Method for diagnosis of Alzheimer's disease using microRNA

Inventors

Ryu, Jin-HyeobCho, Hyun-Jeong

Assignees

Biorchestra Co Ltd

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Publication Number

US-11198908-B2

Patent

Publication Date

2021-12-14

Expiration Date


Abstract

The present disclosure relates to a method for diagnosing or providing information for diagnosing Alzheimer's disease or a brain disease, and a composition and a diagnostic kit for diagnosing Alzheimer's disease or a brain disease using miR-485-3p. The present disclosure enables objective data analysis of the diagnosis of Alzheimer's disease or a brain disease by measuring the expression level of miR-485-3p in blood, minimizes risk to a patient by measuring the concentration of amyloid beta 42 in saliva, and enables quick and accurate diagnosis. Accordingly, the present disclosure is very useful for preventing Alzheimer's disease or a brain disease.

Core Innovation

The disclosure concerns diagnosing brain disease, including Alzheimer’s disease, and providing related diagnostic compositions and kits centered on measuring miR-485-3p expression in a sample from a subject. The diagnostic rationale links increased miR-485-3p expression in Alzheimer’s dementia patients with the stated biological context involving ELAVL2, APP, and amyloid beta 42 (Aβ42).

The disclosed approach also incorporates amyloid beta 42 (Aβ42) quantification for classification of cognitive impairment categories such as mild cognitive impairment (MCI) versus severe categories. Concentration ranges are described for Aβ42, including a normal range and thresholds defining MCI and severe categories, and these are used to support diagnostic categorization together with miR-485-3p measurements.

In addition to diagnosis, the disclosure provides a treatment concept for Alzheimer’s disease based on miR-485-3p. The treatment method includes measuring miR-485-3p expression to identify subjects having a high level of miR-485-3p relative to a control group and administering a nucleic acid complementary to miR-485-3p. Reported associations and effects are described in relation to ELAVL2, APP, Aβ42, and cognitive performance in a 5×FAD mouse model.

Claims Coverage

The partial content identifies one independent claim (clm-00001). The independent claim covers an Alzheimer’s treatment method that uses miR-485-3p expression measurement for subject identification followed by administration of a therapeutically effective amount of a nucleic acid complementary to miR-485-3p to subjects identified as having high miR-485-3p compared to a control group.

Measuring miR-485-3p expression to identify high-level subjects

The method comprises measuring the expression level of miR-485-3p in a sample from the subject, and identifying the subject as having a high level of miR-485-3p as compared to a control group.

Administering complementary nucleic acid to miR-485-3p

The method administers a therapeutically effective amount of a nucleic acid complementary to miR-485-3p to the subject that is identified as having a high level of miR-485-3p, as compared to a control group.

Across the identified independent claim, the core claim coverage is the combination of measuring miR-485-3p expression to select subjects with high miR-485-3p relative to a control group, and administering a therapeutically effective amount of a nucleic acid complementary to miR-485-3p for treating Alzheimer’s disease.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Alzheimer’s disease diagnostic use involving measuring miR-485-3p expression in a blood/plasma sample, optionally together with saliva-based amyloid beta 42 (Aβ42) quantification for cognitive impairment categorization.

Alzheimer’s disease treatment method using miR-485-3p expression measurement to identify subjects with high miR-485-3p and administering a nucleic acid complementary to miR-485-3p.

5×FAD mouse model studies are described in the document context for assessing related effects on ELAVL2, APP and Aβ42 and reported cognitive performance.

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