Actively Recruiting
A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease
Led by Jining Medical University · Updated on 2025-02-20
285
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
J
Jining Medical University
Lead Sponsor
X
Xuanwu Hospital, Beijing
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gut microbiota dysfunction is associated with Alzheimer's disease (AD). However, the potential modulatory mechanism remains unclear. Previous studies have shown that gut-derived metabolites short-chain fatty acids (SCFAs) may be the key mediators between gut microbiota and brain, participating in the modulatory pathway "gut microbiota-SCFAs-brain networks". In this project, high-throughput targeted metabolomics technique will be used to explore the differences of SCFAs in the spectrum of AD, including cognitively normal individuals, subjective cognitive decline (SCD), mild cognitive impairment (MCI), and AD dementia. Then, the gut microbiome and multi-modal MRI techniques will be combined to elucidate potential interaction mechanisms of "gut microbiota-SCFAs-brain networks". Finally, based on multi-omics features extracted from gut microbiome, metabolomics, and neuroimaging after five years, the diagnostic model of SCD due to preclinical AD will be established using machine learning methods.
CONDITIONS
Official Title
A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cognitively normal group: normal performance on standardized cognitive tests with no cognitive complaints or concerns
- SCD group: self-experienced persistent memory decline, normal cognitive test results, not meeting criteria for MCI or dementia, onset age 60 years, onset within last 5 years, associated concerns, feeling worse than peers
- MCI group: impaired scores in at least one cognitive domain, Functional Activities Questionnaire score 9
- AD dementia group: criteria for dementia with impaired daily function, episodic memory deficit, Clinical Dementia Rating score 1
You will not qualify if you...
- History of stroke
- Major depression and anxiety
- Other central nervous system disorders causing cognitive impairment such as Parkinson's disease, tumors, encephalitis, epilepsy
- Cognitive impairment from traumatic brain injury
- Systemic diseases like thyroid dysfunction, syphilis, HIV
- Psychosis or congenital mental developmental delay
- Use of antibiotics, probiotics, prebiotics, or synbiotics within 3 months
- Use of corticosteroids, immune stimulating or immunosuppressive agents
- Major gastrointestinal surgery in past 5 years
- Severe gastrointestinal diseases affecting gut microbiota such as irritable bowel syndrome, inflammatory bowel disease, severe gastritis, or other digestion and absorption disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Neurolgy, the Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272029
Actively Recruiting
Research Team
C
Can Sheng, PhD
CONTACT
Y
Yun Guo, Master
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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