CN115480063A - Marker for predicting cognitive decline of Parkinson disease patient and application thereof - Google Patents
Marker for predicting cognitive decline of Parkinson disease patient and application thereof Download PDFInfo
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Abstract
The invention relates to a marker for predicting cognitive decline of a Parkinson disease patient and application thereof, and a hematological biomarker for predicting cognitive decline of the Parkinson disease patient is plasma p-tau181. A kit for predicting cognitive decline in a parkinson's disease patient, capable of determining the expression level of plasma p-tau181. The method monitors 184 Parkinson disease patients and 100 healthy contrasts matched with age, sex and the like, finds and predicts the cognitive function decline of the Parkinson disease patients, can adopt the plasma p-tau181, and can well predict the cognitive function decline of the Parkinson disease patients; access is easier and less traumatic than previous cerebrospinal p-tau181.
Description
Technical Field
The invention belongs to the technical field of biology, and particularly relates to a marker for predicting cognitive decline of a Parkinson disease patient and application thereof.
Background
Parkinson's Disease (PD) is a common nervous system degenerative disease of the middle-aged and the elderly, and is characterized by four symptoms of resting tremor, muscle stiffness or rigidity of four limbs, slow movement and dyskinesia.
The symptoms of parkinson's disease mainly include those affecting movement (motor symptoms) and those not related to movement (non-motor symptoms). Motor symptoms of parkinson's disease mainly include: resting tremor (i.e., the vibrations or tremors that occur at rest), myotonia, bradykinesia, postural gait disturbance, and the like. Cognitive decline and dementia are common non-motor symptoms in parkinson's disease patients, which can seriously affect the quality of life of the patient, increasing the burden on the caregiver.
At present, the research at home and abroad discovers a plurality of cerebrospinal fluid biomarkers which can possibly predict the dementia risk of the Parkinson disease patient, wherein pathological proteins related to the Alzheimer disease, including cerebrospinal fluid phosphorylated tau protein (p-tau 181), cerebrospinal fluid beta amyloid protein (A beta 42) and the ratio of the cerebrospinal fluid phosphorylated tau protein to the cerebrospinal fluid beta amyloid protein, are proved to have the potential of predicting the cognitive decline of the Parkinson disease. But the spinal puncture is an invasive examination, which causes difficulty in obtaining cerebrospinal fluid. It is therefore imperative and important to find readily accessible hematological biomarkers.
For this reason, this patent is filed.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides a marker for predicting cognitive decline of a Parkinson disease patient and application thereof, solves a plurality of problems caused by lumbar puncture, and finds a hematological biomarker for rapidly and effectively predicting cognitive decline of the Parkinson disease and a prepared kit.
The invention aims to provide a marker for predicting cognitive decline of a Parkinson disease patient and application thereof.
It is a further object of the present invention to provide a kit for predicting cognitive decline in a parkinson's disease patient.
A hematological biomarker for predicting cognitive decline in parkinson's disease patients according to a specific embodiment of the present invention is plasma p-tau181.
Further, plasma p-tau181, a hematological biomarker, was used to prepare kits for predicting cognitive decline in parkinson's disease patients.
A composition for predicting cognitive decline in a parkinson's disease patient according to a specific embodiment of the invention, the composition comprising a substance for detecting the level of plasma p-tau181 expression.
The composition comprises a Biotin (Biotin) modified p-Tau181 detection antibody (Detector), streptavidin-modified enzyme (SBG), fluorescently-tagged substrate (RGP), and Sample Diluent (Sample Diluent).
The concentration of p-tau181 in plasma tested by the simoa technique of the present invention.
Furthermore, the p-Tau181 protein in the plasma sample was detected using a fully automated simoa HD-X platform (quantrix, usa) from hangzhou corpio biotechnology limited, and the detection procedure was performed with reference to the instrument instructions.
A kit for predicting cognitive decline in a parkinson's disease patient according to a specific embodiment of the invention, said kit being capable of determining the expression level of plasma p-tau181.
Furthermore, the kit comprises magnetic beads, the surfaces of which are coated with p-Tau181 specific capture antibodies, biotin modified p-Tau181 detection antibodies, streptavidin modified enzymes and substrates with fluorescent labels.
Further, the kit for predicting cognitive decline in a parkinson's disease patient comprises primers and probes for plasma p-tau181.
The biomarker detection kit for predicting the curative effect of the anti-parkinson's disease drug according to the embodiment of the present invention is capable of determining the expression level of the plasma p-tau181.
Further, the biomarker detection kit for predicting the curative effect of the anti-Parkinson's disease drug comprises primers and probes of the plasma p-tau181.
The evaluation system for predicting cognitive decline of a Parkinson disease patient comprises a detection module and a calculation module, wherein the calculation module has a calculation formula of plasma p-tau181; the evaluation system is used for predicting cognitive decline of Parkinson disease patients.
The invention aims to find a hematological biomarker capable of replacing cerebrospinal fluid and predicting cognitive decline of Parkinson patients, the inventor collects large samples of Parkinson patients and peripheral blood of healthy controls matched with age, sex and the like, detects the levels of p-tau181, abeta 40 and Abeta 42 in plasma of all participants and APOE genotypes by using a hypersensitivity monomolecular array (simoa) technology, and carries out one-year long-term follow-up (the longest follow-up time is 5 years) on the patients, and scores the cognitive functions of the patients with each follow-up. Statistical analysis using a linear mixture model showed that baseline plasma p-tau181 levels are predictive of long-term cognitive decline in parkinson's disease patients.
Compared with the prior art, the invention has the beneficial effects that:
(1) The method monitors 184 Parkinson disease patients and 100 healthy contrasts matched with age, sex and the like, finds and predicts the cognitive function decline of the Parkinson disease patients, can adopt the plasma p-tau181 marker, and can better predict the cognitive function decline of the Parkinson disease patients; access is easier and less traumatic than previous cerebrospinal p-tau181.
(2) The kit can predict the cognitive function decline of the Parkinson disease patient.
(3) The following verification test results show that: patients with high p-tau181 levels at baseline (> 1.472 pg/ml) had a more rapid decline in cognitive score compared to low p-tau181 levels at baseline (< 1.472 pg/ml) (β -0.274[ -0.395-0.153 ], p = 0.023), suggesting: baseline plasma p-tau181 levels can be used as a hematological biomarker for predicting cognitive decline in parkinson's disease patients.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
FIG. 1 compares plasma p-tau181, A β 40, A β 42 levels;
FIG. 2 is a graph of the prediction of cognitive decline rate by the level of baseline p-tau181 levels.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be described in detail below. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the examples given herein without any inventive step, are within the scope of the present invention.
In some more specific embodiments, the hematological biomarker used to predict cognitive decline in a Parkinson's disease patient is plasma p-tau181 levels.
Further, plasma p-tau181 as a hematological biomarker and a kit for preparing a medicine for predicting cognitive decline of a patient with Parkinson's disease are provided.
A composition for predicting cognitive decline in a parkinson's disease patient, the composition comprising a substance for detecting the level of plasma p-tau181 expression.
The composition comprises a Biotin (Biotin) modified p-Tau181 detection antibody (Detector), streptavidin-modified enzyme (SBG), a fluorescent-tagged substrate (RGP), and a Sample Diluent (Sample Diluent).
A kit for predicting cognitive decline in a parkinson's disease patient, said kit being capable of determining the expression level of plasma p-tau181.
Further, the kit comprises magnetic beads (Capture beads) having a surface coated with a p-Tau 181-specific Capture antibody, biotin (Biotin) -modified p-Tau181 detection antibodies (Detector), streptavidin-modified enzymes (SBG), fluorescently labeled substrates (RGP), resoufin-D-galactopyranoside), and Sample dilutions (Sample Diluent).
A biomarker detection kit for predicting the efficacy of an anti-parkinson's disease drug, said kit being capable of determining the expression level of plasma p-tau181.
Example 1
The embodiment provides a marker for predicting cognitive decline of a Parkinson disease patient, and the screening method comprises the following steps:
1) 184 Parkinson patients and 100 healthy controls matched with age and sex are included in the baseline, the demographic characteristics such as sex, age, educational age and the like and the clinical characteristics such as disease course and the like of the patients are collected, and the cognitive function of the patients is evaluated by using a Montreal cognitive assessment scale (MoCA). And plasma p-tau181, a β 40 and a β 42 levels were measured in patients and healthy controls using simoa techniques.
2) The incorporated Parkinson disease patients are followed up once a year, the MoCA scores of the patients are re-evaluated at each follow-up, and the cognitive function change condition of the patients is monitored. And plasma p-tau181, a β 40 and a β 42 levels were again measured in patients at the first and second year follow-up visits. Patients were enrolled for a maximum follow-up time of 5 years.
3) The trends in plasma p-tau181, A β 40 and A β 42 levels and the A β 42/A β 40 and p-tau181/A β 42 ratios were compared using the Friedman test over a two-year follow-up period (three replicates) and the results showed: the p-tau181 level and the p-tau181/A β 42 ratio of Parkinson's disease patients increase year by year with the progression of the disease course, while the A β 40 and A β 42 levels decrease year by year (FIG. 1);
4) A linear mixture model was used to analyze whether baseline indicators could predict cognitive decline following: with repeatedly measured MoCA scores as dependent variables, fixed effects in independent variables included baseline individual index levels (translated into dichotomous variables: median as cutoff), follow-up time, baseline individual index levels x interactive terms at follow-up time, and corrected covariates (including gender, baseline age, age at education, baseline course, baseline MoCA scores). The random effect in the independent variable includes the intercept of the individual. The interaction term of the baseline index levels and the follow-up time reflects the influence of the baseline p-tau 181/Abeta 42 ratio on the change rate of the MoCA score, namely the prediction of the cognitive decline speed.
The results show that: patients with high p-tau181 levels at baseline (> 1.472 pg/ml) had a more rapid decrease in cognitive score (β -0.274[ -0.395-0.153 ], p = 0.023) compared to low p-tau181 levels at baseline (< 1.472 pg/ml) (as shown in figure 2), i.e. baseline plasma p-tau181 levels could be used as a hematological biomarker for predicting cognitive decline in parkinson's disease patients.
Example 2
Plasma p-tau181 of a hematological biomarker was used to prepare a kit for predicting cognitive decline in parkinson's disease patients. Detection of plasma p-tau181, patients with high p-tau181 levels at baseline (> 1.472 pg/ml) had a faster decline in cognitive score compared to patients with low p-tau181 levels at baseline (< 1.472 pg/ml).
A composition for predicting cognitive decline in a parkinson's disease patient, the composition comprising a substance for detecting the level of plasma p-tau181 expression.
In this example, the p-Tau181 protein in the plasma sample was detected using a fully automated Simoa HD-X platform (Quanterix, usa) from paozu, cryjaba biotechnology limited and a commercial NFL detection Kit (Simoa p-Tau181 advanced V2 Kit, # 103714) from Quanterix, with reference to the apparatus and Kit instructions.
The above description is only for the specific embodiments of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present invention, and all the changes or substitutions should be covered within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the appended claims.
Claims (6)
1. A hematological biomarker for predicting cognitive decline in a parkinson's disease patient, wherein the hematological biomarker is plasma p-tau181.
2. Use of a hematological biomarker for predicting cognitive decline in a parkinson's disease patient, wherein plasma p-tau181 of the hematological biomarker is used for the preparation of a kit for predicting cognitive decline in a parkinson's disease patient.
3. A composition for predicting cognitive decline in a parkinson's disease patient, said composition comprising a substance for detecting the level of plasma p-tau181 expression.
4. A kit for predicting cognitive decline in a parkinson's disease patient, wherein the kit is capable of determining the expression level of plasma p-tau181.
5. A biomarker detection kit for predicting the efficacy of an anti-parkinson's disease drug, wherein the kit is capable of determining the expression level of plasma p-tau181.
6. An assessment system for predicting cognitive decline in a parkinson's disease patient, comprising a detection module for determining the expression level of plasma p-tau181; the evaluation system is used for predicting cognitive decline of Parkinson disease patients.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20170292963A1 (en) * | 2014-09-19 | 2017-10-12 | The Johns Hopkins University | Biomarkers of cognitive dysfunction |
| US20240012012A1 (en) * | 2020-12-01 | 2024-01-11 | Meredith Hay | Biomarker and treatment for vascular cognitive impairment and related conditions |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20170292963A1 (en) * | 2014-09-19 | 2017-10-12 | The Johns Hopkins University | Biomarkers of cognitive dysfunction |
| US20240012012A1 (en) * | 2020-12-01 | 2024-01-11 | Meredith Hay | Biomarker and treatment for vascular cognitive impairment and related conditions |
Non-Patent Citations (2)
| Title |
|---|
| JAVIER PAGONABARRAGA 等: "Dissociable contribution of plasma NfL and p-tau181 to cognitive impairment in Parkinson\'s disease", PARKINSONISM & RELATED DISORDERS, vol. 105, 8 June 2022 (2022-06-08), pages 132 - 138 * |
| 丁俭, 章杰锦, 李俊毅, 等: "帕金森病血浆神经退行性蛋白与非运动症状的关系", 中华老年心脑血管病杂志, vol. 21, no. 5, 15 May 2019 (2019-05-15), pages 506 - 510 * |
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