Proteomics Study of Mild Cognitive Impairment and Alzheimer's Disease

Alzheimer Disease, Early Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04804618
• Other study ID #: AD2020
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: November 2022
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: jianwen guo, Dr
• Phone: 13724899379
• Email: 306247680[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Early Onset
• Cognitive Dysfunction
• Protein; Disease

Locations

Country	Name	City	State
China	Guangdong Province Hospital of Tradtional Chinese Medicine	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine	Guangzhou Cadre Health Management Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	An Average of 1 year
Secondary	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.	An Average of 1 year
Secondary	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.	An Average of 1 year
Secondary	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	An Average of 1 year