Plasma miRNA Marker Panel for Early MCI Due to Alzheimer's Detection

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Solution Overview

Problem

Current diagnostic methods for mild cognitive impairment due to Alzheimer's disease (AD) are limited, lacking convenient and minimally invasive peripheral plasma markers, and existing clinical biomarkers are not widely applicable in China, posing a significant challenge for early detection and intervention.

Innovation Solution

Development of a diagnostic marker comprising plasma microRNAs (hsa-miR-1185-2-3p, hsa-miR-22-5p, hsa-miR-134-3p, hsa-miR-1909-3p, and hsa-miR-107) for MCI due to AD, integrated into a diagnostic kit with a calculation formula for early detection and intervention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If brain senile plaque imaging detection is used, then early detection of AD is possible, but the cost is very high and it has no clinical application in China

Engineering Contradiction:
Improveearly detection capabilityVSAvoidclinical applicability and cost
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The patent uses plasma miRNA as a molecular copy or proxy marker to reflect brain pathology without requiring direct brain imaging. This molecular copy approach allows early detection of AD through peripheral blood testing, avoiding the need for expensive and unavailable brain imaging techniques while maintaining diagnostic accuracy.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent introduces plasma miRNA as an intermediary marker between brain pathology and clinical diagnosis. This intermediary substance can be easily obtained from peripheral blood, serving as a bridge to detect AD early without requiring direct brain imaging or invasive procedures.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If cerebrospinal fluid examination is used, then pathological marker detection is possible, but it requires serious invasive operations and cannot be actually used in clinical early diagnosis

Engineering Contradiction:
Improvepathological marker detectionVSAvoidinvasiveness and clinical usability
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent extracts and utilizes miRNA from plasma, a non-invasive peripheral sample, to detect AD pathology. This extraction approach replaces the need for invasive cerebrospinal fluid lumbar puncture, allowing pathological marker detection through simple blood drawing while maintaining diagnostic accuracy.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses plasma miRNA expression patterns as a molecular copy of brain pathology. This copying approach enables detection of AD-related pathological changes through peripheral blood, eliminating the need for invasive cerebrospinal fluid examination while preserving diagnostic capability.

Inventive Principle:
Principle #26Copying

3Measurement precision

If brain structure imaging examination is used, then structural changes can be detected, but it cannot be used for early detection of MCI caused by AD

Engineering Contradiction:
Improvestructural change detectionVSAvoiddetection timing for MCI
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent detects AD-related changes in plasma miRNA expression before structural brain changes occur. By monitoring molecular markers in advance, the system enables early detection of MCI and preclinical AD stages, allowing intervention before irreversible structural damage happens.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces plasma miRNA as an intermediary early-warning marker that reflects pathological changes before they manifest as detectable structural abnormalities in brain imaging. This intermediary approach enables detection of MCI and early AD stages that traditional structural imaging misses.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If traditional diagnostic criteria are used, then diagnosis can be made, but there is no clinically applicable early diagnosis method of clinical biomarkers in China

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidclinical applicability in China
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent changes the diagnostic parameter from traditional clinical assessment and brain imaging to plasma miRNA expression profiling. This parameter transformation enables early diagnosis of AD and MCI through molecular biomarkers that can be measured in routine plasma samples, making the diagnosis method adaptable to Chinese clinical settings.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses plasma miRNA expression patterns as a molecular copy of AD pathology that can be detected in routine blood tests. This copying approach provides a clinically applicable early diagnosis method that works within the Chinese healthcare system, replacing the need for expensive imaging and invasive procedures.

Inventive Principle:
Principle #26Copying

Data Source

PatentUS12503732B2Diagnostic marker of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and uses thereof
Publication Date: 2025.12.23 SHANGHAI MENTAL HEALTH CENT (SHANGHAI PSYCHOLOGICAL COUNSELLING TRAINING CENT)
  • US12503732B2 patent drawing
  • US12503732B2 patent drawing
  • US12503732B2 patent drawing

AI summary

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.