Proteomics Study of Mild Cognitive Impairment and Alzheimer's Disease

Sponsor
Guangzhou University of Traditional Chinese Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04804618
Collaborator
Guangzhou Cadre Health Management Center (Other)
650
60.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    650 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Exploring Research on Early Warning Indicators of Protein in Patients With Mild Cognitive Impairment and Alzheimer's Disease
    Anticipated Study Start Date :
    Apr 1, 2021
    Anticipated Primary Completion Date :
    Apr 30, 2026
    Anticipated Study Completion Date :
    Apr 30, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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;

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Guangzhou University of Traditional Chinese Medicine
    • Guangzhou Cadre Health Management Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guangzhou University of Traditional Chinese Medicine
    ClinicalTrials.gov Identifier:
    NCT04804618
    Other Study ID Numbers:
    • AD2020
    First Posted:
    Mar 18, 2021
    Last Update Posted:
    Mar 18, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guangzhou University of Traditional Chinese Medicine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 18, 2021