Proteomics Study of Mild Cognitive Impairment and Alzheimer's Disease

Study Overview
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Brief Summary
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This study intends to adopt standardized and rigorous cross-sectional research, collect biological specimens (including blood, feces, urine, saliva and tongue coating) from eligible subjects, and use liquid chromatography/mass spectrometry (LC-MS/MS) technology to explore early warning indicators of protein in patients with mild cognitive impairment and Alzheimer's disease

Detailed Description
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The problem of population aging is getting worse, the prevalence of senile dementia is increasing, and Alzheimer's disease (AD) is the most common type of dementia. There is no effective treatment for AD. Most interventions can only alleviate the condition and delay the development. Therefore, early diagnosis and prevention of AD are extremely important. However, the current diagnostic measures are not suitable for clinical promotion due to their traumatic nature, so there is an urgent need for a more suitable clinical early identification and diagnosis method. Proteomics research technology is the leading research technology in China. It can be applied to research on disease markers, pathogenesis, and drug target discovery. Therefore, this study intends to adopt standardized and rigorous cross-sectional research, collect biological specimens (including blood, feces, urine, saliva and tongue coating) from eligible subjects, and use liquid chromatography/mass spectrometry (LC-MS/MS) technology to explore early warning indicators of protein in patients with mild cognitive impairment and Alzheimer's disease

Official Title
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Exploring Research on Early Warning Indicators of Protein in Patients With Mild Cognitive Impairment and Alzheimer's Disease

Conditions
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Alzheimer Disease, Early Onset, Protein; Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 55-year-old，male or female. patients meet the diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease(AD) or whose family members were diagnoed with AD Complete self-rating scale for memory impairment (AD-8 scale) Those who agree to participate in clinical research and sign informed consent. Exclusion Criteria: Patients with acute cardiovascular and cerebrovascular diseases, acute infections (pneumonia, urinary tract infection, oral infection, digestive tract infection), severe renal dysfunction, and uremia; Pregnant or lactating women;

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy control group<br>aged ≥55 years old, no dementia, MCI or no family history of AD. | |
| Alzheimer's disease high-risk group<br>aged ≥55 years old, immediate family members of AD patients | |
| Alzheimer's disease group<br>aged ≥55 years old, diagnosed as AD patients | |
| Mild cognitive impairment group<br>patients ≥55 years of age, diagnosed with MCI | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the protein expression profile of urine and saliva | Proteomic expression of urine and saliva in each group will be tested use Protein liquid chromatography/mass spectrometry detection. | An Average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the cognitive function every year | Mini-mental State Examination (MMSE) score for the the cognitive function assessment. The total score in MMSE ranges from 0 to 30, and higher scores indicate better cognition. | An Average of 1 year | 
| Changes in plasma protein expression profile every year | Proteomic expression of plasma in each group will be tested use Protein liquid chromatography/mass spectrometry detection. | An Average of 1 year | 
| Variation characteristics of gut microbiome every year | Bacterial genomic DNA was extracted from faecal and tongue coating samples of each group using 16S RNA sequencing and analysis | An Average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer Disease, biomarker, protein