Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04804618
Enrollment
650
Registered
2021-03-18
Start date
2021-06-01
Completion date
2026-06-30
Last updated
2022-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Early Onset, Protein; Disease

Keywords

Alzheimer Disease, biomarker, protein

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

Interventions

None listed

Sponsors

Guangzhou Cadre Health Management Center
CollaboratorUNKNOWN
Guangzhou University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
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;

Design outcomes

Primary

MeasureTime frameDescription
Changes in the protein expression profile of urine and salivaAn Average of 1 yearProteomic expression of urine and saliva in each group will be tested use Protein liquid chromatography/mass spectrometry detection.

Secondary

MeasureTime frameDescription
Change of the cognitive function every yearAn Average of 1 yearMini-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 yearAn Average of 1 yearProteomic expression of plasma in each group will be tested use Protein liquid chromatography/mass spectrometry detection.
Variation characteristics of gut microbiome every yearAn Average of 1 yearBacterial genomic DNA was extracted from faecal and tongue coating samples of each group using 16S RNA sequencing and analysis

Countries

China

Contacts

Primary Contactjianwen guo, Dr
306247680@qq.com13724899379

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026