Method for diagnosis of Alzheimer's disease using microrna
Inventors
Ryu, Jin-Hyeob • Cho, Hyun-Jeong
Assignees
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Publication Number
US-12084718-B2
Publication Date
2024-09-10
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 invention relates to determining expression level of miR-485-3p in a subject in need of a therapy for an Alzheimer's disease and/or a brain disease. A sample from the subject is contacted with a nucleic acid complementary to miR-485-3p, and the expression level of miR-485-3p in the sample is measured.
The invention addresses diagnosing Alzheimer’s disease and differentiating cognitive impairment by measuring miR-485-3p expression from patient blood. The measurement supports quick and objective diagnosis, including differentiation between mild cognitive impairment and severe cognitive impairment.
The invention further relates to combining miR-485-3p measurement with saliva amyloid beta 42 (Aβ42) concentration, using diagnostic criteria based on miR-485-3p fold-change and Aβ42 ranges to distinguish normal, mild cognitive impairment, and severe impairment. Documented support includes miR-485-3p being significantly increased in Alzheimer’s patients, and identification of ELAVL2 as a miR-485-3p target via a conserved seed match to the 3′-UTR of ELAVL2.
Claims Coverage
The document includes one independent claim. It covers a method for determining miR-485-3p expression in a subject needing therapy for Alzheimer’s disease and/or selected brain diseases by contacting a subject sample with a nucleic acid complementary to miR-485-3p and measuring miR-485-3p expression, with the claim set identifying multiple inventive refinements including probe design constraints and sample/measurement/diagnostic threshold refinements, including optional Aβ42-based diagnostic ranges.
Determining miR-485-3p expression using a complementary nucleic acid probe
A method of determining the expression level of miR-485-3p in a subject in need of a therapy for an Alzheimer's disease and/or a brain disease by contacting a sample from the subject with a nucleic acid complementary to miR-485-3p and measuring the expression level of miR-485-3p in the sample.
Selecting the brain disease from a defined group
The method of determining miR-485-3p expression wherein the brain disease is selected from the group consisting of autism spectrum disorder, mental retardation, amyotrophic lateral sclerosis, seizure, stroke, Parkinson's disease, spinal cord injury, and any combination thereof.
Using a quantitative miR-485-3p expression threshold versus controls
The method where the expression level of miR-485-3p in the sample is at least 5 times higher than in a control group.
Employing a miR-485-3p complementary nucleic acid within a length range
The method where the nucleic acid complementary to miR-485-3p is 15–30 nucleotides long.
Targeting defined regions within a SEQ ID NO: 1 sequence
The method where the nucleic acid complementary to miR-485-3p is complementary to either bases 1–19 or bases 14–22 of SEQ ID NO: 1 from the 5′ end.
Using a miR-485-3p complementary nucleic acid containing a nucleotide analog
The method where the nucleic acid complementary to miR-485-3p contains a nucleotide analog.
Defining MCI based on an Aβ42 concentration range
The method that determines the subject has mild cognitive impairment (MCI) when the concentration of Aβ42 is at least 500 pg/mL and below 1 ng/mL.
Overall, the claim coverage centers on measuring miR-485-3p expression using a nucleic acid complementary to miR-485-3p, with the brain disease limited to a defined group and multiple refinements that constrain probe design and measurement by adding quantitative expression thresholds and, in related claim support, defining diagnostic categories using Aβ42 concentration ranges.
Stated Advantages
Objective, noninvasive diagnosis using patient blood miR-485-3p measurement.
Quick and accurate diagnosis.
Helps differentiate mild cognitive impairment versus severe impairment.
Reducing patient risk by optionally combining miR-485-3p measurement with saliva Aβ42 concentration.
Documented Applications
Diagnosing Alzheimer’s disease by measuring miR-485-3p expression in a patient sample.
Differentiating mild cognitive impairment from severe cognitive impairment using miR-485-3p fold-change and optionally saliva Aβ42 concentration ranges.
Monitoring that a subject has mild cognitive impairment (MCI) based on Aβ42 concentration when using the described diagnostic approach.
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