RecruitingNCT06837272

A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease

A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease: China Healthy Brain and Gut Microbiome Study (CHBGMS)

Sponsor

Jining Medical University

Enrollment

285 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Magnetic Resonance Imaging Alzheimer Disease Metabonomics Gut Microbiota

Summary

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.

Eligibility

Min Age: 60 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study explores whether changes in the gut microbiome — the trillions of bacteria living in your intestines — are linked to brain health changes in people at various stages of Alzheimer's disease risk, from normal cognition to mild cognitive impairment to dementia. **You may be eligible if...** - You are cognitively normal (no memory complaints and normal test results) - Or you have subjective cognitive decline (you feel your memory is worse but tests are still normal) - Or you have mild cognitive impairment (MCI) — memory and thinking problems that don't yet meet criteria for dementia - Or you have been diagnosed with Alzheimer's dementia - You are 60 or older if you are in the subjective cognitive decline group **You may NOT be eligible if...** - You have another cause of dementia (such as vascular dementia or Lewy body dementia) - You have taken antibiotics recently - You are unable to provide stool or blood samples Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTMulti-omics features extraction

Based on multi-omics features extracted from clinical data, gut microbiome, metabolomics, and multi-modal MRI, the diagnostic model of SCD due to preclinical AD will be established.