Proteomics Study of Mild Cognitive Impairment and Alzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55+
SponsorGuangzhou University of Traditional Chinese Medicine
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
650 Participants
are grouped into 4 trial groupsGroup A: Healthy control group
Group B: Alzheimer's disease high-risk group
Group C: Alzheimer's disease group
Group D: Mild cognitive impairment group
Trial outcomes
Primary outcomes
1
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.
Time frame
An Average of 1 yearSecondary outcomes
1
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.
Time frame
An Average of 1 year2
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.
Time frame
An Average of 1 year3
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
Time frame
An Average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Guangzhou University of Traditional Chinese Medicine
Lead sponsor
Guangzhou Cadre Health Management Center
Collaborator
Source ClinicalTrials.gov