US2020188335A1PendingUtilityA1

Metabolic Markers of Attention Deficit Hyperactivity Disorder

Assignee: LABORATORY CORP AMERICA HOLDINGSPriority: Feb 11, 2015Filed: Dec 13, 2019Published: Jun 18, 2020
Est. expiryFeb 11, 2035(~8.5 yrs left)· nominal 20-yr term from priority
G01N 33/5308A61K 31/4168G01N 2800/305A61K 31/165A61K 31/55G01N 2800/52A61K 31/138A61K 31/4458A61K 31/137
66
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Claims

Abstract

Disclosed herein are methods for treating subjects having ADHD identifiable by levels of 3-IS in blood.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 . A method for distinguishing between or among at least two conditions for diagnosis and/or risk assessment of an individual suspected of having or observed as having atypical development, wherein the at least two conditions comprise attention deficit hyperactivity disorder (ADHD) and non-attention deficit hyperactivity disorder (non-ADHD), the method comprising the steps of:
 measuring a level of 3-Indoxyl Sulfate (3-IS) in a biological sample obtained from the individual;   optionally identifying, by a processor of a computing device, a difference (e.g., an absolute difference or a relative difference) between (or ratio of) the measured 3-IS level and a predetermined control level; and   determining, by the processor, at least one of: (i) the existence of ADHD in the individual as opposed to at least one other condition exclusive of ADHD, wherein the at least one other condition comprises non-ADHD, said identifying based at least in part on the measured 3-IS level and/or the difference between the measured 3-IS level and the predetermined control level; and (ii) a likelihood the individual has ADHD as opposed to at least one other condition exclusive of ADHD, wherein the at least one other condition comprises non-ADHD, said identifying based at least in part on the measured 3-IS level and/or the difference between the measured 3-IS level and the predetermined control level.   
     
     
         2 . The method of  claim 1 , wherein the individual is independently suspected of having or is independently observed to have atypical development, said independent suspicion or observation having been made prior to the identifying step. 
     
     
         3 . The method of  claim 1 , comprising identifying, by the processor of the computing device, the existence of ADHD in the individual as opposed to non-ADHD. 
     
     
         4 . The method of  claim 1 , comprising identifying, by the processor of the computing device, a risk score quantifying the likelihood the individual has ADHD as opposed to at least one other condition, wherein the at least one other condition comprises non-ADHD. 
     
     
         5 . The method of  claim 1 , comprising identifying, by the processor of the computing device, a risk score quantifying the likelihood the individual has ADHD as opposed to non-ADHD. 
     
     
         6 . The method of  claim 1 , wherein the sample is a blood sample. 
     
     
         7 . The method of  claim 1 , wherein the sample comprises plasma. 
     
     
         8 . The method of  claim 1 , wherein the sample comprises white blood cells. 
     
     
         9 . The method of  claim 1 , wherein the individual has been identified by a medical practitioner as displaying atypical behavior prior to the identifying step. 
     
     
         10 . The method of  claim 1 , wherein the individual is five years old or less (e.g., three years old or less, 24 months old or less, or 20 months old or less). 
     
     
         11 . The method of  claim 1 , wherein the individual is male. 
     
     
         12 . A system for distinguishing between or among at least two conditions for diagnosis and/or risk assessment of an individual suspected of having or observed as having atypical development, wherein the at least two conditions comprise attention deficit hyperactivity disorder (ADHD) and non-attention deficit hyperactivity disorder (non-ADHD), the system comprising:
 a diagnostics kit comprising testing instruments for measuring a level of 3-Indoxyl Sulfate (3-IS) in a biological sample obtained from the individual; and   a non-transitory computer-readable medium having instructions stored thereon, wherein the instructions, when executed by a processor, cause the processor to:
 optionally, identify a difference (e.g., an absolute difference or a relative difference) between (or ratio of) the measured 3-IS level and a predetermined control level; and 
 determine at least one of: (i) the existence of ADHD in the individual as opposed to at least one other condition exclusive of ADHD, wherein the at least one other condition comprises non-ADHD, based at least in part on the measured 3-IS level and/or the difference between the measured 3-IS level and the predetermined control level; and (ii) a likelihood the individual has ADHD as opposed to at least one other condition exclusive of ADHD, wherein the at least one other condition comprises non-ADHD, based at least in part on the measured 3-IS level and/or the difference between the measured 3-IS level and the predetermined control level. 
   
     
     
         13 . The system of  claim 12 , wherein the diagnostics kit is an in vitro diagnostics kit. 
     
     
         14 . The system of  claim 12 , wherein the individual is independently suspected of having or is independently observed to have (e.g., by a medical practitioner) atypical development. 
     
     
         15 . The system of  claim 12 , wherein the instructions cause the processor to identify the existence of ADHD in the individual as opposed to non-ADHD. 
     
     
         16 . The system of  claim 12 , wherein the instructions cause the processor to identify a risk score quantifying the likelihood the individual has ADHD as opposed to at least one other condition, wherein the at least one other condition comprises non-ADHD. 
     
     
         17 . The system of  claim 12 , wherein the instructions cause the processor to identify a risk score quantifying the likelihood the individual has ADHD as opposed to non-ADHD. 
     
     
         18 - 24 . (canceled) 
     
     
         25 . The method of  claim 1 , wherein the method further comprises
 administering therapy to the individual that has been determined to have ADHD.   
     
     
         26 . The method of  claim 25 , wherein the therapy is behavioral therapy or a therapeutic substance. 
     
     
         27 - 33 . (canceled) 
     
     
         34 . A method for determining a condition for diagnosis and/or risk assessment of an individual suspected of having or observed as having atypical development, wherein the at least one condition comprises attention deficit hyperactivity disorder (ADHD), the method comprising the steps of:
 measuring a level of 3-Indoxyl Sulfate (3-IS) in a biological sample obtained from the individual;   optionally identifying, by a processor of a computing device, a difference between the measured 3-IS level and a predetermined control level; and   determining, by the processor, at least one of: (i) the existence of ADHD in the individual as opposed to the non-existence of ADHD, wherein the non-existence of ADHD comprises non-ADHD, said identifying based at least in part on the measured 3-IS level and/or the difference between the measured 3-IS level and the predetermined control level; and (ii) a likelihood the individual has ADHD as opposed to at least one other condition indicative of atypical development and exclusive of ADHD, wherein the at least one other condition does not comprise ADHD, said identifying based at least in part on the measured 3-IS level and/or the difference between the measured 3-IS level and the predetermined control level.

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