 mediates communication between the evaluation device 100 and the network 300 (or a communication device such as a router). That is, the communication interface unit 104 has a function of communicating data with other terminals via a communication line.
- the input / output interface unit 108 is connected to the input device 112 and the output device 114.
- a monitor including a home television
- a speaker or a printer can be used as the output device 114 (hereinafter, the output device 114 may be described as the monitor 114).
- the input device 112 a monitor that realizes a pointing device function in cooperation with a mouse can be used in addition to a keyboard, a mouse, and a microphone.
- the storage unit 106 is a storage means, and for example, a memory device such as a RAM / ROM, a fixed disk device such as a hard disk, a flexible disk, an optical disk, or the like can be used.
- the storage unit 106 stores a computer program for giving instructions to the CPU and performing various processes in cooperation with an OS (Operating System). As illustrated, the storage unit 106 stores a density data file 106a and an evaluation result file 106b.
- the concentration data file 106a stores at least one concentration value of the 23 types of amino acids and the 14 types of amino acid-related metabolites in the blood.
- FIG. 5 is a diagram showing an example of information stored in the density data file 106a.
- the information stored in the density data file 106a is configured by associating an individual number for uniquely identifying an individual (sample) to be evaluated with density data.
- the density data is handled as a numerical value, that is, a continuous scale, but the density data may be a nominal scale or an order scale. In the case of a nominal scale or an order scale, analysis may be performed by giving an arbitrary numerical value to each state. Moreover, you may combine the value regarding other biological information with density
- concentration data may be used as a numerical value, that is, a continuous scale, but the density data may be a nominal scale or an order scale. In the case of a nominal scale or an order scale, analysis may be performed by giving an arbitrary numerical value to each state. Moreover, you may combine the value regarding other biological information
- FIG. 6 is a diagram illustrating an example of information stored in the evaluation result file 106b.
- Information stored in the evaluation result file 106b includes an individual number for uniquely identifying an individual (sample) to be evaluated, concentration data of the individual acquired in advance, and an evaluation result regarding the MCI and / or AD state ( For example, a value obtained by converting a density value by the conversion unit 102b1 described later, position information generated by the generation unit 102b2 described later, or a classification result obtained by the classification unit 102b3 described later, and the like are associated with each other. Configured.
- control unit 102 has an internal memory for storing a control program such as an OS, a program that defines various processing procedures, and necessary data, and various information processing based on these programs. Execute. As shown in the figure, the control unit 102 is roughly divided into a reception unit 102a, an evaluation unit 102b, a result output unit 102c, and a transmission unit 102d. The control unit 102 also performs data processing such as removal of data with missing values, removal of data with many outliers, and removal of variables with many data with missing values on the density data transmitted from the client device 200. .
- data processing such as removal of data with missing values, removal of data with many outliers, and removal of variables with many data with missing values on the density data transmitted from the client device 200.
- the receiving unit 102 a receives information (specifically, density data, etc.) transmitted from the client device 200 via the network 300.
- the evaluation unit 102b uses the concentration value of at least one of the 23 types of amino acids and the 14 types of amino acid-related metabolites included in the concentration data of the individual received by the receiving unit 102a to determine the MCI and / or Or evaluate the state of AD.
- FIG. 7 is a block diagram showing the configuration of the evaluation unit 102b, and conceptually shows only the portion related to the present invention.
- the evaluation unit 102b further includes a conversion unit 102b1, a generation unit 102b2, and a classification unit 102b3.
- the conversion unit 102b1 converts at least one concentration value of the 23 types of amino acids and the 14 types of amino acid-related metabolites included in the concentration data by, for example, the conversion method described above.
- the evaluation unit 102b may store the value after conversion by the conversion unit 102b1 as a result of evaluation in a predetermined storage area of the evaluation result file 106b.
- the generation unit 102b2 converts the position information related to the position of the predetermined mark on the predetermined ruler that is visibly displayed on a display device such as a monitor or a physical medium such as paper, by the conversion unit 102b1. Generate using later values.
- the evaluation unit 102b may store the position information generated by the generation unit 102b2 as an evaluation result in a predetermined storage area of the evaluation result file 106b.
- the classification unit 102b3 is defined using at least the degree of possibility of suffering from MCI and / or AD using the concentration value or the value after the concentration value is converted by the conversion unit 102b1. Classify into one of multiple categories.
- the result output unit 102c outputs the processing result (including the evaluation result obtained by the evaluation unit 102b) in each processing unit of the control unit 102 to the output device 114.
- the transmission unit 102d is a unit that transmits data to an external device, and transmits, for example, the evaluation result obtained by the evaluation unit 102b to the client device 200 that is the transmission source of the individual concentration data.
- FIG. 8 is a block diagram showing an example of the configuration of the client apparatus 200 of the present system, and conceptually shows only the portion related to the present invention in the configuration.
- the client device 200 includes a control unit 210, a ROM 220, an HD 230, a RAM 240, an input device 250, an output device 260, an input / output IF 270, and a communication IF 280. These units are communicably connected via an arbitrary communication path. Has been.
- the control unit 210 includes a reception unit 211 and a transmission unit 212.
- the receiving unit 211 receives various types of information such as an evaluation result transmitted from the evaluation device 100 via the communication IF 280.
- the transmission unit 212 transmits various types of information such as individual concentration data to the evaluation apparatus 100 via the communication IF 280.
- the control unit 210 includes an evaluation unit 210a (including a conversion unit 210a1, a generation unit 210a2, and a classification unit 210a3) having the same function as the function of the evaluation unit 102b provided in the control unit 102 of the evaluation apparatus 100. You may have.
- the input device 250 is a keyboard, a mouse, a microphone, or the like.
- a monitor 261 which will be described later, also realizes a pointing device function in cooperation with the mouse.
- the output device 260 is an output unit that outputs information received via the communication IF 280, and includes a monitor (including a home television) 261 and a printer 262. In addition, the output device 260 may be provided with a speaker or the like.
- the input / output IF 270 is connected to the input device 250 and the output device 260.
- the communication IF 280 connects the client device 200 and the network 300 (or a communication device such as a router) so that they can communicate with each other.
- the client device 200 is connected to the network 300 via a communication device such as a modem, TA, or router and a telephone line, or via a dedicated line.
- the client apparatus 200 can access the evaluation apparatus 100 according to a predetermined communication protocol.
- an information processing device for example, a known personal computer, workstation, home game device, Internet TV, PHS terminal, portable terminal, mobile body
- peripheral devices such as a printer, a monitor, and an image scanner as necessary.
- the client device 200 may be realized by mounting software (including programs, data, and the like) that realizes various processing functions provided in the control unit 210 in a communication terminal / information processing terminal such as a PDA).
- control unit 210 may be realized by a CPU and a program that is interpreted and executed by the CPU and all or any part of the processing performed by the control unit.
- the ROM 220 or the HD 230 stores computer programs for giving instructions to the CPU in cooperation with the OS and performing various processes.
- the computer program is executed by being loaded into the RAM 240, and constitutes the control unit 210 in cooperation with the CPU.
- the computer program may be recorded in an application program server connected to the client apparatus 200 via an arbitrary network, and the client apparatus 200 may download all or a part thereof as necessary.
- all or any part of the processing performed by the control unit 210 may be realized by hardware such as wired logic.
- the evaluation apparatus 100 includes evaluation of individuals based on concentration data (conversion to concentration values, generation of position information, and classification into individual categories from reception of concentration data. ) And the transmission of the evaluation result, and the client device 200 receives the evaluation result as an example.
- the client device 200 includes the evaluation unit 210a
- the density value Conversion, generation of position information, classification into individual sections, and the like may be executed by appropriately sharing between the evaluation apparatus 100 and the client apparatus 200.
- the evaluation unit 210a when the client device 200 receives a value after converting the density value from the evaluation device 100, the evaluation unit 210a generates position information corresponding to the converted value in the generation unit 210a2, or in the classification unit 210a3.
- An individual may be classified into any one of a plurality of sections using the converted value. Further, for example, when the client device 200 receives the value and the position information after converting the density value from the evaluation device 100, the evaluation unit 210a uses the converted value in the classification unit 210a3 to classify the individual into a plurality of categories. You may classify
- each illustrated component is functionally conceptual and does not necessarily need to be physically configured as illustrated.
- all or some of the processing functions provided in the evaluation apparatus 100 may be realized by a CPU and a program interpreted and executed by the CPU. Alternatively, it may be realized as hardware by wired logic.
- the program is recorded on a non-transitory computer-readable recording medium including programmed instructions for causing the information processing apparatus to execute the evaluation method according to the present invention, and is stored in the evaluation apparatus 100 as necessary. Read mechanically. That is, in the storage unit 106 such as a ROM or an HDD, computer programs for giving instructions to the CPU in cooperation with the OS and performing various processes are recorded. This computer program is executed by being loaded into the RAM, and constitutes a control unit in cooperation with the CPU.
- the computer program may be stored in an application program server connected to the evaluation apparatus 100 via an arbitrary network, and may be downloaded in whole or in part as necessary. .
- the evaluation program according to the present invention may be stored in a computer-readable recording medium that is not temporary, and may be configured as a program product.
- the “recording medium” means a memory card, USB memory, SD card, flexible disk, magneto-optical disk, ROM, EPROM, EEPROM (registered trademark), CD-ROM, MO, DVD, and Blu-ray. (Registered trademark) It shall include any “portable physical medium” such as Disc.
- the “program” is a data processing method described in an arbitrary language or description method, and may be in any form such as source code or binary code. Note that the “program” is not necessarily limited to a single configuration, and functions are achieved in cooperation with a separate configuration such as a plurality of modules and libraries or a separate program represented by the OS. Including things. In addition, a well-known structure and procedure can be used about the specific structure and reading procedure for reading a recording medium in each apparatus shown to embodiment, the installation procedure after reading, etc.
- Various databases and the like stored in the storage unit are storage means such as a memory device such as a RAM and a ROM, a fixed disk device such as a hard disk, a flexible disk, and an optical disk. Stores programs, tables, databases, web page files, and the like.
- the evaluation apparatus 100 may be configured as an information processing apparatus such as a known personal computer or workstation, or may be configured as the information processing apparatus connected to an arbitrary peripheral device.
- the evaluation apparatus 100 may be realized by installing software (including a program or data) that causes the information processing apparatus to realize the evaluation method of the present invention.
- the specific form of the distribution / integration of the devices is not limited to the one shown in the figure, and all or a part of them may be functionally or physically in arbitrary units according to various additions or according to the functional load. It can be configured to be distributed and integrated. That is, the above-described embodiments may be arbitrarily combined and may be selectively implemented.
- AUC area under the curve
- ROC_AUC receiver characteristic curve
- a blood sample of an elderly person 65 years or older with normal cognitive function and a blood sample of an elderly person diagnosed with MCI were obtained (total of 60 cases).
- blood samples blood concentrations (mol / ml) of 23 amino acids were measured using the same measurement method as in Example 1.
- a blood sample of an elderly person 65 years or older with normal cognitive function and a blood sample of an elderly person diagnosed with MCI were obtained (total of 60 cases).
- 13 amino acid-related metabolites GABA, Sarcosine, Serotonin, Permidine, Phosphoethanomine, S-Adenosyl-homocylsteine, L-Homocitrulline-Nemospirulline, , 3-hydroxykynureline, Phosphorine, Hypotaurine, 3-Aminobutanoic acid, Asymmetric dimethylarginine
- the same diagnostic criteria as in Example 2 were used for MCI.
- the present invention can be widely implemented in many industrial fields, particularly pharmaceuticals, foods, and medical fields, and is extremely useful.
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Abstract
Description
(略称) (正式名称)
α-ABA α-Aminobutyric acid
Ala Alanine
Arg Arginine
Asn Asparagine
Cit Citrulline
Gln Glutamine
Glu Glutamic acid
Gly Glycine
His Histidine
Ile Isoleucine
Leu Leucine
Lys Lysine
Met Methionine
Orn Ornithine
Phe Phenylalanine
Pro Proline
Ser Serine
Thr Threonine
Trp Tryptophan
Tyr Tyrosine
Val Valine
[1-1.第1実施形態の概要]
ここでは、第1実施形態の概要について図1を参照して説明する。図1は第1実施形態の基本原理を示す原理構成図である。
(A)採取した血液サンプルを遠心することにより血液から血漿を分離する。全ての血漿サンプルは、濃度値の測定時まで-80℃で凍結保存する。濃度値測定時には、アセトニトリルを添加し除蛋白処理を行った後、標識試薬(3-アミノピリジル-N-ヒドロキシスクシンイミジルカルバメート)を用いてプレカラム誘導体化を行い、そして、液体クロマトグラフ質量分析計(LC/MS)により濃度値を分析する(国際公開第2003/069328号、国際公開第2005/116629号を参照)。
(B)採取した血液サンプルを遠心することにより血液から血漿を分離する。全ての血漿サンプルは、濃度値の測定時まで-80℃で凍結保存する。濃度値測定時には、スルホサリチル酸を添加し除蛋白処理を行った後、ニンヒドリン試薬を用いたポストカラム誘導体化法を原理としたアミノ酸分析計により濃度値を分析する。
(C)採取した血液サンプルを、膜やMEMS技術または遠心分離の原理を用いて血球分離を行い、血液から血漿または血清を分離する。血漿または血清取得後すぐに濃度値の測定を行わない血漿または血清サンプルは、濃度値の測定時まで-80℃で凍結保存する。濃度値測定時には、酵素やアプタマーなど、標的とするアミノ酸又はアミノ酸関連代謝物と反応または結合する分子等を用い、基質認識によって増減する物質や分光学的値を定量等することにより濃度値を分析する。
濃度値の取り得る範囲が所定範囲(例えば0.0から1.0までの範囲、0.0から10.0までの範囲、0.0から100.0までの範囲、又は-10.0から10.0までの範囲、など)に収まるようにする等のために、例えば、濃度値に対して任意の値を加減乗除したり、濃度値を所定の変換手法(例えば、指数変換、対数変換、角変換、平方根変換、プロビット変換、逆数変換、Box-Cox変換、又はべき乗変換など)で変換したり、また、濃度値に対してこれらの計算を組み合わせて行ったりすることで、濃度値を変換してもよい。例えば、濃度値を指数としネイピア数を底とする指数関数の値(具体的には、MCI及び/又はADの状態が所定の状態(例えば、MCI及び/又はADに罹患している可能性が高い状態、など)である確率pを定義したときの自然対数ln(p/(1-p))が濃度値と等しいとした場合におけるp/(1-p)の値)をさらに算出してもよく、また、算出した指数関数の値を1と当該値との和で割った値(具体的には、確率pの値)をさらに算出してもよい。
また、特定の条件のときの変換後の値が特定の値となるように、濃度値を変換してもよい。例えば、感度が95%のときの変換後の値が5.0となり且つ感度が80%のときの変換後の値が8.0となるように濃度値を変換してもよい。
また、各アミノ酸及びアミノ酸関連代謝物ごとに、濃度分布を正規分布化した後、平均50、標準偏差10となるように偏差値化してもよい。
なお、これらの変換は、男女別や年齢別に行ってもよい。
1.アミノ酸以外の他の血中の代謝物(アミノ酸代謝物・糖類・脂質等)、タンパク質、ペプチド、ミネラル、ビタミン、有機酸、ホルモン等の濃度値
2.アルブミン、総蛋白、トリグリセリド(中性脂肪)、HbA1c、糖化アルブミン、インスリン抵抗性指数、総コレステロール、LDLコレステロール、HDLコレステロール、アミラーゼ、総ビリルビン、クレアチニン、推算糸球体濾過量(eGFR)、尿酸、GOT(AST)、GPT(ALT),GGTP(γ-GTP)、グルコース(血糖値)、CRP(C反応性蛋白)、赤血球、ヘモグロビン、ヘマトクリット、MCV、MCH,MCHC、白血球、血小板数等の血液検査値
3.超音波エコー、X線、CT、MRI、内視鏡像等の画像情報から得られる値
4.年齢、身長、体重、BMI、腹囲、収縮期血圧、拡張期血圧、性別、喫煙情報、食事情報、飲酒情報、運動情報、ストレス情報、睡眠情報、家族の既往歴情報、疾患歴情報(糖尿病等)等の生体指標に関する値
5.アルツハイマー型認知症のリスク遺伝子(APOEε4アリル等)の保有数等の遺伝子情報から得られる値
[2-1.第2実施形態の概要]
ここでは、第2実施形態の概要について図2を参照して説明する。図2は第2実施形態の基本原理を示す原理構成図である。なお、本第2実施形態の説明では、上述した第1実施形態と重複する説明を省略する場合がある。
ここでは、第2実施形態にかかる評価システム(以下では本システムと記す場合がある。)の構成について、図3から図8を参照して説明する。なお、本システムはあくまでも一例であり、本発明はこれに限定されない。
本発明にかかる評価装置、評価方法、評価プログラム、評価システム及び端末装置は、上述した第2実施形態以外にも、特許請求の範囲に記載した技術的思想の範囲内において種々の異なる実施形態にて実施されてよいものである。
102 制御部
102a 受信部
102b 評価部
102b1 変換部
102b2 生成部
102b3 分類部
102c 結果出力部
102d 送信部
104 通信インターフェース部
106 記憶部
106a 濃度データファイル
106b 評価結果ファイル
108 入出力インターフェース部
112 入力装置
114 出力装置
200 クライアント装置(端末装置(情報通信端末装置))
300 ネットワーク
Claims (7)
- 評価対象の血液中のα-ABA、Ala、Arg、Asn、Cit、Gln、Glu、Gly、His、Ile、Leu、Lys、Met、Orn、Phe、Pro、Ser、Thr、Trp、Tyr、Val、Cysteine、Taurine、GABA、Hypotaurine、S-Adenosyl homocysiteine、Sarcosine、Serotonin、Spermidine、hCit、3-hKyn、aAiBA、N8-Acetylspermidine、Phosphoserine、bABA、ADMA及びThioprolineのうちの少なくとも1つの濃度値を用いて、前記評価対象について軽度認知障害又はアルツハイマー型認知症の状態を評価する評価ステップを含むこと、
を特徴とする評価方法。 - 制御部を備えた評価装置であって、
前記制御部は、
評価対象の血液中のα-ABA、Ala、Arg、Asn、Cit、Gln、Glu、Gly、His、Ile、Leu、Lys、Met、Orn、Phe、Pro、Ser、Thr、Trp、Tyr、Val、Cysteine、Taurine、GABA、Hypotaurine、S-Adenosyl homocysiteine、Sarcosine、Serotonin、Spermidine、hCit、3-hKyn、aAiBA、N8-Acetylspermidine、Phosphoserine、bABA、ADMA及びThioprolineのうちの少なくとも1つの濃度値を用いて、前記評価対象について軽度認知障害又はアルツハイマー型認知症の状態を評価する評価手段
を備えたこと、
を特徴とする評価装置。 - 制御部を備えた情報処理装置において実行される評価方法であって、
前記制御部において実行される、
評価対象の血液中のα-ABA、Ala、Arg、Asn、Cit、Gln、Glu、Gly、His、Ile、Leu、Lys、Met、Orn、Phe、Pro、Ser、Thr、Trp、Tyr、Val、Cysteine、Taurine、GABA、Hypotaurine、S-Adenosyl homocysiteine、Sarcosine、Serotonin、Spermidine、hCit、3-hKyn、aAiBA、N8-Acetylspermidine、Phosphoserine、bABA、ADMA及びThioprolineのうちの少なくとも1つの濃度値を用いて、前記評価対象について軽度認知障害又はアルツハイマー型認知症の状態を評価する評価ステップ
を含むこと、
を特徴とする評価方法。 - 制御部を備えた情報処理装置において実行させるための評価プログラムであって、
前記制御部において実行させるための、
評価対象の血液中のα-ABA、Ala、Arg、Asn、Cit、Gln、Glu、Gly、His、Ile、Leu、Lys、Met、Orn、Phe、Pro、Ser、Thr、Trp、Tyr、Val、Cysteine、Taurine、GABA、Hypotaurine、S-Adenosyl homocysiteine、Sarcosine、Serotonin、Spermidine、hCit、3-hKyn、aAiBA、N8-Acetylspermidine、Phosphoserine、bABA、ADMA及びThioprolineのうちの少なくとも1つの濃度値を用いて、前記評価対象について軽度認知障害又はアルツハイマー型認知症の状態を評価する評価ステップ
を含むこと、
を特徴とする評価プログラム。 - 制御部を備えた評価装置と制御部を備えた端末装置とをネットワークを介して通信可能に接続して構成された評価システムであって、
前記端末装置の前記制御部は、
評価対象の血液中のα-ABA、Ala、Arg、Asn、Cit、Gln、Glu、Gly、His、Ile、Leu、Lys、Met、Orn、Phe、Pro、Ser、Thr、Trp、Tyr、Val、Cysteine、Taurine、GABA、Hypotaurine、S-Adenosyl homocysiteine、Sarcosine、Serotonin、Spermidine、hCit、3-hKyn、aAiBA、N8-Acetylspermidine、Phosphoserine、bABA、ADMA及びThioprolineのうちの少なくとも1つの濃度値に関する濃度データを前記評価装置へ送信する濃度データ送信手段と、
前記評価装置から送信された、前記評価対象についての軽度認知障害又はアルツハイマー型認知症の状態に関する評価結果を受信する結果受信手段と、
を備え、
前記評価装置の前記制御部は、
前記端末装置から送信された前記濃度データを受信する濃度データ受信手段と、
前記濃度データ受信手段で受信した前記濃度データに含まれている前記少なくとも1つの濃度値を用いて、前記評価対象について軽度認知障害又はアルツハイマー型認知症の状態を評価する評価手段と、
前記評価手段で得られた前記評価結果を前記端末装置へ送信する結果送信手段と、
を備えたこと、
を特徴とする評価システム。 - 制御部を備えた端末装置であって、
前記制御部は、
評価対象についての軽度認知障害又はアルツハイマー型認知症の状態に関する評価結果を取得する結果取得手段
を備え、
前記評価結果は、前記評価対象の血液中のα-ABA、Ala、Arg、Asn、Cit、Gln、Glu、Gly、His、Ile、Leu、Lys、Met、Orn、Phe、Pro、Ser、Thr、Trp、Tyr、Val、Cysteine、Taurine、GABA、Hypotaurine、S-Adenosyl homocysiteine、Sarcosine、Serotonin、Spermidine、hCit、3-hKyn、aAiBA、N8-Acetylspermidine、Phosphoserine、bABA、ADMA及びThioprolineのうちの少なくとも1つの濃度値を用いて、前記評価対象について軽度認知障害又はアルツハイマー型認知症の状態を評価した結果であること、
を特徴とする端末装置。 - 端末装置とネットワークを介して通信可能に接続された、制御部を備えた評価装置であって、
前記制御部は、
前記端末装置から送信された、評価対象の血液中のα-ABA、Ala、Arg、Asn、Cit、Gln、Glu、Gly、His、Ile、Leu、Lys、Met、Orn、Phe、Pro、Ser、Thr、Trp、Tyr、Val、Cysteine、Taurine、GABA、Hypotaurine、S-Adenosyl homocysiteine、Sarcosine、Serotonin、Spermidine、hCit、3-hKyn、aAiBA、N8-Acetylspermidine、Phosphoserine、bABA、ADMA及びThioprolineのうちの少なくとも1つの濃度値に関する濃度データを受信する濃度データ受信手段と、
前記濃度データ受信手段で受信した前記濃度データに含まれている前記少なくとも1つの濃度値を用いて、前記評価対象について軽度認知障害又はアルツハイマー型認知症の状態を評価する評価手段と、
前記評価手段で得られた評価結果を前記端末装置へ送信する結果送信手段と、
を備えたこと、
を特徴とする評価装置。
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KR20190026743A (ko) | 2019-03-13 |
US20190277862A1 (en) | 2019-09-12 |
KR102362919B1 (ko) | 2022-02-16 |
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