# US 2021/0340624 A1 · Diagnostic marker of mci due to ad and uses thereof

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- Number: US 2021/0340624 A1
- Document ID: US20210340624A1
- Status: Published application
- Kind: A1
- Application number: 17/271,782
- Filed: 2019-07-12
- Published: 2021-11-04
- Earliest claimed: 2018-09-26
- Assignees: Shanghai Mental Health Center (Shanghai Psychological Counselling Training Center)
- Applicants: Shanghai Mental Health Center (Shanghai Psychological Counselling Training Center)
- Inventors: Tao Wang; Shifu Xiao; Haining He
- Web page: https://patentgrep.com/patent/US20210340624A1

## CPC

- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 1/686: Polymerase chain reaction [PCR]
- C12Q 2600/158: Expression markers
- C12Q 2600/166: Oligonucleotides used as internal standards, controls or normalisation probes
- C12Q 2600/178: miRNA, siRNA or ncRNA
- 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

Diagnostic markers for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) are provided. The marker being plasma miRNA including hsa-miR-1185-2-3p, hsa-miR-22-5p, hsa-miR-134-3p, hsa-miR-1909-3p and hsa-miR-107. The use of the marker and the corresponding kits are also provided. The beneficial effects are as follows: biomarkers with high diagnostic value for MCI due to AD are disclosed, which breaks through the dilemma of no convenient peripheral plasma diagnostic markers for MCI due to AD, and is conducive to the early diagnosis and early intervention of Alzheimer's disease, commonly known as senile dementia.

## Claims

### Claim 1

A diagnostic marker for mild cognitive impairment (MCI) due to Alzheimer's disease (AD), wherein the marker is plasma miRNA comprising hsa-miR-1185-2-3p, hsa-miR-22-5p, hsa-miR-134-3p, hsa-miR-1909-3p and hsa-miR-107.

### Claim 2 (depends on 1)

Use of the diagnostic marker for MCI due to AD according to claim 1 in the preparation of a diagnostic kit for MCI due to AD.

### Claim 3

A diagnostic kit for MCI due to AD, wherein the kit comprises reagents for measuring the content of hsa-miR-1185-2-3p, hsa-miR-22-5p, hsa-miR-134-3p, hsa-miR-1909-3p and hsa-miR-107 in a plasma sample.

### Claim 4 (depends on 3)

The diagnostic kit for MCI due to AD according to claim 3, wherein the kit further comprises primers and probes of hsa-miR-1185-2-3p, hsa-miR-22-5p, hsa-miR-134-3p, hsa-miR-1909-3p, and hsa-miR-107.

### Claim 5 (depends on 4)

The diagnostic kit for MCI due to AD according to claim 4, wherein the kit further comprises and internal control has-miR-93-5p.

### Claim 6 (depends on 3)

The diagnostic kit for MCI due to AD according to claim 3, wherein the formula for calculating the content of hsa-miR-1185-2-3p, hsa-miR-22-5p, hsa-miR-134-3p, hsa-miR-1909-3phsa-miR-107 in plasma measured by the kit is:
7.341−0.029×hsa-miR-134-3p−0.150×hsa-miR-22-5p−0.604×hsa-miR-1185-2-3p−5.321×hsa-miR-1909-3p−1.372×hsa-miR-107.

### Claim 7 (depends on 3)

A method of using the diagnostic kit for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) according to claim 3, comprising:
(1) extracting total RNA from a sample to be tested;
(2) using a miRNA reverse transcription kit to perform reverse transcription reaction on a extracted total RNA to obtain a corresponding cDNA;
(3) performing real-time fluorescent quantitative PCR with the cDNA, and using has-miR-93-5p as an internal control, detection result is expressed as ΔCt, wherein ΔCt=Ct microRNA-Ct has-miR-93-5p; and
(4) processing the result obtained according to a formula:
7.341−0.029×hsa-miR-134-3p−0.150×hsa-miR-22-5p−0.604×hsa-miR-1185-2-3p−5.321×hsa-miR-1909-3p−1.372×hsa-miR-107, and comparing a calculated value with 0.174.

### Claim 8 (depends on 7)

The method of claim 7 further comprising using primers and probes of hsa-miR-1185-2-3p, hsa-miR-22-5p, hsa-miR-134-3p, hsa-miR-1909-3p, and hsa-miR-107 to perform the reverse transcription reaction.