METHOD AND APPARATUS FOR IDENTIFYING A SAFE AND EFFICACIOUS DOSING REGIMEN
First Claim
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1. A method for measuring the responsiveness of a subject to a probe drug for the treatment of an attentional disorder in said subject, said method comprising:
- (a) testing said subject while unmedicated to produce baseline data for test MT0;
(b) following step (a), administering a first dose of probe drug to said subject;
(c) within two hours of performing step (b), testing said subject to produce medicated data for test MT1;
(d) following step (c), administering a second dose of probe drug to said subject;
(e) within two hours of performing step (d), testing said subject to produce medicated data for test MT2; and
(f) analyzing said data, wherein the analysis comprises scoring said baseline data and said medicated data to produce scored data; and
on the basis of said scored data determining whether the symptoms of said attentional disorder are ameliorated by said probe drug,wherein steps (a) through (e) are performed over a period of less than eight hours.
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Abstract
The invention features methods and systems to provide, in one test session, information on the patient'"'"'s sensitivity to a probe drug for treating attentional disorders. The methods and systems of the invention can enable clinicians and consumers to ascertain how much benefit an individual would derive from treatment, what dose would be required, and the acute effect of that dose on regularity and rhythmicity of their heartbeat.
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Citations
58 Claims
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1. A method for measuring the responsiveness of a subject to a probe drug for the treatment of an attentional disorder in said subject, said method comprising:
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(a) testing said subject while unmedicated to produce baseline data for test MT0; (b) following step (a), administering a first dose of probe drug to said subject; (c) within two hours of performing step (b), testing said subject to produce medicated data for test MT1; (d) following step (c), administering a second dose of probe drug to said subject; (e) within two hours of performing step (d), testing said subject to produce medicated data for test MT2; and (f) analyzing said data, wherein the analysis comprises scoring said baseline data and said medicated data to produce scored data; and
on the basis of said scored data determining whether the symptoms of said attentional disorder are ameliorated by said probe drug,wherein steps (a) through (e) are performed over a period of less than eight hours. - View Dependent Claims (4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 45, 56, 57)
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2. A method for measuring the responsiveness of a subject to a probe drug for the treatment of an attentional disorder in said subject, said method comprising:
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(a) testing said subject while unmedicated to produce baseline data for test MT0; (b) following step (a), administering a first dose of probe drug to said subject; (c) within two hours of performing step (b), testing said subject to produce medicated data for test MT1; (d) following step (c), administering a second dose of probe drug to said subject; (e) within two hours of performing step (d), testing said subject to produce medicated data for test MT2; and (f) transmitting said data to a computer for analysis, wherein said analysis comprises scoring said baseline data and said medicated data to produce scored data; and
on the basis of said scored data determining whether the symptoms of said attentional disorder are ameliorated by said probe drug,wherein steps (a) through (e) are performed over a period of less than eight hours.
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3. A method for measuring the responsiveness of a subject to a probe drug for the treatment of an attentional disorder in said subject, said method comprising:
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(i) providing data having been collected by the steps of; (a) testing said subject while unmedicated to produce baseline data for test MT0; (b) following step (a), administering a first dose of probe drug to said subject; (c) within two hours of performing step (b), testing said subject to produce medicated data for test MT1; (d) following step (c), administering a second dose of probe drug to said subject; and (e) within two hours of performing step (d), testing said subject to produce medicated data for test MT2, wherein steps (a) through (e) are performed over a period of less than eight hours; and (ii) performing an analysis, said analysis comprising scoring said baseline data and said medicated data to produce scored data, and on the basis of said scored data determining whether the symptoms of said attentional disorder are ameliorated by said probe drug.
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31. A system for measuring the responsiveness of a subject to a probe drug for the treatment of an attentional disorder, said system comprising:
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(i) a user interface for communicating the amounts of probe drug administered to said subject;
the timing of the doses; and
the timing of motor activity tests;(ii) a camera for tracking the movements of said subject'"'"'s head, leg, or foot to produce motor activity data; and (iii) an output component and program configured to transmit information to a computer for analysis, said information comprising the amounts of probe drug administered to said subject;
the timing of the doses;
the timing of the motor activity tests; and
the motor activity data.
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32. A system for measuring the responsiveness of a subject to a probe drug for the treatment of an attentional disorder, said system comprising:
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a monitor for generating visual images or a speaker for generating sounds; (ii) a device that is controllable by a subject; and (iii) a program for storing or transmitting information about the instances of device activation by said subject in response to said images or said sounds to a computer for analysis, said information comprising attention data and the timing of the collection of the attention data.
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33. A system for measuring the responsiveness of a subject to a probe drug for the treatment of an attentional disorder, said system comprising:
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an input component configured to receive information comprising the amounts of probe drug administered to said subject;
the timing of the doses;
the timing of subject testing; and
test data; and(ii) a processor provided with a computer program for (a) scoring said motor activity data to produce scored data, and (b) on the basis of said scored data, determining whether said subject is responsive to said probe drug.
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34-44. -44. (canceled)
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46-55. -55. (canceled)
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58-59. -59. (canceled)
Specification