Proteomics Study of Mild Cognitive Impairment and Alzheimer's Disease

Recruiting

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

• Registration Number: NCT04804618
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-02-20
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-18
• Study Start: 2021-06-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-15
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the protein expression profile of urine and saliva	An Average of 1 year	Proteomic expression of urine and saliva in each group will be tested use Protein liquid chromatography/mass spectrometry detection.

Secondary Outcome Measures

Name	Time	Method
Change of the cognitive function every year	An Average of 1 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.
Changes in plasma protein expression profile every year	An Average of 1 year	Proteomic expression of plasma in each group will be tested use Protein liquid chromatography/mass spectrometry detection.
Variation characteristics of gut microbiome every year	An Average of 1 year	Bacterial genomic DNA was extracted from faecal and tongue coating samples of each group using 16S RNA sequencing and analysis

Trial Locations

Locations (1)

Guangdong Province Hospital of Tradtional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China