Proteomics Study of Mild Cognitive Impairment and Alzheimer's Disease

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

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

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease, Early Onset; Protein; Disease

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 650

Contacts and Locations

• Study Contact: Name: Jianwen Guo, Dr; Phone Number: 13724899379; Email: 306247680@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Guangdong Province Hospital of Tradtional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

From March 2021 to March 2022，people who finish the cognitive examination at Guangdong Provincial Hospital of Chinese Medicine and the Guangzhou Cadre Health Management Center would be this study population. All the eligible participants will be follow up every year until 2026.

Description

Inclusion Criteria:

1. Older than 55-year-old，male or female.
2. patients meet the diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease(AD) or whose family members were diagnoed with AD
3. Complete self-rating scale for memory impairment (AD-8 scale)
4. Those who agree to participate in clinical research and sign informed consent.

Exclusion Criteria:

1. Patients with acute cardiovascular and cerebrovascular diseases, acute infections (pneumonia, urinary tract infection, oral infection, digestive tract infection), severe renal dysfunction, and uremia;
2. Pregnant or lactating women;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Healthy control group; aged ≥55 years old, no dementia, MCI or no family history of AD.
Alzheimer's disease high-risk group; aged ≥55 years old, immediate family members of AD patients
Alzheimer's disease group; aged ≥55 years old, diagnosed as AD patients
Mild cognitive impairment group; patients ≥55 years of age, diagnosed with MCI

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine
• Collaborators: Guangzhou Cadre Health Management Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): June 30, 2026
• Study Completion (Anticipated): June 30, 2026

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: biomarker; Alzheimer Disease; protein
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: AD2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No