US2021148898A1PendingUtilityA1

Detection of par in the csf of patients with parkinson's disease

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Assignee: UNIV JOHNS HOPKINSPriority: Jun 2, 2017Filed: Jun 1, 2018Published: May 20, 2021
Est. expiryJun 2, 2037(~10.8 yrs left)· nominal 20-yr term from priority
Inventors:Ted M. DawsonValina L. DawsonTae-In KamLiana RosenthalShaida Andrabi
G01N 2800/52G01N 2800/2835G01N 33/6896G01N 33/53C07K 2317/21C07K 16/44G01N 2500/20G01N 2333/91142G01N 33/5308
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Claims

Abstract

Poly(ADP-ribose) (PAR) is a protein implicated in numerous neurodegenerative disease states including Parkinson's disease (PD). To date, no routine laboratory test has been developed to diagnosis, assess or monitor patients suffering from PD. Disclosed herein a novel method to assess the PAR concentration in the cerebral spinal fluid (CSF) of a patient and correlate that concentration to the medical condition of a patient with PD. Also disclosed is the use of PAR as a biomarker for PD.

Claims

exact text as granted — not AI-modified
1 . A method for determining a poly(ADP-ribose) (PAR) concentration in cerebral spinal fluid (CSF), said method comprising
 collecting a sample of cerebrospinal fluid from a patient,   performing a PAR-sandwich ELISA on said CSF sample, thereby determining the PAR concentration in the CSF.   
     
     
         2 . The method according to  claim 1 , further comprising comparing the PAR concentration in said CSF sample to at least one control sample. 
     
     
         3 . The method according to  claim 1 , wherein the sandwich ELISA comprises at least at capture antibody and a detection antibody, and said capture antibody, said detection antibody or both are an anti-PAR monoclonal antibody. 
     
     
         4 . The method according to  claim 3 , wherein the capture antibody is attached to a solid support. 
     
     
         5 . The method according to  claim 3 , wherein the anti-PAR monoclonal antibody is fully human. 
     
     
         6 . The method according to  claim 1 , wherein comparing the PAR concentration in the CSF sample to at least one control sample is done by colorimetric assay. 
     
     
         7 . The method according to  claim 3 , wherein the detection antibody is conjugated to biotin. 
     
     
         8 . A method for determining the therapeutic efficacy of a medical treatment for Parkinson's disease, said method comprising
 collecting a sample of cerebrospinal fluid (CSF) from a patient receiving at least one medical treatment for PD,   measuring a poly(ADP-ribose) (PAR) concentration in said CSF sample, and   comparing the PAR concentration in said patient to a PAR concentration in at least one control sample.   
     
     
         9 . The method according to  claim 8 , wherein the control sample is a CSF sample collected from said patient at an earlier time period. 
     
     
         10 . The method according to  claim 8 , wherein the control sample is a CSF sample collected from a healthy donor. 
     
     
         11 . The method according to  claim 9 , wherein
 if the PAR concentration in said patient is higher than the PAR concentration in the control sample, then the medical treatment is not effective for said patient, and   if the PAR concentration in said patient is the same or lower than the PAR concentration in the control sample, then the medical treatment is effective for said patient.   
     
     
         12 . The method according to  claim 8 , wherein the medical treatment is administering to said patient one or more medicaments, performing surgery on said patient or a combination thereof. 
     
     
         13 . The method according to  claim 8 , wherein measuring the PAR concentration in said CSF sample is by sandwich ELISA. 
     
     
         14 . A method for monitoring the disease progression of a patient with Parkinson's disease (PD), said method comprising
 collecting a sample of cerebrospinal fluid (CSF) from a patient receiving at least one medical treatment for PD,   measuring a poly(ADP-ribose) (PAR) concentration in said CSF sample, and   comparing the PAR concentration in said patient to a PAR concentration in at least one control sample.   
     
     
         15 . The method according to  claim 14 , wherein the control sample is a CSF sample collected from said patient at an earlier time period. 
     
     
         16 . The method according to  claim 14 , wherein the control sample is a CSF sample collected from a healthy donor. 
     
     
         17 . The method according to  claim 15 , wherein
 if the PAR concentration in said patient is higher than the PAR concentration in the control sample, then the medical treatment is not effective for said patient, and   if the PAR concentration in said patient is the same or lower than the PAR concentration in the control sample, then the medical treatment is effective for said patient.   
     
     
         18 . The method according to  claim 14 , wherein the medical treatment is administering to said patient one or more pharmaceutical agents, performing surgery on said patient or a combination thereof. 
     
     
         19 . The method according to  claim 14 , wherein measuring the PAR concentration in said CSF sample is by sandwich ELISA. 
     
     
         20 . A method of diagnosing a patient with Parkinson's disease, said method comprising
 collecting a sample of cerebrospinal fluid (CSF) from a patient,   measuring a poly(ADP-ribose) (PAR) concentration in said CSF sample, and   comparing the PAR concentration in said patient to a PAR concentration in at least one control sample.   
     
     
         21 . The method according to  claim 20 , wherein the control sample is a CSF sample collected from said patient at an earlier time period. 
     
     
         22 . The method according to  claim 20 , wherein the control sample is a CSF sample collected from a healthy donor. 
     
     
         23 . The method according to  claim 21 , wherein
 if the PAR concentration in said patient is higher than the PAR concentration in the control sample, then said patient is at high risk for developing PD or has PD, and   if the PAR concentration in said patient is the same or lower than the PAR concentration in the control sample, then said patient is not at risk for developing PD or does not have PD.   
     
     
         24 . A theranostic method for Parkinson's disease, said method comprising
 collecting a sample of cerebrospinal fluid (CSF) from a patient who is receiving at least one medical treatment for PD,   measuring a poly(ADP-ribose) (PAR) concentration in said CSF sample,   comparing the PAR concentration in said patient to a PAR concentration in at least one control sample.   
     
     
         25 . The theranostic method according to  claim 24 , wherein the control sample is a CSF sample collected from said patient at an earlier time period. 
     
     
         26 . The theranostic method according to  claim 24 , wherein the control sample is a CSF sample collected from a healthy donor. 
     
     
         27 . The theranostic method according to  claim 25  wherein
 if the PAR concentration in said patient is higher than the PAR concentration in the control sample, then the method further comprises altering at least one medical treatment received by said patient, and 
 if the PAR concentration in said patient is the same or lower than the PAR concentration in the control sample, then the method further comprises not altering the medical treatment received by said patient. 
 
     
     
         28 . The method according to  claim 24 , wherein measuring the PAR concentration in said CSF sample is by sandwich ELISA.

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