# US 2019/0169690 A1 · Methods and compositions for diagnosis of alzheimer's disease

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- Number: US 2019/0169690 A1
- Document ID: US20190169690A1
- Status: Published application
- Kind: A1
- Application number: 16/218,863
- Filed: 2018-12-13
- Published: 2019-06-06
- Earliest claimed: 2011-08-16
- Assignees: Rosetta Genomics Ltd.
- Applicants: Rosetta Genomics Ltd.
- Inventors: Yaron Goren
- Web page: https://patentgrep.com/patent/US20190169690A1

## CPC

- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/158: Expression markers
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

The invention provides a method of diagnosing Alzheimer's disease (AD) in a subject by determining the level of expression of one or more miRNAs molecules associated with AD, as well as various nucleic acid molecules relating thereto or derived thereof.

## Claims

### Claim 1

A method of diagnosing Alzheimer's disease (AD) in a subject, the method comprising: obtaining a biological sample from a subject; determining an expression profile in said sample of a nucleic acid sequence selected from the group consisting of SEQ ID NOS: 1-67; a fragment thereof or a sequence having at least about 80% identity thereto; and comparing said expression profile to a reference expression profile wherein a difference in the level of expression profile in at least one or more nucleic acid sequence in said biological sample compared to said reference expression profile is diagnostic for AD.

### Claim 2 (depends on 1)

The method of claim 1, wherein relatively high expression levels of a nucleic acid sequence selected from the group consisting of SEQ ID NOS: 1-51; a fragment thereof and a sequence having at least about 80% identity thereto is diagnostic for AD.

### Claim 3 (depends on 1)

The method of claim 1, wherein relatively low expression levels of a nucleic acid sequence selected from the group consisting of SEQ ID NOS: 52-67; a fragment thereof and a sequence having at least about 80% identity thereto is diagnostic for AD.

### Claim 4 (depends on 1)

The method of claim 1, wherein said biological sample is selected from the group consisting of bodily fluid, a cell line and a tissue sample.

### Claim 5 (depends on 4)

The method of claim 4, wherein said bodily fluid sample is a serum sample.

### Claim 6 (depends on 4)

The method of claim 4, wherein said bodily fluid sample is a blood sample.

### Claim 7 (depends on 1)

The method of claim 1, wherein the method comprises determining the expression levels of at least two nucleic acid sequences.

### Claim 8 (depends on 7)

The method of claim 7, wherein the method further comprises combining one or more expression ratios of said nucleic acid sequences.

### Claim 9 (depends on 1)

The method of claim 1, wherein the expression levels are determined by a method selected from the group consisting of nucleic acid hybridization, nucleic acid amplification, and a combination thereof.

### Claim 10 (depends on 9)

The method of claim 9, wherein the nucleic acid amplification method is real-time PCR.

### Claim 11 (depends on 10)

The method of claim 10, wherein the real-time PCR method comprises forward and reverse primers.

### Claim 12 (depends on 11)

The method of claim 11, wherein the forward primer comprises a sequence selected from the group consisting of SEQ ID NOS: 68-134; a fragment thereof and a sequence having at least about 80% identity thereto.

### Claim 13 (depends on 12)

The method of claim 12, wherein the real-time PCR method further comprises a probe.

### Claim 14 (depends on 13)

The method of claim 13, wherein the probe comprises a nucleic acid sequence that is complementary to a sequence selected from the group consisting of SEQ ID NOS: 1-67; a fragment thereof and a sequence having at least about 80% identity thereto.

### Claim 15 (depends on 14)

The method of claim 14, wherein the probe comprises a nucleic acid sequence selected from the group consisting of SEQ ID NOS: 135-201; a fragment thereof and a sequence having at least about 80% identity thereto.

### Claim 16 (depends on 11)

The method of claim 11, wherein the reverse primer comprises SEQ ID NO: 202, a fragment thereof and a sequence having at least about 80% identity thereto.

### Claim 17

A kit for assessing AD in a subject, said kit comprising a probe comprising a nucleic acid sequence that is complementary to a sequence selected from the group consisting of SEQ ID NOS: 1-67; a fragment thereof and a sequence having at least about 80% identity thereto.

### Claim 18 (depends on 17)

The kit of claim 17, wherein the probe comprises a nucleic acid sequence selected from the group consisting of SEQ ID NOS: 135-201; a fragment thereof and a sequence having at least about 80% identity thereto.

### Claim 19 (depends on 17)

The kit of claim 17, wherein the kit further comprises a forward primer comprising a sequence selected from the group consisting of any one of SEQ ID NOS: 68-134; a fragment thereof and a sequence having at least about 80% identity thereto.

### Claim 20 (depends on 17)

The kit of claim 17, wherein the kit further comprises a reverse primer comprises SEQ ID NO: 202, a fragment thereof and a sequence having at least about 80% identity thereto.

### Claim 21 (depends on 1)

The method of claim 1, further comprising managing subject treatment based on the AD status.

### Claim 22 (depends on 21)

The method of claim 21, wherein managing subject treatment is selected from ordering further diagnostic tests and administering at least one therapeutic agent.