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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-80
SponsorJining Medical University

About this trial

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 criteria

Qualifiers

normal performance on standardized cognitive tests;

with no cognitive complaints or any concerns (worries).

self-experienced persistent decline in memory, rather than other domains of cognition;

normal performance on standardized cognitive tests;

Disqualifiers

a history of stroke;

major depression and anxiety;

other central nervous system disorders that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis, and epilepsy;

cognitive impairment caused by traumatic brain injury;

Trial design

Treatments tested in this trial

  • Multi-omics features extraction

Treatment groups

285 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Jining Medical University

Lead sponsor

Xuanwu Hospital, Beijing

Collaborator