Clinical trial NCT04804618: Proteomics Study of Mild Cognitive Impairment and Alzheimer's Disease
Official title: Exploring Research on Early Warning Indicators of Protein in Patients With Mild Cognitive Impairment and Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease, Early Onset
Protein; Disease
Keywords: Alzheimer Disease
biomarker
protein
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Guangzhou Cadre Health Management Center
First posted: 2021-03-18
Enrollment: 650
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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

Eligibility criteria: 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;

Primary outcomes:
measure: Changes in the protein expression profile of urine and saliva
timeFrame: An Average of 1 year
Secondary outcomes:
measure: Change of the cognitive function every year
timeFrame: An Average of 1 year
measure: Changes in plasma protein expression profile every year
timeFrame: An Average of 1 year
measure: Variation characteristics of gut microbiome every year
timeFrame: An Average of 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Tradtional Chinese Medicine
state: Guangdong
Study officials:
References: