# US 9,518,994 B2 · Method for diagnosing and monitoring schizophrenia and tauopathies

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- Number: US 9,518,994 B2
- Document ID: US9518994B2
- Status: Granted
- Kind: B2
- Application number: 13/520,390
- Filed: 2011-01-04
- Published: 2013-06-27
- Granted: 2016-12-13
- Earliest claimed: 2010-01-06
- Assignees: Ramot at Tel-Aviv University Ltd.
- Applicants: Illana Gozes; Efrat Dresner
- Inventors: Illana Gozes; Efrat Dresner
- Web page: https://patentgrep.com/patent/US9518994B2

## CPC

- G01N 33/6896: {Neurological disorders, e.g. Alzheimer's disease}
- G01N 2800/2814: Dementia; Cognitive disorders
- G01N 2800/2835: Movement disorders, e.g. Parkinson, Huntington, Tourette
- G01N 2800/302: Schizophrenia
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The present invention provides methods and kits for diagnosing or monitoring conditions such as schizophrenia and tauopathies in a patient by determining the level of ADNP1 or ADNP2 in a sample from the patient.

## Claims

### Claim 1

A method for assessing ADNP expression in a biological sample taken from a subject, comprising the steps of:
(1) performing an assay to determine ADNP1 mRNA level in the sample;
(2) performing an assay to determine ADNP2 mRNA level in the sample; and
(3) calculating the ratio of the ADNP1 mRNA level obtained in step (1) to the ADNP2 mRNA level obtained in step (2), wherein each of steps (1) and (2) comprises performing a reverse transcriptase polymerase reaction (RT-PCR), and wherein the primer set of SEQ ID NO: 1 and SEQ ID NO: 2 is used in step (1).

### Claim 2 (depends on 1)

The method of claim 1, wherein the sample is a brain sample, a blood sample, or a cerebrospinal fluid (CSF) sample.

### Claim 3 (depends on 2)

The method of claim 2, wherein the brain sample is taken from the hippocampus of the patient.

### Claim 4 (depends on 2)

The method of claim 2, wherein the brain sample is taken from the frontal cortex of the patient.

### Claim 5 (depends on 2)

The method of claim 2, wherein the blood sample is a whole blood, plasma, or serum sample.

### Claim 6 (depends on 1)

The method of claim 1, wherein the PCR in steps (1) and (2) is a quantitative real time PCR.

### Claim 7 (depends on 6)

The method of claim 6, wherein SYBER GREEN is used in the quantitative real time PCR.

### Claim 8 (depends on 1)

The method of claim 1, further comprising repeating steps (1) through (3) at later time with a second biological sample, the second biological sample being the same type of sample as the first biological sample and taken from the same subject.

### Claim 9 (depends on 1)

The method of claim 1, wherein the subject is an individual whose state of neurodegeneration or a metal disorder is being assessed.

### Claim 10

A method for assessing ADNP expression in a biological sample taken from a subject, comprising the steps of:
(1) performing an RT-PCR to determine ADNP1 mRNA level in the sample, wherein a primer of SEQ ID NO:1 or SEQ ID NO:2 is used in the PCR;
(2) performing an RT-PCR to determine ADNP2 mRNA level in the sample; and
(3) calculating the ratio of the ADNP1 mRNA level obtained in step (1) to the ADNP2 mRNA level obtained in step (2).

### Claim 11 (depends on 10)

The method of claim 10, wherein the sample is a brain sample, a blood sample, or a cerebrospinal fluid (CSF) sample.

### Claim 12 (depends on 11)

The method of claim 11, wherein the brain sample is taken from the hippocampus of the patient.

### Claim 13 (depends on 11)

The method of claim 11, wherein the brain sample is taken from the frontal cortex of the patient.

### Claim 14 (depends on 11)

The method of claim 11, wherein the blood sample is a whole blood, plasma, or serum sample.

### Claim 15 (depends on 10)

The method of claim 10, wherein the PCR in steps (1) and (2) is a quantitative real time PCR.

### Claim 16 (depends on 15)

The method of claim 15, wherein SYBER GREEN is used in the quantitative real time PCR.

### Claim 17 (depends on 10)

The method of claim 10, further comprising repeating steps (1) through (3) at later time with a second biological sample, the second biological sample being the same type of sample as the first biological sample and taken from the same subject.

### Claim 18 (depends on 10)

The method of claim 10, wherein the subject is an individual whose state of neurodegeneration or a metal disorder is being assessed.