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Clinical Trials/NCT04804618
NCT04804618
Recruiting
N/A

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

Guangzhou University of Traditional Chinese Medicine1 site in 1 country650 target enrollmentJune 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer Disease, Early Onset
Sponsor
Guangzhou University of Traditional Chinese Medicine
Enrollment
650
Locations
1
Primary Endpoint
Changes in the protein expression profile of urine and saliva
Status
Recruiting
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
June 30, 2026
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Changes in the protein expression profile of urine and saliva

Time Frame: 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 Outcomes

  • Change of the cognitive function every year(An Average of 1 year)
  • Changes in plasma protein expression profile every year(An Average of 1 year)
  • Variation characteristics of gut microbiome every year(An Average of 1 year)

Study Sites (1)

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