EP1527407A2 - Procede et programme informatique a moyens de code programme et produit programme informatique pour l'analyse d'une activite d'une preparation pharmaceutique - Google Patents

Procede et programme informatique a moyens de code programme et produit programme informatique pour l'analyse d'une activite d'une preparation pharmaceutique

Info

Publication number
EP1527407A2
EP1527407A2 EP03790651A EP03790651A EP1527407A2 EP 1527407 A2 EP1527407 A2 EP 1527407A2 EP 03790651 A EP03790651 A EP 03790651A EP 03790651 A EP03790651 A EP 03790651A EP 1527407 A2 EP1527407 A2 EP 1527407A2
Authority
EP
European Patent Office
Prior art keywords
pharmaceutical preparation
signals
influence
computer
neuronal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP03790651A
Other languages
German (de)
English (en)
Inventor
Gustavo Deco
Martin Stetter
Norbert Galm
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Siemens AG
Original Assignee
Siemens AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Siemens AG filed Critical Siemens AG
Publication of EP1527407A2 publication Critical patent/EP1527407A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/50—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16Z—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR
    • G16Z99/00—Subject matter not provided for in other main groups of this subclass

Definitions

  • the invention relates to an analysis of the effectiveness of a pharmaceutical preparation or medical preparation.
  • the new drug to be approved goes through various (test) phases, phase 1 to phase 3, during which the effectiveness of the new drug to be approved in combating a specific disease must be demonstrated.
  • side effects of the new drug to be approved as well as the effectiveness of the new drug to be approved are also compared with other correspondingly effective drugs.
  • the efficacy tests are usually carried out by studies on test subjects to whom the new drug to be approved is administered.
  • the effectiveness of the new drug is assessed on the basis of results from surveys, psychological tests and behavioral studies that are carried out with the test subjects.
  • the previously known magnetic resonance imaging (also magnetic resonance imaging, abbreviated: MR) is an imaging method that generates sectional images of the human body without the use of stressful X-rays.
  • the MR makes use of the behavior of the body tissue in a strong magnetic field. Pathological changes in the body tissue, for example in the brain or spinal cord, can be identified.
  • BOLD signal Blood Oxygenation Level Dependent
  • the result of the fMRI measurements shows the course of the activity of individual neuronal areas over a certain period of time, for example during cognitive processes as a result of certain perceptual processes or motor tasks.
  • SEM Structure Equation Modeling
  • the task of this analysis method described below is to identify the functional relationships between different brain areas described above in certain perception processes or motor tasks, in short the derivation of functional neuron structures for special tests.
  • This known analysis method is based on a predefined model of a brain, i.e. a predefined brain architecture.
  • the coupling matrix S has a (column / row) shape or shape defined in accordance with the given brain architecture.
  • An activity pattern is evaluated using a statistical method, such as "Structural Equation Modeling", or SEM for short, which generates statistical properties or key figures, such as the coupling quantities. These characterize a complex state of excitation of the neuron structure and thus enable it the evaluation and assessment of the effectiveness of the pharmaceutical preparation.
  • a neuronal model of the neuron structure is generated, which is reflected in a structure of the coupling sizes.
  • the signals are evaluated using a method based on "Structural Equation Modeling" (SEM), the changed coupling sizes being determined.
  • SEM Structuretural Equation Modeling
  • a SEN is known from [6].
  • the signals which can be analog or digital signals, can be determined by measurement, for example by measuring BOLD signals, or can also be read in from a memory or from a storage medium or from a D / A converter.
  • fMRI BOLD signals from a subject are measured. These are then evaluated using the statistical method.
  • Preparations can be completely different preparations or their composition of materials can vary. Differentiate, for example in such a way that active ingredient proportions in a preparation are increased or decreased.
  • FIG. 3 sketch according to an exemplary embodiment, which describes a procedure for determining the effectiveness of a pharmaceutical preparation using an fMRI.
  • FIG. 3 schematically shows the procedure or the conceptual interaction of various functional components in the determination and evaluation of an effectiveness of a pharmaceutical preparation using functional magnetic resonance imaging or magnetic resonance imaging (short: fMRI).
  • FIG. 3 shows a device 310 for performing a functional magnetic resonance tomography or magnetic resonance tomography (short: fMRI), a functional magnetic resonance tomograph or magnetic resonance tomograph 310 (cf. FIGS. 1, 100).
  • the drug to be evaluated in this case is a newly developed pharmaceutical 331 for the treatment of Alzheimer's.
  • the pharmaceutical 331 is evaluated in the context of a clinical study 330.
  • a study in an approval procedure for a new drug and a basic procedure for such a study, in particular the handling of test subjects and the administration of test preparations, is from [7] known.
  • the present study comprises two stages:
  • Tested here means that all study participants are each subjected to an fMRI.
  • the fMRI measurements of both groups are evaluated as described below, with what are known as coupling variables being determined, among other things.
  • the amount and nature of the changes i.e. the amount and type of changes in the values of the coupling sizes indicate a quantifiable effect or the effectiveness of the pharmaceutical being tested.
  • the magnetic resonance tomograph 100 has a patient table 130 which can be moved into the tube 110 and on which a patient is supported during an examination.
  • the magnetic resonance tomograph 100 has a control device 131, which enables the patient table 130 to be checked and controlled during the examination, for example a controlled insertion of the patient table 130 into the tube 120.
  • the magnetic resonance tomograph 100 has a measuring device 140 for measuring BOLD signals (Blood Oxygenation Level Dependent), an associated evaluation device 141 for evaluating the measured BOLD signals, in this case a high-performance computer, and an operating or interaction device 142 for operating personnel as well as a display device 143 for displaying an examination result.
  • BOLD signals Bood Oxygenation Level Dependent
  • an associated evaluation device 141 for evaluating the measured BOLD signals
  • an operating or interaction device 142 for operating personnel as well as a display device 143 for displaying an examination result.
  • the neuronal activity in areas of the brain of a patient can be measured, analyzed and a diagnosis can be derived therefrom on the basis of the fMRI technique.
  • the measuring device 140 measures the BOLD signal (Blood Oxygenation Level Dependent) in individual, selected areas of the patient's brain, which is related to the neuronal activity in the respective area.
  • the result of such fMRI measurements shows the course of the activity of the individual areas over a certain period of time, for example during cognitive processes as a result of certain perceptual processes or motor tasks which are to be carried out by the patient during an examination.
  • the fMRI measurements i.e. the BOLD signals measured in individual areas of the brain are analyzed.
  • the new analysis method brain activity is determined in the form of corresponding activation patterns in the areas examined in the brain and / or relationships between activation patterns in the areas examined and from this direct conclusions can be drawn about "normal" activity patterns or excitation states in the brain as well as functional disorders in the brain and their causes won.
  • the new analysis method provided by the evaluation device 140 is based on an expanded and more flexible model of the brain, the neuron structures in the brain and their behavior, in particular their interaction (FIGS. 3, 340), on the basis of which the measured BOLD signal is analyzed and is evaluated.
  • ⁇ ⁇ ⁇ C ⁇ , .-., C L , ⁇ ⁇ , ..., ⁇ L , ⁇ , ..., ⁇ L)
  • the optimal model parameters are determined using the maximum likelihood estimation [1] by optimizing or maximizing the probabilities (5) (240).
  • the parameters to be taken into account for the optimization process are the parameters of the selected higher order statistical distribution, in this case the weighted sum of the normal distributions, the model parameters sought and the statistical quantities, in this case the mean ⁇ and the covariance ⁇ from (6), the relationships between the model parameters and the statistical distribution (5) were established.

Abstract

L'invention concerne un procédé d'analyse d'une activité d'une préparation pharmaceutique ou d'un médicament sur une structure neuronale. Ledit procédé consiste à soumettre cette structure neuronale à l'influence d'une préparation pharmaceutique, à détecter des signaux décrivant des activités neuronales dans la structure neuronale située sous l'influence de cette préparation pharmaceutique puis à évaluer statistiquement ces signaux, de façon à déterminer des indices pour cette structure neuronale sous l'influence de ladite préparation pharmaceutique, lesquels indices décrivent l'activité de cette préparation.
EP03790651A 2002-08-09 2003-07-24 Procede et programme informatique a moyens de code programme et produit programme informatique pour l'analyse d'une activite d'une preparation pharmaceutique Withdrawn EP1527407A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10236630 2002-08-09
DE10236630 2002-08-09
PCT/DE2003/002497 WO2004021243A2 (fr) 2002-08-09 2003-07-24 Procede et programme informatique a moyens de code programme et produit programme informatique pour l'analyse d'une activite d'une preparation pharmaceutique

Publications (1)

Publication Number Publication Date
EP1527407A2 true EP1527407A2 (fr) 2005-05-04

Family

ID=31968957

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03790651A Withdrawn EP1527407A2 (fr) 2002-08-09 2003-07-24 Procede et programme informatique a moyens de code programme et produit programme informatique pour l'analyse d'une activite d'une preparation pharmaceutique

Country Status (3)

Country Link
US (1) US20060106543A1 (fr)
EP (1) EP1527407A2 (fr)
WO (1) WO2004021243A2 (fr)

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US10052497B2 (en) * 2005-07-22 2018-08-21 The Board Of Trustees Of The Leland Stanford Junior University System for optical stimulation of target cells
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CN106422081B (zh) 2010-11-05 2019-06-21 斯坦福大学托管董事会 用于光遗传学方法的光的上转换
CN106947741A (zh) 2010-11-05 2017-07-14 斯坦福大学托管董事会 光活化嵌合视蛋白及其使用方法
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Publication number Publication date
WO2004021243A3 (fr) 2004-10-14
WO2004021243A2 (fr) 2004-03-11
US20060106543A1 (en) 2006-05-18

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