An observational study in Alzheimer Disease, Early Onset and Protein; Disease, sponsored by Guangzhou University of Traditional Chinese Medicine. Recruiting at 1 site in China. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by Guangzhou University of Traditional Chinese Medicine · Observational
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
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
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 650 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Guangzhou University of Traditional Chinese Medicine is the lead sponsor of 57 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
aged ≥55 years old, no dementia, MCI or no family history of AD.
aged ≥55 years old, immediate family members of AD patients
aged ≥55 years old, diagnosed as AD patients
patients ≥55 years of age, diagnosed with MCI
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 year
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 year
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 year
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 year
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Guangzhou University of Traditional Chinese Medicine